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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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