When Pfizer announced that it was conducting the first at-home clinical trial under an IND, I was initially skeptical, particularly with regard to issues of consent and safety. But over the last few weeks Craig Lipset of Pfizer has done an excellent job of answering questions in a variety of venues, effectively demonstrating the thoughtfulness of his approach to this project’s implementation.
Craig took the time to respond to questions in the comments section of Pharmalot‘s article on the subject, in addition to answering questions in a pharma social media chat on Twitter. Most recently, Craig responded to questions from Dan and Don of Clinical Trials Guru during an excellent interview.
But I still have one lingering question about the “trial in a box” concept that I have yet to see discussed.
In theory the at-home clinical trial model could improve recruitment and retention by opening up trials to a larger patient population and making trial participation more convenient. However, this approach may present substantial challenges for recruitment and retention as well.
Though the time commitment required for clinical trial participation is substantial, I’m not convinced that this commitment is as much of a deterrent as is often believed. In fact, the act of going to a study site and interacting with study staff may be a key component of good recruitment and retention.
The Role of Site Staff
Kenneth Getz of CISCRP did a focus group with study volunteers to learn about their experiences and perceptions of clinical trials.
Study volunteers readily and consistently affirm the essential role that study staff and health care professionals play in volunteer recruitment and retention. These professionals are the sole interface and the primary vehicle through which volunteers learn to trust, interact, and comply with clinical research…
Volunteers’ personal relationships with study staff greatly influence the decision to initiate and the willingness to complete participation. The overwhelming majority of conversation group participants praise the support system offered by the PI, coordinators, and administrative staff. For some, seemingly trivial actions—like a friendly face, a listening ear, and a level of concern that might have been lacking in their previous medical encounters—go far in engendering trust and the sense that volunteers are valued members of the research team.
My personal experience as a clinical research coordinator is consistent with the attitudes expressed by patients who participated in this focus group.
Though research sites are charged with the task of protocol implementation, site staff are far more than mere protocol automatons. They offer a support system, build volunteer trust, and help volunteers understand the value of their participation. And these contributions are an essential part of clinical research, as well as a key element of recruitment and retention.
In essence, the relationships between site staff and volunteers play a critical role in trial participation.
Can an At-Home Trials Facilitate Relationships?
So here’s my lingering question: Is the at-home clinical trial technology implemented in a manner that facilitates these important relationships between participants and study staff?
Though true face-to-face interaction can be a challenge to replicate with technology, I don’t buy the notion that interaction with technology need be cold and dehumanizing. It certainly can be, but it doesn’t have to be.
For example, I’ve had very enriching experiences with Twitter and other social media sites, which allowed me to develop meaningful relationships with people who I would not have otherwise met. But these are social media sites, so they are inherently, well, social.
A technology platform designed to deliver at-home clinical trials is not going to be naturally social in the way that social media sites are, so it will not be a platform conducive to building relationships. That is, unless social elements are carefully woven into the technology, allowing participants to experience the same human connection they get at a brick-and-mortar research site. Such an implementation seems like a challenging, though not impossible proposition.
New Clinical Trials Possibilities
I have much respect for the innovation being demonstrated by Craig Lipset and Pfizer. This industry is in dire need of fresh thinking, and it takes courage to take the risk, particularly in the face of common industry conservatism.
Several details of the “trial in a box” implementation are impressive, but one design decision is particularly wise. The platform for conducting these at-home clinical trials was developed as a series of modules. So regardless of whether this particular model is successful, Pfizer will have these modules which it can “plug in” to clinical trials as appropriate.
For example, Pfizer’s informed consent module can be used in other clinical trials to improve the informed consent process. Certainly, particular types of trials may not lend themselves to a virtual consenting process. But that’s the wisdom in this modular format. You only use the modules when they are appropriate for a particular trial.
Whatever the outcome of this at-home trial, the technology developed to support it will be a game-changer for the industry.
Thoughts? Don’t be shy. Put your input in the comments below.