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The transformation in patient perceptions will only happen when the five million Americans who’ve already participated in clinical trials can directly share their experiences with the next five million people considering participating.
As a clinical researcher, cardiologist, and technologist, I want to commend the groundbreaking work of Dr. Martin’s MyStudies team, the FDA Catalyst team for providing the necessary data framework, and Health and Human Services (HHS) for the support of the project as covered in David Martin’s article “MyStudies Platform Brings Patient Experience to Drug Development.” Above all, the FDA’s Patient EngageÂment Advisory Council-comprised of actual patients-deserves specific credit for bringing the patient voice into the design thinking for technologies in clinical research. This important and empowering project is very much a sign of the frame shift that is now upon us guiding how patients evaluate and engage clinical trials.
In this project, we can also take encouragement from the clear validation by FDA of mobile input as a reasonable and appropriate media for collecÂtion of patient feedback in clinical trials-an apÂproach that maximizes collection opportunity and minimizes patient burden. Surely this is the path forward to making the collection ePRO and eCOA as streamlined as possible-as noted by recent advances from Medidata and others.
And in reviewing the MyStudies capabilities and functionality, additional opportunities to fully capture patient voice present themselves. As Craig Lipset, until recently Pfizer’s head of clinical inÂnovation, has observed, “There are two flavors to patient experience data-the first flavor includes FDA initiatives like MyStudies as well as patient-focused drug development (PFDD) that focus on the experience of patients with a specific medical condition or the patient experience while using a medication. These are natural and modern extenÂsions of patient-reported outcomes (PROs).”
Lipset goes on to draw a distinction between this data set and the experience data of participaÂtion in clinical research itself. “Concurrently, reÂsearch sponsors are concerned with the subjecÂtive experience of patients within clinical research studies. This flavor is an extension of sponsor initiatives themed around patient centricity and patient engagement.”
Today, this second patient experience data set-which would simply ask, “What is it like to participate in a clinical trial? Would you recomÂmend it to a friend or family?”-is the last unÂtapped data space that could radically transform clinical trial development and execution.
And unlike our current propensity to collect and then sequester data from patients, this second patient experience data set would do its greatest good for the greatest number of people if it was patient-facing and transparent from inception.
What would be some components of such an approach to capturing this deeper, more generÂalizable patient experience? As noted, it would start by being patient-facing and delivering a more user intent-oriented search experience than our current best options, like the compreÂhensive but often overwhelming clinicaltrials.gov. In other words, it would answer the questions that patients already ask as consumers, “what should I do?” and “what do people like me think about this option?”
While we get this information shopping for shoes, cars, and even doctors, there is no equivalent for evaluating clinical research as a care option. The patient-as-consumer alÂready has a framework in mind for online supÂport-from Amazon to Healthgrades-and that is peer-to-peer education and support in the form of ratings and reviews. The transformaÂtion we all hope for in patient perceptions of clinical research, ranging from concerns of plaÂcebo, guinea pigs, and Tuskegee, is not going to happen as a result of greater data downloads or white papers. It will only happen when the approximately five million Americans who’ve already participated in clinical trials can directly share their experiences with the next five milÂlion people considering participating-in a way that is easily digested and resonates.
As we celebrate the work of the MyStudies team and address the patient experience transÂformation upon us, it is exciting to realize we’re at the beginning of the next great opportunity to enhance how we bring new medicines to market.
Irfan Khan, CEO, Circuit Clinical