What Every Clinical Team Should Consider Before Developing The Next Protocol: Putting Volunteers First

Momentum continues to build around “patient centricity,” a concept that is captivating the biopharmaceutical industry and spawning everything from articles and conferences to surveys, webinars and lively LinkedIn exchanges. And while everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience without whom drug development would be impossible—clinical trial participants. For one thing, there is an important distinction between the two audiences, according to representatives of investigator sites, who operate on the front lines of clinical research. “Although individuals who participate in clinical trials are often referred to as patients, they really aren’t patients – they’re actually volunteers,” said Therese Dayton, RN, CCRC, Director of Nursing and Operations at Rochester Clinical Research (RCR) in Rochester, NY. “They volunteer their time and medical treatment during a trial which is not guaranteed,” she added, explaining, “Volunteers could receive a placebo or an unproven or ineffective treatment. That’s the whole point of research.” As a result, investigator sites eschew the phrase “patient centricity” in favor of “volunteer centricity”.

Only about 5% of those eligible to participate in trials actually do so, even though the number and size of studies have been escalating. Those who do volunteer to participate in trials can face some frustrating experiences, thanks to what could be characterized as a combination of faulty communication and protocol missteps. Among them: hard-to-open drug packaging, unclear directions about following complex regimens, an escalating number of required medical procedures, malfunctioning technology, and clinic appointments that must be cancelled—again—when supplies fail to arrive.

The issues may be a consequence of a failure to consider the needs of volunteers during the protocol development process. Beyond engendering frustration among volunteers and the site staff who interact with them, such issues potentially endanger drug development by eroding the three cornerstones of clinical research—adherence, retention and recruitment. At a time when companies are readily embracing new opportunities to engage patients, they would do well to dismantle barriers to clinical trial participation by making subjects the centerpiece of the protocol planning process. “Volunteer-centric” trials engage subjects as partners in clinical research by making participation easy, positive and comfortable experiences for them. Doing so has the potential to launch a new era of volunteer-centric clinical trials that, aside from being efficient and cost-effective, establish a cadre of research ambassadors—volunteers whose experiences are so fulfilling that they join additional studies and encourage friends and family to do the same.

Read this whitepaper to learn why even though everyone applauds the renewed focus on patients as a positive development, some say it is time for biopharma companies to turn their attention to another audience without whom drug development would be impossible—clinical trial participants.