3 The hope is that such changes will also enhance the diversity of participants in clinical studies. These decentralized, or direct-to-participant, studies offer the promise of faster recruitment, improved retention, and greater control, convenience, comfort, and even confidentiality for study participants. Food and Drug Administration released a guidance in November 2020 that asks sponsors to “make trial participation less burdensome for participants.” 2 Decentralized studies that move research activities from an investigational site to a participant’s home are one important step to reducing that burden. To help change that orientation and to foster an inclusive approach to clinical trials, the U.S. The result is that many participants, who bear the disproportionate share of the burden and risk in clinical studies, feel invisible, uninformed, and inadequately recognized.īerwick critiqued health care as “physician-centric.” Current clinical research is investigator- or site-centric all activities orbit around the site not the participant. Often after the research is completed, participants are informed neither of their individual results nor of the study’s overall outcomes, even if harm from the intervention is identified. In many cases, they have little voice in the design or conduct of the research. They are also expected to take time off from work or other activities, travel to research centers (often with a partner or caregiver) at their own expense, undergo extensive and time-consuming assessments (some of which are uncomfortable or risky), and repeat the process several times over weeks, months, or years. For example, in clinical trials individuals bearing the burden of a disease are asked to take experimental therapies with known and unknown safety risks and uncertain efficacy. The demands and experiences of research “subjects” explain why. While most individuals want to participate in research, few do.
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