Improving the efficiency of trials using innovative pilot designs: the next phase in the conduct and reporting of pilot and feasibility studies

Abstract

With continuously increasing costs of conducting trials, use of innovative approaches—such as pragmatic trials, registry-based randomised trials, adaptive trials, personalised medicine trials, platform trials, and basket trials—to the design and conduct of clinical trials has been advocated as one of the most promising solutions. In this editorial, we propose that the next wave of feasibility or pilot studies should focus on assessing the feasibility of trials using these designs, which we see as an imperative in order to unleash their potential to reduce trial costs and accelerate the drug development process and the search for best treatments, so that the right treatments can be delivered as soon as possible to the right patients.

The Family Nurse Partnership to reduce maltreatment and improve child health and development in young children: the BB:2–6 routine data-linkage follow-up to earlier RCT

“…The reuse of trial data in tandem with use of routine service data is also consistent with policy imperatives for efficient study designs. 90,91 Although some costs involved in delivering this study were greater than anticipated for example, because of revisions in costing models used by NHS Digital, the total cost was substantially lower than would have been incurred if data were prospectively collected using maternal self-report.…”

Clinical research during the COVID-19 pandemic: The role of virtual visits and digital approaches

“…Although the pandemic has sped up the embrace of remote technologies for clinical research, their promise has been recognized for some time. Investigators have been exploring how digital technologies and advances could improve study feasibility and efficiency and lead to more representative study populations [1,2], as well as inform innovative study designs [3] and streamline clinical trial costs [3]. In the best of times, a number of barriers make it difficult for researchers to recruit participants who reflect the diversity of their communities.…”

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