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What Does It Mean to Participate in a Clinical Trial?
Participating in a clinical trial is voluntary and a personal choice. Clinical trials are research studies that involve people and are an important part of patient care. What is a clinical trial? Clinical trials are research studies that involve people, and they are an important part of patient care. There are several different types of clinical trials; some are designed to understand trends in a disease or identify better ways to diagnose a condition, while others determine if a new treatment is safe and works when treating, improving or preventing a health condition. There are over 400,000 clinical trials currently being conducted in the United States, and even more across the world. This includes health conditions such as heart failure, cancer, Parkinson’s Disease, respiratory conditions like COPD, common infections, cystic fibrosis, and many more. Clinical trials lead the healthcare industry to new discoveries that contribute to reliable and exact care, improving healthcare quality and saving lives. Clinical trials are conducted by a team of researchers, including doctors, pharmacists and clinical research coordinators. These research teams are highly skilled in their specialty areas, often providing traditional patient care and seeing research patients in the same day. These teams are responsible for making sure the clinical trial is completed correctly, and their patients are their top priority. Why should I consider participating in a clinical trial? Participating in a clinical trial is voluntary and a personal choice. There are many reasons why patients decide to get involved in clinical research. While many clinical trials are designed for patients who have a certain health condition, many studies also ask healthy volunteers to contribute in order to compare health outcomes. Clinical trials are also for patients at all different stages of their diagnosis. Depending on the specific study, the patient may receive access to a new cutting-edge treatment before it is widely available. When patients join a clinical trial, the research team becomes a health partner dedicated to their health and well-being. When patients join a clinical trial, they make an informed decision in their healthcare by weighing all available options in addition to routine treatments. Research participants know that they are contributing meaningfully and helping other patients like them. Where can I find more information about clinical trials at Renown Health? Renown Health’s mission is to make a genuine difference in the health and well-being of the communities we serve. Renown’s clinical trial portfolio offers leading care options to patients in northern Nevada, close to home, in a variety of specialties. Contact the Renown Clinical Research Office for more information on clinical trials available to you!
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Keeping Research Close to Northern Nevada
Clinical research provides agency for our patients navigating a scary diagnosis, and the field has never been stronger in northern Nevada. This strength is thanks in part to the Affiliate Clinical Research Office (ACRO) formed by the 2021 affiliation between Renown Health and the University of Nevada, Reno School of Medicine. Since its creation, the ACRO team has been busy ensuring that community members have access to the latest care options and exceptional experiences as participants in both research and their healthcare. Here are just a few things that set this office apart from the rest. 1. A focus on engagement In 2022, the ARCO team focused on promoting a research culture with patients, clinicians, residents and students by intentionally engaging with healthcare providers, department administrators, internal research team members and leadership. They educated the community with learning materials that emphasized the importance of doing research. This team also worked with front-line staff to raise awareness and excitement about the clinical research options available for Renown Health patients. 2. Meaningful partnerships The most impactful partnership to date is between Renown Health and UNR Med. By identifying opportunities and leveraging resources across institutions, we have maximized our impact and built a solid and sustainable foundation. This gives the people of northern Nevada greater access to new interventions or novel treatments. This team is also investing in the community and national partnerships to provide training opportunities for our research staff and learning opportunities for our medical students. 3. Novel treatments across many disease areas Our research study offerings must reflect the healthcare needs of our community and the expertise of practicing clinicians. The department has over 80 active studies in neurology, pulmonology, oncology, cardiology, pediatrics and disease prevention. The ARCRO team strives to expand care opportunities to allow our community members to stay close to home when seeking care. This year, they will continue exploring our community's unmet healthcare needs by bringing new treatment options to the greater Reno area.
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Clinical Research: Advancing Healthcare in Northern Nevada One Study at a Time
Did you know that the Renown Research Office has partnered with the University of Nevada, Reno School of Medicine Clinical Research Office to form the Integrated Clinical Research Office? This means we are able to provide more clinical research opportunities and expertise to our northern Nevada community than ever before. Over the past two years, we have significantly expanded our clinical trial offerings from 35 to 101 studies to meet the healthcare needs of our community members and keep care options local. Currently, we offer clinical research as a care opportunity in areas such as cardiology, pulmonology, endocrinology, oncology, pediatrics, neurology and immunizations. What is Clinical Research? Clinical research is simply medical research that involves human volunteers (participants). Research studies have to be reviewed and approved by ethics committees to ensure that the questions researchers want to answer are appropriate and that research participants are protected throughout the study. Often when we talk about clinical research, we are referring to a clinical trial. Clinical trials are a type of clinical research study that places research participants into groups to study the safety and effectiveness of new medications and devices on a specific health outcome. Clinical trials follow rigorous standards and must pass four phases of testing, where each phase works progressively to understand the correct dosing and effects in larger and more diverse groups of people. Why is Clinical Research Important? Did you know that all medications, diagnostic tests and medical devices prescribed and used today by physicians and health practitioners were once tested in clinical trials? Clinical research advances medical care by helping us understand how to prevent disease and to provide new and better treatments for a wide range of health conditions. At Renown Health, we know the importance of offering the latest opportunities in healthcare, especially when standard of care options have been exhausted. What Are Some Considerations for Participating in Clinical Research? Research volunteers are often drawn to participating in studies because they are interested in accessing the latest health care treatments and/or they want to contribute to scientific discovery. If you are interested in becoming a research volunteer, you should first make sure you fully understand what the study and researcher is asking you to do and consider whether you are comfortable with the study activities and commitments to time and travel such as for required study appointments. Remember, participating in a research study is completely voluntary. That means you choose whether to participate, and you can choose to stop participating in a research study at any time, for any reason. Where Can I Find More Information About Clinical Research? There are many resources you can access if you have questions or want to learn more about clinical research. Your healthcare provider can assist you in your healthcare journey by discussing care options and exploring if participating in a clinical trial may be right for you. The Nevada Division of Public and Behavioral Health recently launched their Clinical Trials Info for Nevadans webpage which provides information on finding clinical trials in Nevada, understanding the importance of diversity in clinical trials, and linked resources to learn more about clinical trials. The U.S. Department of Health and Human Services Office for Human Research Protections provides informational videos, questions to ask researchers prior to participating and information on regulations in place to protect research participants. Finally, at the Renown Research Office, we are always here to support your clinical research journey and can be reached at Renown-CRD@renown.org or 775-982-3646. At Renown Health, our goal is to make it easy for patients to access clinical research as a care opportunity where patients can access a variety of standard care treatment options for their health condition or choose to participate in a clinical trial. For more information about clinical trial opportunities available to you or to ask any questions, contact the Renown Research Office at Renown-CRD@renown.org or 775-982-3646.
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Optimizing Mammogram Screenings: A Genetic Approach to a Personalized Screening Schedule
© Arthon Meekodong via Canva.com Breast cancer screening has long been a cornerstone of women's healthcare. With 1 in 8 women diagnosed with breast cancer in their lifetime1, the United States Preventive Services Task Force (USPSTF) has developed screening recommendations to help detect early-stage cancer. Notably in 2023, the USPSTF revised the recommended age for biennial mammogram screenings for women with average risk to start at age 40 instead of 502, estimated to result in 19% more lives being saved3 by starting screening earlier. While initiating screening at an earlier age offers advantages to a wide demographic, concerns about the potential of over-screening prompted research into the feasibility of identifying women with lower breast cancer risk who could safely delay mammograms. While guidelines address high-risk individuals, a notable gap exists in providing recommendations tailored to those at lower risk. To gain insight into a patient's risk level, physicians are able to utilize genetic testing to understand an individual's genetic makeup, providing precise insights into their predisposition to various health conditions, including breast cancer. Armed with this genetic information, healthcare providers could craft tailored screening strategies that align with an individual’s specific risk profile. This genetic risk-based approach underscores the value of genetics in individualizing the onset of screening to help avoid over-screening and its associated costs. Surprisingly, genetic information is not currently being widely utilized to identify women at risk of breast cancer or other diseases in clinical practice, despite its potential to make a significant positive impact for patients. A recent retrospective analysis of 25,591 women from the Healthy Nevada Project4 sheds light on the potential benefits of this genetic risk-based approach. The study classified 2,338 (9.1%) of these women as having a low genetic risk for breast cancer. What's remarkable is that these women exhibited a significantly lower and later onset of breast cancer compared to their average or high-risk counterparts. This finding suggests that it might be safe for low-risk women to delay mammogram screening by 5 to 10 years without compromising their health.
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Study Shows Importance of Ensuring Participant and Provider Follow-up After a Genetic Screening Result
Released in partnership with the Desert Research Institute: New research from the Healthy Nevada Project® finds that a confirmed diagnosis does not always result in changes to patient care. Presenting individuals with potentially life-altering health information doesn’t mean the individuals – or their healthcare providers – will act on it. Follow-up education and conversations about actionable care plans with patients and their doctors are key next steps, according to new research from the Healthy Nevada Project. The Healthy Nevada Project is a genetic screening and research project that launched in 2016 as a partnership between DRI and Renown Health. The project now has more than 50,000 participants, with genetic sequencing provided by Helix. Between September 2018 and September 2020, the Healthy Nevada Project successfully notified 293 participants that they were genetically at risk for hereditary breast and ovarian cancer syndrome, Lynch syndrome, or familial hypercholesterolemia – three common genetic conditions known collectively as the Centers for Disease Control and Prevention (CDC) Tier 1 conditions. In a study published today in Frontiers in Genetics, Healthy Nevada Project scientists looked at the impact that notifying a patient of a positive finding for a CDC Tier 1 condition had on the care that the patient received in the months and years that followed. According to their results, among the 293 Healthy Nevada Project participants who were notified of their genetic risk of a CDC Tier 1 condition, 71 percent of participants with electronic health records shared their findings with healthcare providers. However, only 30 percent of the electronic health records for these patients contained documentation of the genetic diagnosis, and only 10 percent of examined patients experienced a possible change in care after receiving the results of their genetic screening. “The Healthy Nevada Project was implemented with a ‘hands-off’ approach where the participants receive their findings and decide with whom and when to share those findings. The findings were not automatically added to their electronic health records,” said Dr. Gai Elhanan, health data scientist at DRI and co-lead author of the study. “What we’re learning now is that to ensure that important genetic findings are integrated into the care journey it is important to make their inclusion into the electronic health records part of the study.” This study builds on previous Healthy Nevada Project research published in Nature Medicine demonstrating the importance of screening for CDC Tier 1 conditions, which affect about one in 75 individuals and can be mitigated or even prevented from developing into disease when detected early. This study found that as many as 90 percent of the CDC Tier 1 cases are missed by clinical providers during normal clinical care screenings and examinations. During the current study, the Healthy Nevada Project scientists found that 19 percent of studied participants had already developed one of the CDC Tier 1 conditions, and thus would have potentially benefited from earlier notification about their condition. The study team hopes that their findings will encourage individuals in Nevada to obtain genetic testing for these relatively common conditions. Even if individuals are older or have already suffered from diseases related to these conditions, testing could also prove beneficial to siblings, children, and grandchildren who may also be at risk and who could subsequently be screened in the event of a positive finding. The study team also encourages informing health care providers of the importance of incorporating genetic diagnoses into the pharmaceutical (for example, for Familial Hypercholesterolemia) and treatment advice given to patients. “As a result of this analysis, the clinicians at Renown Health and the Healthy Nevada Project researchers have made significant changes, including obtaining informed consent from participants to report positive findings from their genetics reports directly into their electronic medical record,” said Daniel Kiser, M.S., assistant research scientist of data science at DRI and co-lead author of the study. “This will help both participants, their clinical providers, and the whole state maximize the long-term benefits of the Healthy Nevada Project voluntary population-based genetic screening.” Additional information: The full text of the study, Incomplete Penetrance of Population-Based Genetic Screening Results in Electronic Health Record, is available from Frontiers in Genetics: https://www.frontiersin.org/articles/10.3389/fgene.2022.866169/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Genetics&id=866169. This project was funded by Renown Health, the Renown Health Foundation, and the Nevada Governor’s Office of Economic Development. Study authors included Gai Elhanan (DRI), Daniel Kiser (DRI), Iva Neveux (DRI), Shaun Dabe (Renown Health), Alexander Bolze (Helix), William Metcalf (DRI), James Lu (Helix), and Joseph Grzymski (DRI/Renown Health). For more information on the Healthy Nevada Project® or to request genetic screening, please visit: https://healthynv.org/ About DRI The Desert Research Institute (DRI) is a recognized world leader in basic and applied environmental research. Committed to scientific excellence and integrity, DRI faculty, students who work alongside them, and staff have developed scientific knowledge and innovative technologies in research projects around the globe. Since 1959, DRI’s research has advanced scientific knowledge on topics ranging from humans’ impact on the environment to the environment’s impact on humans. DRI’s impactful science and inspiring solutions support Nevada’s diverse economy, provide science-based educational opportunities, and inform policymakers, business leaders, and community members. With campuses in Las Vegas and Reno, DRI serves as the non-profit research arm of the Nevada System of Higher Education. For more information, please visit www.dri.edu. About Renown Health Renown Health is the region’s largest, locally governed, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California. With a diverse workforce of more than 7,000 employees, Renown has fostered a longstanding culture of excellence, determination and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the region’s largest, locally owned not-for-profit insurance company, Hometown Health. Renown is currently enrolling participants in the world’s largest community-based genetic population health study, the Healthy Nevada Project®. For more information, visit renown.org. About Helix Helix is the leading population genomics and viral surveillance company operating at the intersection of clinical care, research, and data analytics. Helix enables health systems, life sciences companies, payers, and government partners to accelerate the integration of genomic data into patient care and public health decision making. Learn more at www.helix.com.
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Celebrating Blood Sugar Balance This Holiday Season
As the holiday season draws near, we find more reasons to celebrate with loved ones. At Renown Health, we are kicking off the celebrations early this November with American Diabetes Month. Approximately 37 million Americans, including 270,000 Nevadans, have been diagnosed with diabetes with as many as 95% of those diagnosed living with type 2 diabetes mellitus (T2DM). What is Type 2 Diabetes? Type 2 diabetes is a chronic health condition that occurs because your body is not using insulin (a hormone made by the pancreas to help cells use the food we eat for energy) as well as it should, resulting in high blood sugar levels. It is important to obtain a diagnosis for T2DM and ensure it is well-controlled to prevent serious health complications. Those with diabetes are at higher risk for blindness, kidney failure, heart disease, stroke and amputation. Tips for Supporting Your Health with Type 2 Diabetes Know Your Blood Sugar Levels: Work with your healthcare provider to establish target blood sugar levels, and make sure to monitor your levels regularly as advised by your healthcare provider to prevent or delay health complications associated with T2DM. Focus on Your Plate: Eating foods such as fruits and vegetables, lean meats or plant-based proteins, healthy fats and whole grains supports diabetes management. If choosing healthy foods is difficult due to your busy schedule, cost or simply because you aren’t sure where to start, talk with your healthcare provider who may refer you to a registered dietitian. Registered dietitian nutritionists are certified nutrition specialists who can provide education and practical tips for eating to support your T2DM diagnosis with visits covered by many insurance plans. Prioritize Staying Active: Engaging in regular exercise is good for everyone, especially those living with T2DM. Exercise helps your cells become more sensitive to insulin and therefore supports healthy blood sugar levels. Always check with your healthcare provider prior to beginning a new exercise plan. Support Stress Reduction: Stress is unavoidable but can be managed through regular exercise, getting enough quality sleep (7-8 uninterrupted hours per night) and practicing meditation and other mindfulness techniques. Plan Ahead for Holiday Gatherings: There’s still room for celebration while focusing on blood sugar management. Consider bringing a healthy dish to your gathering, focus on filling your plate with vegetable sides and eating those first and incorporate a family walk after dinner. If traveling, pack nutritious snacks that support your health and keep you full. Lastly, enjoy the special dishes and desserts this season has to offer in single-serving portions.
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Understanding Your Risks for Fatty Liver Disease
Did you know that about one in four adults and one out of every ten kids in the U.S. might have a liver problem called non-alcoholic fatty liver disease (NAFLD)? This happens when too much fat builds up in the liver, and it's not because of drinking alcohol. The most serious type of this liver problem is called metabolic and non-alcoholic steatohepatitis (M/NASH). It means there's damage and can be scarring in the liver. About 20% of people with fatty liver disease have M/NASH. What's worrying is that many people don't even know they have it. Dr. Catherine McCarthy, a family medicine doctor at the University of Nevada, Reno School of Medicine, talks about the main risks of M/NASH and how you can check your risk for liver disease during Liver Health Matters Month, or anytime. Who Might Get M/NASH? Doctors aren't sure exactly why some people get fatty liver or M/NASH. While anyone can get M/NASH, people who might be more at risk include those with: Type 2 diabetes Insulin resistance or prediabetes High body mass index (BMI) or obesity High cholesterol or other fats in the blood High blood pressure Signs of liver problems from tests or biopsies A family member living with M/NASH How Do Doctors Find Out If You Have M/NASH? Doctors can do different checks and tests to see if someone has fatty liver or M/NASH. They might look at your liver health through non-invasive tests such as blood work, ultrasounds or MRIs. They might also suggest a special blood test called an Enhanced Liver Fibrosis (ELF) test– offered at no-cost through the Healthy Nevada Project – to check your risks of advancing liver disease. How Can You Treat Fatty Liver Disease or M/NASH? Patients with moderate to advanced liver scarring may also be prescribed a recently approved therapy called Rezdiffra. However, prevention of advancing disease is still the best option. Actions you can take to improve your liver health and reduce your risk include: Eating healthy, especially low-carb foods Exercising regularly Losing weight if needed Not drinking alcohol Keeping an eye on blood sugar if you have diabetes No-Cost Liver Screening Through the Healthy Nevada Project If you live in Nevada and are 18 or older, you can qualify for a no-cost liver health screening by enrolling in the Healthy Nevada Project, one of the largest community-based population health studies in the entire country. This study helps doctors understand your liver health better and plan early treatments to stop liver disease from getting worse. By joining the Healthy Nevada Project, you can: Get the FDA-approved ELF test to check your risks for liver disease See your test results in your medical record to help your doctor plan your care better Help doctors and researchers learn more about M/NASH and work on future treatments Participate in genetic sequencing for high-risk conditions linked to heart disease and certain cancers, including breast and ovarian cancer Gain high-level health insights, including food sensitivities, and ancestry information. Enrolling in the study is easy: Schedule a Virtual Consent Appointment through MyChart where a study representative will answer any questions, confirm your eligibility and sign you up. Once you’re signed up, your representative will schedule your blood test. Go to your blood draw appointment. By taking part in this study, you're helping to make a difference in liver health research!
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Department Spotlight Clinical Research
May 20 is National Clinical Trials Day. Celebrate with us by recognizing the Clinical Research team at Renown Health! The root of every medication, treatment and procedure in healthcare can be traced back to research. From the beginning of the history of medicine, research has always played a crucial role in improving the lives of patients around the world, leaving a permanent mark on how we expand our medical capabilities to this day. Renown Health’s Clinical Research team, in partnership with the University of Nevada, Reno School of Medicine (UNR Med), are leading that effort in our very own community. As our in-house leaders of clinical trials, this team is dedicated to advancing the science of medicine to help further our bottom line of making a genuine difference in the health and well-being of the patients they serve. Trial by (Medical) Jury Every day looks different for the Clinical Research team, especially when it comes to interacting with patients, providers and “sponsors,” which are the organizations providing the treatment for the study. One fact always remains true: communication and collaboration are key, especially among the team who act as the face of this process. Meet Lisa English (pictured above on the far right in a blue shirt), a Lead Clinical Research Coordinator at Renown who serves as the study "project manager." One aspect of Lisa’s day-to-day is seeing patients through their clinical trials from start to finish. It all begins with the setup. “Before we can launch a study, there is a lot of back-and-forth dialogue between everyone involved to ensure the best fit,” said Lisa. “Sponsors will come to us with novel treatments, such as medications or devices, and the inclusion criteria that patients need to meet in order to qualify for the study. We then immediately jump into working with the providers, looking closely at the science and comparing the treatments to what is on the market already.” From there, Lisa coordinates conversations between the providers, sponsors and study teams to gauge everyone’s capacity based on the length of the study, ensuring everyone involved has the time to dedicate to the process. Next, the providers identify patients that meet the criteria for the study, and together, the team decides where the patient visits will happen and discusses any potential barriers that may affect patient retention. The budget is clearly defined at this stage, set up to make sure no patient is ever billed for medical costs incurred as a result of the study. Often, research participants are seen within the specialty clinics throughout the health system, while other times the Clinical Research Coordinators see patients at the recently centralized Clinical Research Office at Renown Regional Medical Center. This location provides an essential public-facing space for the community to learn more about clinical trials and demonstrates the breadth of resources available at Renown to sponsors to strengthen external partnerships and research funding opportunities. Once the study officially begins, team members like Lisa will set patients up for a “screening/qualifying visit.” During this appointment, she makes sure patients get scheduled for their lab work, imaging scans and anything else the provider may need to make an executive decision on whether or not the patient is a good candidate for the study. “I build it all in Epic,” said Lisa. “The study information, directions, requirements and next steps are all loaded in Epic for easy tracking. We are also required to input any notes in the sponsor’s electronic data capture website. All the information I track is inputted without protected health information (PHI), so every patient is completely anonymous.” After the patient officially qualifies, the study goes full steam ahead. Team members like Lisa and the providers receive continual updates from sponsors on the status of the study. “Throughout the entire process, I make sure patients get scheduled for everything that meets the requirements for the study,” said Lisa. “I meet with patients one-on-one to discuss their needs and concerns and ask questions about the study, organize their appointments and charts and deal with any issues or pivots that may arise. It’s very important that every patient fully understands what is going to happen with their care.” The Clinical Research department strives to serve as a care partner to patients, providers and clinics they work with. The majority of our Clinical Research Coordinators are trained phlebotomists and medical assistants, performing their own assessments such as lab draws and electrocardiograms (ECGs) to streamline the research visit process and reduce resource constraints on the clinics and health system. Lisa typically sees a couple of patients per week, depending on the study and where patients are in the cycle. Depending on the complexity of the trial, patients may see the research team only one time or several times over many years. Typically, clinical trial patients are seen in clinic every 2-4 weeks. There are many tasks required before, during and after a research visit to ensure everything runs smoothly, so Clinical Research Coordinators dedicate an average of 5-11 hours of work per patient, per visit. Regardless of patient load, each employee in the Clinical Research department – as well as participating teams across Renown and UNR Med – always step in to help each other out. According to Lisa, the environment is immensely supportive. “We have a program here at Renown to train employees who have never done clinical trials,” said Lisa. “We love seeing people get more engaged with the important work we do, and every department has been great at collaborating with us. Everyone brings a different perspective.” At the end of the study, Lisa gathers all the information and collects notes into a zip drive or paper binder for archiving. The sponsor lets the Clinical Research team, providers and patients know whether they are on the trial drug or on the placebo. The teams use the data gathered during the study to publish a report or present at conferences, promoting the critical research done to better the lives of patients in our community, and potentially, the world. “I appreciate the time everyone gives us to make sure our research is successful,” said Lisa. “It feels great to work together to make a difference, improve healthcare quality and save lives.” Behind-the-Scenes, Yet on the Frontlines The impact of research studies transcends hospital walls, and this can all be attributed to the dedication of our Clinical Research department. The constant collaboration between this team, lab science, medical assistants and providers, cardiology technologists, sonographers, finance teams and our partners at UNR Med is crucial to safeguarding the success of the studies. Devoted to keeping research close to home, Renown and UNR Med teamed up to form the Clinical Research Office (CRO) in 2021. With the strength of northern Nevada's largest not-for-profit health system and Nevada’s first medical school, this team is dedicated to giving our community access to the latest care innovations. “At UNR Med, we are working with students, residents and academic faculty; on the Renown side, we are working with clinicians and community participants,” said Amber Emerson, Manager for Community Outreach and Research Engagement for UNR Med. “Everything we do is data-driven,” added Kristen Gurnea, Manager of Clinical Research for Renown. “Our main goal is to optimize our impact and provide a community benefit for our patients. The scope of our roles in the Clinical Research office is very diverse.” To help meet the growing need locally for healthcare and cutting-edge treatment solutions, the CRO has continued to grow, expanding its research capabilities and helping bring new medications, medical devices and more to patients across northern Nevada and northeastern California. “Once upon a time, our team had only six members; today we have grown to a team of 25,” added Diana Torres, Research Resource Analyst for Renown. “We used to be considered one department, including Medical Education, and we have since branched off into our own cost center. We branched off even further and created a separate Genetics department that runs the Healthy Nevada Project. Throughout this process, the Clinical Research department was always the main point of the umbrella.” “We participate in hospital-wide outreach and marketing, and we feel this has really helped us get the word out about our department,” added Raul Arellano, Research Resource Analyst for Renown. “In fact, we doubled our clinical trial portfolio from last year.” The CRO currently operates over 100 clinical trials locally in cardiology, endocrinology, infectious disease, neurology, pediatric and adult oncology, pediatric sub-specialties and pulmonology. Behind the curtains of in-person research, the CRO is home to several experts who help turn our research studies into a reality, from budgeting and billing to barrier-breaking and building relationships. “I help with barriers patients and Clinical Research Coordinators are facing, building connections and relationships inside and outside of our health system,” said Kristen Gurnea. “I enjoy handling all the supporting pieces that are required for studies to happen.” “My role changes every day,” added Jenna Berger, Administrative Assistant for the CRO at Renown. “Some days, I’ll be helping coordinate patient stipends and going through document management to ensure we have all necessary signatures. Other days, I will be planning events – like Clinical Trials Week – for our department and creating marketing materials and fliers.” “Our day-to-day involves going over anything related to research financials,” added Diana Torres. “We handle sponsor billings, process efficiency and collecting revenue for research contracts, and we collaborate closely with our Finance department and Revenue Integrity in order to accomplish this. It’s important for us to make sure all billing on both the sponsor and patient side is taken care of, especially because patients should never receive a bill for medical services they receive for the trial. A year and a half ago, we started doing budget negotiations for research contracts,” said Diana Torres. “We are proud to help clinical teams with any training they may need on these negotiations as well as billing reviews and allocations.” Seeing patients progress during a study and transform before their eyes inspires the CRO team to continue doing what they do every day. “I’ve been here for many years, first working on the floor as an oncology nurse and transitioning to oncology research in 2005,” said Anna Winchell, Cancer Protocol Nurse for Renown. “I love getting to know the patients and seeing them progress into a healthy lifestyle.” Medical students and residents at UNR Med also play a significant role in the research process, advancing medicine by exploring causes and novel treatments for a wide range of conditions, including HIV, muscular dystrophy, gastrointestinal disorders, infectious diseases and more. Medical research at UNR Med is headed by committed research coordinators, community outreach managers, grants managers, pharmacists and physicians. “I oversee scientific review and help the physicians that come to us for those resources,” said Amil Trujillo-King, Medical Research Coordinator at UNR Med. “I guide medical students in their research protocols and help with different projects to improve research activities for both students and medical residents.” It takes a village to make clinical research happen. Because of that, the ACRO cannot thank the following teams enough for moving mountains for the future of medicine: Renown Health and UNR Med leadership for demonstrating the integrated health system’s commitment to expanding access to clinical research in our community within both the Renown / UNR Med affiliation and Renown active strategic plans. Renown Pharmacy especially Research Clinical Pharmacist Tim Morton, who supports all clinical trial medication dispensing and patient education across all clinical trials at Renown. Accounts Payable for having a huge impact on patient and employee reimbursement. Renown Medical Group for their participating providers, especially in oncology, cardiology, pulmonology, pediatrics, endocrinology and neurology, who are involved in research year after year. Marketing and Communications for helping with printed materials and raising awareness for clinical research at Renown and UNR Med. An Affiliation to Last Through the Ages A collective, shared vision of exploring community health – that is the impetus behind the affiliation between Renown and UNR Med. By leveraging resources across both institutions, the CRO has maximized their impact, giving the people of northern Nevada greater access to new interventions and treatments and promoting an impassioned culture with patients, providers, residents and medical students. “Community-based research always sat well with me,” said Amber Emerson. “As Renown and UNR Med, we have this unique opportunity to shape clinical research here in northern Nevada. We always make sure we present research in a meaningful way that speaks to the work we produce and demonstrates the opportunities we offer. After all, participating in clinical research doesn’t mean our patients are ‘guinea pigs’ – quite the opposite! They are partners in their health care, and we support them through providing access to novel treatments.” “Research is my passion, and my career has spanned broadly from grants administration to study coordination,” added Valerie Smith, Clinical Research Center Administrative Manager at UNR Med. “I am excited to be at the forefront of research frontiers in northern Nevada.” Through robust engagement and collaboration with healthcare providers, department administrators, internal research team members and leadership, the strength of this affiliation is unmeasurable. The CRO’s ultimate goal is to have clinical trials be the standard of care for every condition that Renown and UNR Med treats. Clinical research participation is all about patient autonomy, shared decision-making between patients and their providers and advancing medicine to save lives. From their beginnings as a small group of passionate researchers to their present reality as a leader in the research space in northern Nevada, their efforts do not go unnoticed. “The success of our department is inspiring,” said Amil Trujillo-King. “Renown and UNR Med supports the wellbeing of all employees and contributes directly to the growth of the department.” “When I first joined Renown in Patient Access, I didn’t realize that we had a research department; with a strong healthcare background in my family, I knew I wanted to grow in my career, and our expanding Clinical Research office was that next step,” said Raul Arellano. “With our affiliation with UNR Med, it’s especially inspiring to be able to apply what I learned as a Patient Access Representative to help further outcomes for our patients through managing our finances.” Through their unwavering commitment to research excellence and patient-centered care, the CRO will continue to pave the way for groundbreaking medical discoveries and improved outcomes for patients for years to come. “Fundamentally, we’re working to build a culture of research in our community because we believe it is the right thing to do. Our community deserves to have access to clinical trials and novel care close to home with a dedicated team to support them every step of the way,” closes Kristen Gurnea.
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Ovarian Cancer Survivor Shares Decision to Try Clinical Trial
While there used to be three basic treatment options for cancer -- surgery, radiation and chemotherapy, or a combination of the three -- there's a fourth option: clinical trials. Here, a Renown patient shares her successful battle with ovarian cancer, aided by a clinical trial. Shari Flamm's battle with ovarian cancer began in 2011. She was experiencing prolonged bleeding, irregular thyroid levels and anemia and was scheduled to undergo a hysterectomy. Before the surgery, her gynecologist ran routine tests to check for cancer as a precautionary measure. All tests were negative for cancer, expect her CA 125 test. A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in the blood. In some cases, a CA 125 test may be used to look for early signs of ovarian cancer in women with a very high risk of the disease. In most laboratories, the normal level is 0 to 35 units/ml. Flamm's CA 125 level was 121. As Flamm can attest, early diagnosis played a key role in her battle with ovarian cancer. September is Gynecologic Cancer and Ovarian Cancer Awareness Month – an important time to learn the signs, symptoms and risk factors of this type of cancer so your doctor can diagnosis the disease as early as possible. Ovarian Cancer: Round One Despite the elevated CA 125 results, her doctor recommended they move forward with the hysterectomy. But when surgery began, doctors discovered a mass. She had stage 4 cancer. The procedure was halted, the mass was biopsied and she was immediately seen by Dr. Peter Lim of the The Center of Hope. Following diagnosis, Flamm underwent surgery with Dr. Lim to remove the cancer, which had spread to part of diaphragm, spleen, colon and other organs. Three months after surgery, Flamm had recovered enough to start six rounds of chemotherapy in her hometown of Carson City. She continued working at a doctor's office during her treatment, and was grateful for Dr. Lim’s ability to co-manage her care so she could stay close to work and family. “To me, chemo was the scariest part because I didn’t like feeling sick,” Flamm says. Thankfully, her body responded well to the treatments and she was back to the things she loved. “I stated working out at the gym, even if it was only for 10 minutes,” she says. She also stayed positive by spending time with her grandchildren, attending a San Jose Sharks hockey game, going for walks and enjoying concerts. Ovarian Cancer: Round Two In November 2014, Flamm had a cancer check-up. That’s when doctors discovered three cancerous tumors. For this round, Flamm choose another treatment option -- clinical trials at Renown Institute for Cancer. Clinical trials are the studies that test whether drugs work, and inform doctors' decisions about how to treat their patients. Flamm participated in a clinical trial that featured oral-targeted therapy stronger than IV chemotherapy. The hope was for the drug to shrink her tumors, however the result was stabilization -- meaning the lumps weren’t growing or spreading. The best part of the clinical trial, Flamm says, was the constant monitoring. Between the CT scans every six weeks, a heart scan every three months and monthly doctor visits, she was confident that if the cancer started growing or spreading, her healthcare team would catch it right away. For Flamm, the benefits of the clinical trial included less hair loss, less fatigue and more time to focus on what’s important in her life -- her family. “I decided I wasn’t going to be that sick grandma on the couch with cancer,” Flamm says. After taking the oral medication for one year, Flamm developed a rash and discontinued treatment due to discomfort. Clinical Trials, Setbacks and Survival In June 2016, two of the three tumors began to grow and had to be surgically removed. Despite the setback, Flamm was determined to maintain a positive outlook. "You have to stay positive because cancer feeds off anger, depression and stress," Flamm says. Flamm was released to go home with clear margins, meaning the tumors were removed and are surrounded by a rim of normal tissue that does not have cancerous cells. Flamm says her outlook on life has changed drastically since her first cancer diagnosis. “Your whole mentality changes when cancer disturbs your life," Flann says. "The things that weren’t important, are now ever so important. I’m a lot calmer now,” Flamm says.
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How the UNR Med Affiliation Impacts Renown's Clinical Research
The University of Nevada, Reno School of Medicine (UNR Med) and Renown Health affiliated in June of 2021. First Integrated Health System The University of Nevada, Reno School of Medicine (UNR Med) and Renown Health affiliated in June of 2021. This agreement established Nevada’s first integrated health system with missions in education, patient care, and clinical research. While there was extensive media coverage regarding the historic partnership in general, there is less information regarding the important impact to the community. In terms of clinical research, the potential benefits are endless. The School of Medicine has a very successful program in molecular bio sciences. That means they have a plethora of brilliant minds working on the smallest components of life related to body systems and disease. With the affiliation, there is a distinct opportunity to bridge some of these important findings happening on campus and translate them into care protocols for the patients seen in the community. Making connections between the cellular basics to the physical manifestations of conditions is a key opportunity of the affiliation. Additionally, cooperative funding models for projects that fit in the translational research bucket are available to these researchers. Renown and UNR Med are poised to provide potentially cutting-edge treatments with bench to bedside research. Expanding Clinical Trials Perhaps the most important outcome of the affiliation is access to novel treatments via clinical trials. In the coming years, Renown and UNR Med will work to expand their clinical trial portfolio in an effort to provide a clinical trial option for many diseases in addition to standard of care. This endeavor will allow patients to make an informed choice about their healthcare. With novel treatments available right here in Reno, people won’t have to travel to other research institutions for similar care. This eases a tremendous potential burden on patients and families alike navigating complex illnesses like cancer. The affiliation is exciting and provides many opportunities for clinicians (present and future) and the community. Renown's Clinical Research Office is thrilled to be a part of this historic time and are enthusiastic to communicate our successes and opportunities to the community. We sincerely look forward to contributing to the vision of “a healthy Nevada.”
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Multiple Sclerosis Research Opportunities in Northern Nevada
There are nearly 1 million adults living with MS in the United States alone. For comparison, that is roughly the entire population of the Reno/Sparks and Las Vegas areas combined. MS is a neurological autoimmune condition which means that the immune system of patients with MS attacks the body’s myelin, a protective substance that covers your nerves. When this happens, the unprotected nerves can be damaged. Patients with MS may experience many different symptoms ranging from mild to severe, such as mobility and vision problems, fatigue and difficulty thinking. MS is usually diagnosed between the ages of 20-50, but late onset MS can occur in patients over 50 years old. While there is no cure for MS, there are effective treatments that can help reduce the burden of patients’ symptoms and create a positive quality of life. At Renown Health, we have joined the fight against MS through a partnership between advanced neurology programs and providers and our research office. We are proud to offer newly diagnosed MS patients the opportunity to choose between standard care treatment options or participating in an open label clinical trial, the AGNOS study. This study is assessing the impact of a new medication, ofatumumab, as the first disease modifying therapy participants receive for managing relapsing remitting MS, the most common form of MS.
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Managing Your Uncontrolled High Blood Pressure
Renown Health, the region's leading cardiology care provider, is offering a clinical trial for eligible patients struggling to control their high blood pressure. Nearly half of adults (119.9 million) in the United States have hypertension, or blood pressure that is higher than normal. Hypertension can put you at risk of other life-threatening disease, such as a heart attack or stroke. There are methods that cardiologists use to manage high blood pressure, but only 1 in 4 adults with hypertension (27.0 million) have their blood pressure under control.* Some patients with high blood pressure experience resistant hypertension, which does not respond well to multiple antihypertensive medications given at the same time. This means that there are many important opportunities for healthcare professionals to explore new ways to treat hypertension. At Renown Health, we lead the region in cardiology care with our technological expertise and patient-centered approach. That is why our cardiology team is partnering with the Renown Research Office to offer the RADIANCE Continued Access Protocol (RADIENCE CAP) clinical trial to eligible patients. RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in patients with uncontrolled hypertension despite the prescription of antihypertensive medications. The body’s complex communication system between the brain, heart and kidneys can sometimes become overactive, increasing your blood pressure through messages in the nervous system. Renal denervation is a minimally-invasive procedure which reduces activity from the nerves in your kidneys to lower blood pressure. This is the third in a series of renal denervation clinical trials Renown Health has offered to patients with resistant hypertension over the last several years, with over 40 local participants. “All the participants that I have had the pleasure to work with on these studies are very excited and grateful to have this option for helping control their blood pressure” states Lisa English, Lead Clinical Research Coordinator for Cardiology studies at Renown Health. “I love getting to know each one of them and helping on their healthcare journey. We have an amazing team of providers and staff at Renown that go out of their way to make patients experiences positive and the studies successful.” Dr. Michael Bloch, Cardiologist and Principal Investigator for the RADIANCE CAP study at Renown Health’s Institute for Heart and Vascular Health adds, “Despite lifestyle modifications like diet and exercise and the widespread availability of effective and well-tolerated medications, approximately 50% of all people with hypertension have inadequate blood pressure control putting them at risk for stroke, heart failure and kidney disease. As a one-time durable procedure, renal denervation with the Paradise endovascular system from ReCor Medical, Inc. may help millions of patients improve their blood pressure control without necessarily needing to increase their medications.” Our teams of expert providers and researchers are here to support you on your healthcare journey. Talk to your provider about the RADIANCE CAP clinical trial at your next appointment to see if participation may be right for you.
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