Unraveling Hybrid Clinical Trials: Challenges And Opportunities

Hybrid trials — in which patients participate from home for some visits/activities, rather than in a clinical setting — have undergone rapid evolution in the past few years. Conceived more than a decade ago and thrust into prominence during the COVID-19 pandemic, hybrid clinical trials now have become the rule, rather than the exception. Sponsors and their partners progress further every day into more effective implementation of decentralized methodologies, supporting technologies, and other tools to promote the generation of more accurate data and streamline regulatory review, as well as reduce investigator and patient burdens.

This E-Book examines how hybrid trials’ journey has taken place in recent years — the reasons for confidence and concern — and examines how hybrid trials may impact pharmaceutical development in the future. “Warming Up To Hybrid Trials” (pages 5-7) looks at the industry’s effort to make accommodations that would enable clinical trials to continue while maintaining patient safety, with respect to both the trials themselves and COVID. Over the course of one year — seemingly overnight, in an industry not known for rapid change — the use of hybrid trial methods and technologies, as well as the industry’s understanding of hybrid trial advantages and challenge areas relevant to various therapy areas, skyrocketed.

Throughout 2021, ISR produced a series of reports digging deep into the rise of hybrid trials, a trio of which are included in this e-book. “Interest In Hybrid Trials Increases” (page 8) tracks the aforementioned sharp rise in hybrid trial utilization, as well as optimism for the use of hybrid trials in greater proportion to traditional trials moving forward. “Managing Trial Components: Hybrid Vs. Traditional Models” (page 9) asked respondents to weigh in regarding whether the management of a variety of trial functions was made easier in a hybrid model, in a traditional model, or whether no appreciable difference existed.

“Hybrid Trials Are Impacting Clinical Research, But Do Patients Want Them?” (pages 10-11) features a discussion with Ken Getz, founder of The Center for Information and Study on Clinical Research Participation (CISCRP), which has spent nearly a decade focusing on the patient experience in clinical trials via its Perceptions and Insights study. It examines what is necessary to sustain hybrid methodologies. Meanwhile, “Hybrid Vs. Traditional Clinical Trial Costs” (page 12) analyzes each trial approach’s perceived expense relative to the other, both now and in the future.

“Hybrid Trials Q&A” (pages 13-15), features a sit down with Rebecca McAvoy, VP of market research at ISR Reports. The Q&A discusses key takeaways from a recent ISR report (Hybrid/Virtual/Decentralized Clinical Trials Market Outlook), as well as seeks additional insight from Rebecca. The e-book concludes with “Hybrid Trials Are Here To Stay” (pages 16-19), which acknowledges the speed at which hybrid trials came to dominate clinical research, gauges respondents’ thoughts on the effectiveness of those trials, and speculates on hybrid elements that have improved over time or remain to be ameliorated.

Hybrid trials have become so common on the clinical trial landscape that it almost is difficult to remember a time when they were not so ubiquitous, even though it was only a few years ago. The industry can continue to improve the effectiveness of hybrid trials by recognizing the pressures that have led to a de facto “coming out party” for hybridized studies since 2020, understanding associated difficulties that have been overcome so far, and comprehending the challenges yet to be conquered.