Globally, it is common for pharma companies to have trouble recruiting and retaining patients for clinical trials. It has long been known that patients choose not to take part for many reasons including lack of information and guidance, or cumbersome participation requirements. To illustrate these difficulties, a recent estimate suggests that only 4% of patients with certain oncological diagnoses participate in clinical trials. As we have discussed, some believe that patient engagement is the answer to the problems faced in patient participation. But what does this really mean?
Stakeholders involved in making clinical trials “patient centric” have long used the “trial-and-error” approach. The research industry has experienced trends that work to leverage innovative solutions to improve trial experiences for patients, sometimes with farcical results. Such experiments fail for a couple of reasons;
1) There is no clear understanding of what the problem is
2) There is no clear “silver bullet” that applies to trials universally across geographies, time and indications
Regarding the first one, surveys unequivocally prove the main patient concerns regarding participation in clinical studies. In what should surprise no-one, most patients fear safety/side effects, expenses associated with the trial, participation requirements and getting a placebo. Most patient concerns could be solved with enhanced information and education, which unfortunately leads to the second point: there is no silver bullet. Each trial is different and, while information and education are key to drive patient engagement, delivering on each differs from one study to the next. One approach that experts reliably agree yields positive results is to have consistent human involvement with prospective and current patients.
So how do we ensure the adequate level of human interaction in the clinical trials? Some sponsors have created “patient engagement specialist” positions to provide training and tools to inform and guide patients through their study journeys. Furthermore, some companies communicate with patient groups during protocol design to help sponsors realize common pitfalls and design errors that may cause trial failures. These approaches allow patients to voice their concerns and see them legitimately reflected in the protocol, helping drive trust, recruitment and retention.
In the UK, the National Institute for Health Research (NIHR) has managed to drive patient participation in clinical trials by 260%. While it is impossible to replicate this success due to clear differences in healthcare systems, it is important to understand that engagement consistently produces positive results. These exercises create trust between stakeholders and help patients see themselves as critical components to the success of the trial.
Keith Wilson, patient research ambassador from the NHS, explains “patients and the public can be a real asset to life science companies. We have a very different view than clinicians and scientists, so we can spot the challenges to study recruitment and retention, and often the solutions, that companies sometimes miss.”
To learn more about this topic, please visit #HumanBehindEveryNumber, our recently launched NGO that works showcase patient voices in the design and execution of clinical trials.
Associate Director, PR & Marketing
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