Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility

Jecker, Nancy S.; Wightman, Aaron; Rosenberg, Abby R.; Diekema, Douglas S.

doi:10.1080/15265161.2018.1444817

Cited by 9 publications

(3 citation statements)

References 20 publications

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“…Ideally, coordination and prioritization of trials would occur upstream (e.g. among manufacturers 16 and funders) and at a higher level than the individual institution (i.e. regionally, nationally, or internationally).…”

Section: Introductionmentioning

confidence: 99%

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

Meyer

Gelinas²,

Bierer

et al. 2021

Clinical Trials

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Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g. nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.

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Section: Introductionmentioning

confidence: 99%

An ethics framework for consolidating and prioritizing COVID-19 clinical trials

Meyer

Gelinas²,

Bierer

et al. 2021

Clinical Trials

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show abstract

“…Others have previously considered the implications of using the traditional frameworks (egalitarian, utilitarian, prioritarian) as a basis for allocation in a research rather than clinical setting (Frye 2018;Jecker et al 2018). However, this effort focused on the allocation of a scarce intervention in a clinical setting, rather than the additional complications of scarce funding and participants, as is the case in current COVID-19 research.…”

Section: Future Allocationmentioning

confidence: 99%

Resource Allocation in COVID-19 Research: Which Trials? Which Patients?

Wieten

Burgart

Cho

2020

The American Journal of Bioethics

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“…Consider, for instance, the framework’s equal opportunity criterion, which attempts to provide the “minimal amount of production capacity necessary” for each trial by specifying “the number of participants and amount of product required to produce scientifically meaningful results in a reasonable timeframe ” (emphasis added). (Jecker et al 2018) Manufacturers would allocate production capacity on the basis of a power calculation for each trial – for example, finding the number of participants needed for a study to have a two-sided significance level of 5% and a statistical power of at least 80%. Note that power calculations incorporate one’s risk tolerance, assumptions, and estimates.…”

mentioning

confidence: 99%