Home Trial Support For DCTs: It's Not Just Patient-Centric, It's Good Business Centric

The application of decentralized clinical trial (DCT) technologies and techniques has revolutionized the way trials are conducted in general. However, some patient groups — including, but not limited to, pediatric, geriatric, Alzheimer’s, oncology, neurological, and/or rare disease patients — present additional challenges to sponsors in terms of the ability to provide high-quality care. These difficulties, in turn, can negatively impact patient recruitment and retention for both ongoing and future clinical trials.

It must be acknowledged that working with such patients requires careful consideration and accommodation, of the day-to-day challenges they face in living with their affliction, as well as the burdens placed on their families and other caregivers — before trial participation even is factored in. Viewed through that lens, home trial support (HTS) solutions should be implemented that ease trial participation on an individual basis, versus general application of a solution with the expectation it will benefit all patients equally. While this principle is applicable to any clinical trial, it is critical to meeting more challenging patient groups’ needs in a way that encourages continued trial participation.  

Better education and sharing of information, relevant to both patients and sponsors, is likely the easiest (i.e., low-cost, high-impact) improvement to apply to clinical trials serving challenging patient groups. Sponsors are experts in their drug, but they sometimes do not grasp the nuance and difficulty of running a clinical trial with such patients in a way that does not undermine the patients’ willingness to participate in the ongoing trial and future trials. This consideration is particularly important in rare disease trials, where the participant pool already is limited.