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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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Could Private Well Water Unlock Health Insights?
The Healthy NV Project® launches a new study to identify how private well water could impact the health of those living in the household. You use your faucet to wash your hands, make coffee and fill your water bottle. However, for approximately 41,000 people in Washoe and Churchill Counties who rely on private well water, there may be unseen contaminants present in their H2O, which could be affecting their health. The Healthy Nevada Project®, with support from the National Institutes of Health (NIH), is launching a new study to discover how private well water quality impacts the health of well owners. By providing free water testing kits to interested Healthy Nevada Project® participants, researchers will collect samples and give results back to well owners, along with resources for potential treatment options. Data from previous studies in Nevada show elevated concentrations of heavy metals in some private, household wells. Since water from household wells is not monitored for quality by government agencies, well water testing helps ensure water does not contain dangerous levels of heavy metals, such as lead, which can lead to adverse health impacts. Those with a household well interested in receiving a free water testing kit must be enrolled in the Healthy Nevada Project’s population genetic screening study and consent to be a part of further research. People interested in joining the study can simply sign up to receive a genetic spit test kit in the mail or join the waitlist to be notified when in-person testing resumes. “The goals of the Healthy Nevada project are to improve population health and better understand processes that increase disease risks, such as cancer. In this study, we engage with our study participants and inform them about the impact of the environment on their health, while researching environmental contaminants that may elevate cancer risk,” said Joseph Grzymski, Ph.D., research professor at DRI, principal investigator of the Healthy Nevada Project® and chief scientific officer for Renown Health. “During a time where people are spending more time at home, we’re excited to launch this multi-disciplinary study that dives into possible health impacts of a household’s water source.” “As the Healthy Nevada Project continues to serve over 54,000 research volunteers, we are proud to provide helpful information to participants, so they can make life-changing improvements to their home environment,” said Tony Slonim, M.D., DrPH, FACHE, president and CEO of Renown Health and co-director of the Healthy Nevada Project. “This allows every person with well water in Nevada, to have important information, at no charge, to help live healthier and better lives and to protect their family’s health.” The Healthy Nevada Project® is the fastest-enrolling genetic study in the country. The Project is also the first of its kind to return clinical results to study volunteers, which means participants can learn their genetic risks tied to heart disease and certain cancers, as well as lifestyle changes that could potentially help reduce their risk and prevent disease. To enroll in the Healthy Nevada Project, please visit healthynv.org. Renown Institute for Health Innovation is a collaboration between Renown Health - a locally governed and locally owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California; and the Desert Research Institute - a recognized world leader in investigating the effects of natural and human-induced environmental change and advancing technologies aimed at assessing a changing planet. Renown IHI research teams are focused on integrating personal healthcare and environmental data with socioeconomic determinants to help Nevada address some of its most complex environmental health problems; while simultaneously expanding the state’s access to leading-edge clinical trials and fostering new connections with biotechnology and pharmaceutical companies. Learn more at healthynv.org.
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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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Renown Institute Expands Partnership to Offer ELF Testing
Together, will test over 30,000 qualifying study participants by 2023 for risk of cirrhosis and liver-related illnesses. Renown Institute for Health Innovation (IHI) announced today that the organization and Gilead Sciences, Inc. will be joining forces with Siemens Healthineers to offer the Enhanced Liver Fibrosis (ELF™) Test to people with risks for nonalcoholic steatohepatitis (NASH) enrolled in the Healthy Nevada Project (HNP). The ELF Test will help identify people most at risk for progressing to cirrhosis and liver-related outcomes and allow healthcare providers to intervene before irreparable damage occurs. This noninvasive blood test uses three serum biomarkers to create an ELF score from a predefined algorithm, which can be used by doctors to help evaluate if a patient requires increased medical care and monitoring for their condition. Nonalcoholic fatty liver disease (NAFLD), which includes NASH, is prevalent in Nevada and under-diagnosed, likely affecting more than 500,000 adult Nevadans. If undetected and untreated, NASH can result in liver cirrhosis and may require liver transplantation or lead to death. There are more than 12,000 people on a waitlist for liver transplantation in the U.S. and this number continues to rise due to the increasing prevalence of NAFLD. “Thanks to important data collected through our Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study, we now know that NASH is prevalent in the state of Nevada,” said Tony Slonim, M.D., DrPH, FACHE, president and CEO of Renown Health. “We are proud to expand our partnership with Gilead and begin working with Siemens Healthineers to improve health of those with liver disease and to take early detection one step further by offering Enhanced Liver Fibrosis, ELF testing for patients of Renown Health. This test provides our team of highly-skilled physicians an advanced, noninvasive method to actively assess dynamic liver fibrosis in study participants and intervene whenever necessary, contributing to a healthier Nevada.” “Gilead believes that noninvasive tests, including the ELF Test, will help improve the experience of people living with NASH. These tests may help to diagnose liver disease, monitor disease progression and evaluate responses to treatment without the requirement for liver biopsy,” said Rob Myers, MD, Vice President, Liver Fibrosis Clinical Research at Gilead Sciences. “The ELF Test has proven itself to be a valuable tool in NASH management and we hope this partnership will further support its use in routine care.” “We are very pleased that NASH patients in the Healthy Nevada Project now have access to the ELF Test which offers clinically useful prognostic information for their condition with the convenience of a simple blood test. Using our advanced laboratory expertise together with Renown IHI and Gilead, we can work towards better understanding of NASH and liver disease in a representative patient population,” said Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers. “We launched the Healthy Nevada Project to help people understand more about their health, to identify serious health risks, and to give people access to innovations like the ELF Test, so they can live their best lives,” said Renown’s chief scientific officer, Dr. Joseph Grzymski, who is also a research professor at the Desert Research Institute and principal investigator of the Healthy Nevada Project. It’s incredibly rewarding to be able to report clinical findings to help our 50,000 volunteer study participants, and to assist healthcare providers in helping their patients.” The provision of the ELF Test builds on a previously announced strategic collaboration between the Renown IHI and Gilead in July 2019. This ongoing partnership aims to collect and analyze de-identified genetic and electronic health data from 60,000 qualifying study participants to enhance the understanding of NAFLD and NASH and to potentially inform development of treatment options for these diseases. About NAFLD and NASH NAFLD is a build-up of fat in the liver of people who do not have a history of alcohol misuse. It is normal for the liver to contain some fat, but if more than 5 percent of the liver content is fat, it’s considered a fatty liver (steatosis). NASH is the most severe form of NAFLD in which a person has liver cell damage and inflammation of the liver. Inflammation and liver cell damage can cause fibrosis, or scarring of the liver, and can cause decreased liver function (1). The symptoms of NASH are often silent or non-specific, making it difficult to diagnose. About one-third of people with NASH develop cirrhosis or irreversible liver damage (2). About the ELF™ Test The ELF Test is a noninvasive blood test that can quickly identify which patients are at an elevated risk for developing cirrhosis and other liver-related clinical events (LREs). In contrast to standard liver enzyme tests that reflect liver damage that has already occurred, the ELF Test combines three serum direct biomarkers of active fibrosis. The ELF Test algorithm measures each of these biomarkers to create an ELF score, which can be used as an aid to assess the risk for future disease progression. Doctors may use this ELF score to help evaluate if a patient requires increased medical care and monitoring for their condition. Individuals interested in determining their risk for NASH and its progression are encouraged to enroll in the Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study. Those who have already consented and participated in the study will be contacted with more information on how to receive an ELF blood test. For more information or to enroll, please contact RenownIHI@renown.org or (775) 982-6914. The Enhanced Liver Fibrosis (ELF™) Test kit is not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements. In the U.S., the ELF Testing Service is available from Siemens Healthcare Laboratory, LLC (SHL), a CLIA-certified laboratory located in Berkeley, Calif. The ELF Testing Service, including the establishment of performance characteristics, was developed by SHL. The ELF Test has not been cleared or approved by the U.S. Food and Drug Administration. SHL is regulated under CLIA as qualified to perform high complexity testing. The ELF Test is used for clinical purposes and should not be regarded as investigational use only or research use only. About Renown Health Renown Health is the region’s largest, locally owned and 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’s institute model addresses social determinants of health and includes: Child Health, Behavioral Health & Addiction, Healthy Aging and Health Innovation. Clinical institutes include: Cancer, Heart and Vascular Health, Neurosciences and Robotic Surgery. 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 the Renown Institute for Health Innovation Renown Institute for Health Innovation is a collaboration between Renown Health - a locally governed and locally owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California; and the Desert Research Institute - a recognized world leader in investigating the effects of natural and human-induced environmental change and advancing technologies aimed at assessing a changing planet. Renown IHI research teams are focused on integrating personal healthcare and environmental data with socioeconomic determinants to help Nevada address some of its most complex environmental health problems; while simultaneously expanding the state’s access to leading-edge clinical trials and fostering new connections with biotechnology and pharmaceutical companies. Learn more at healthynv.org. Renown Health is Nevada’s most comprehensive and integrated healthcare network and maintains electronic health records for 1.02 million registered patients. In 2016, Renown Health and the Desert Research Institute established the Healthy Nevada Project (HNP), the nation’s first community-based population health study. In 2017 HNP began a partnership with Helix to leverage its population health services, Exome+™ sequencing, and consumer engagement tools. The HNP is now an ongoing collaboration between Renown IHI, the Desert Research Institute, a global leader in environmental data and applied research, and Helix, a personal genomics company. HNP combines genetic, environmental, social and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The HNP currently has over 60,000 participants. For more information, visit healthynv.org. About Siemens Healthineers Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers, which has approximately 54,000 employees worldwide, generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Further information is available at www.siemens-healthineers.com.Media Contact for Siemens Healthineers: Lance LongwellM: 610-448-6341E: lance.longwell@siemens-healthineers.com
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