THE VALUE OF ENGAGING SITES IN CLINICAL TRIAL DEVELOPMENT
Vivienne Van de Walle, Co-Founder of PT&R – a dedicated clinical trial site in the Netherlands, and Chris Porter, VP of Marketing & Digital Strategy, ERT, explore how involving clinical sites early on in the trial process can help simplify the study for sites, help sponsors avoid common, yet important, pitfalls and accelerate clinical trial timelines.
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Vivienne Van de Walle, Co-Founder of PT&R – a dedicated clinical trial site in the Netherlands, is joined by Chris Porter, VP of Marketing & Digital Strategy, ERT for a discussion about the importance of involving clinical sites in the design of studies. Sites are on the frontline of your clinical trials and as such, bring with them a wealth of experience and advice on how to make trials run more smoothly and efficiently, ultimately bringing drugs to market faster. Here’s a summary of what you can expect from the podcast:
The Value of Your Sites Embracing Technology
Paper data collection is still used in clinical studies. Learn how a site views the importance of embracing technology to get drugs to the patients who need them, faster.
Simplify Site Staff’s Day-to-Day Lives
Keeping sites engaged in clinical trials is vital. If sites are motivated, they will be high recruiters, help achieve high compliance rates amongst patients and give you the data you need to make your trial a success. To do this, we need to make taking part as simple as possible. Eliminate multiple portals with multiple logins, ensure automatic notifications to site staff are part of the protocol to capture patients who are non-compliant and ensure training requirements are kept to a minimum.
Involve Sites Early in Your Study Design
Sites spot problems which sponsors, CRO’s and vendors may miss. For example, is the device actually intuitive to use? If not, patients are likely to be non-compliant. Asking patients with specific neurological conditions to use a stylus to record electronic diary entries may prove problematic and might result in the failure of the entire trial. These kinds of details may be overlooked by anyone but the site, yet are vital for the success of the trial itself.
Viviënne van de Walle studied medicine both at the University of Maastricht and at the University of Oxford. In 2004 she successfully defended her thesis for her Ph.D. and in 2011, she passed the CPI exam. She has always combined clinical research with patient care and has been a full-time investigator at independent clinical research sites. She co-founded and owns the independent research site PT&R (www.ptr.nu) since 2006. Her entrepreneurship is reflected by her skills as a thought leader and in consulting, education, management, and executive functions at CROs, pharma and trade organizations i.e. ACRP, SCRS, TransCelerate, and NVFG. With her PT&R-team she was also the proud winner of the inaugural SPRIA EU. She started her research career as a participant in a clinical trial. As a result, Vivienne has a unique perspective of the various sides of the table in clinical research and is eager to share her many years of experience.