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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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There are many misconceptions about clinical research, so we have unpacked a few common myths we hear to help you make an informed decision in your healthcare. Misconception #1: If I join a clinical trial, I’ll just be a guinea pig. Quite the opposite is true! Through honest and respectful conversation, we ensure all participants are informed of the benefits and risks associated with the clinical trial during the informed consent process. Being in a clinical trial is voluntary, and we respect our patients’ decision to join or decline to participate in the clinical trial. You can always change your mind at any time as well. When patients join a clinical trial, they receive an additional team of healthcare professionals, including additional physicians, pharmacists and research coordinators, dedicated to their safety and well-being. This means that clinical trial participants often receive more support than they would in the standard treatment setting. Misconception #2: Clinical trials are too dangerous because they use new treatments that haven’t been tested. We recognize that there are different levels of risk associated with participating in a clinical trial depending on the type of study. However, new treatments are only reviewed through clinical trials after they have gone through extensive testing. New treatments that do not show promising results for safety and potential benefit during laboratory testing do not receive approval to begin clinical trials. Your research team reviews any expected benefits and risks identified from previous studies during the informed consent process, as well as any updates that occur throughout the duration of the clinical trial. The research team stays in close contact with you during the entire process, documenting and treating any side effects that you experience for both your safety and the safety of participants like you. Misconception #3: I don't want to join a trial because I could be wasting my time receiving a placebo. A placebo is a substance that has no therapeutic effect, sometimes called a “sugar pill.” Participants who receive a placebo during a clinical trial are very important, helping researchers definitively determine the specific good and bad effects of the new medication. Many clinical trials that involve a placebo also offer what is called an open label extension or cross-over study. Cross-over studies ensure that anyone taking the placebo can begin receiving the new medication, often for several years. Cross-over studies help clinician researchers understand the long-term effects of a medication while also giving patients free access to novel care for several months and even years.

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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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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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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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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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