Clinical trials have long been criticized on the basis of their lack of racial diversity or impracticality for potential subjects (see: 2016: The Year of Diversity in Clinical Trials). This has resulted in the call for the "democratization" of trials (see: TrialReach And The Democratization Of Clinical Trials). Here's an excerpt from an FDA article about the challenge of reaching a broad swath of subjects for clinical trials (see: 2016: The Year of Diversity in Clinical Trials):
Controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains for FDA is ensuring that research participants are representative of the patients who will use the medical product. Moving from the result of a clinical trial to applying it in practice is complex. But it’s generally agreed that the composition of the population enrolled in a trial should help FDA reviewers, clinicians, or policy makers to have confidence that the trial results will apply to future practice. Furthermore, a wide range of people should have the opportunity to participate in trials, both for access to new therapies and to have the chance to contribute to better treatment of everyone, an important altruistic goal for many Americans.
I came across a recent article that discussed how the Center Point Clinical Services, a contract research organization [CRO], has launched a series of "site-less" trials (see: Site-Less Clinical Trial Depends On Pharmacists' Relationships With Patients). Below is an excerpt from it:
[R]ecruitment relies on the Center Point Clinical Trial Research Pharmacists (CTRP), who know a study’s inclusion and exclusion criteria and can share it with potential patients....Center Point also filters health records through a HIPPA-compliant collaboration with pharmacies and health systems. Site-less trials only recruit for one site instead of multiple; they operate remotely but coordinate with health care teams according to trial protocol....“Patients will often see multiple doctors,” says ...[a company spokesperson], “but will stick with one pharmacist, who usually knows his or her patients very well.” Information from wearable devices goes immediately into the cloud and then the study’s database. All information is confidential. ...[He] attributes these patient-pharmacist relationships, emphasizing protocol, compliance, and compassion, for increasing patient engagement. The CTRP “are the glue that hold everything together,” he says.....Center Point became an LLC in 2014 and has performed up to 10 site-less studies...[T]his model is good for “80 – 90%” of trials but works particularly well for trials in which office visits are not needed or can be done remotely.
The basic idea behind site-less clinical trials is that subjects are remotely managed by a team of pharmacists working for the CRO and by sponsor clinical teams in lieu of the subjects being required to travel to a study site. Information from subjects' wearable devices goes immediately into the cloud and then the study’s database. Such health wearables are revolutionizing clinical trials by acquiring objective information such as subject physical activity (see: The Growing Availability of Wearable Devices: A Perspective on Current Applications in Clinical Trials). I would draw an analogy between telemedicine visits by a physician and the site-less clinical trials discussed here. Clearly, this new approach is not suitable to the more complex studies in which subjects need to be examined by a physician or imaging studies are frequently required. Nevertheless, I think that new idea is an interesting one and I look forward to reading more about it.