How do researchers decide early clinical trials?

by

Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials.

In our recent article published in Medicine, Health Care and Philosophy, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch- concentrating on evidentiary factors used to justify launch of clinical development and to evaluate risk and benefit for subjects. We conclude that existing policies grants very wide moral and scientific discretion to research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and find that decision-making surrounding trial launch is not simply- or even primarily- centered on proof of principle or concerns about subject welfare. It involves a constellation of commercial, regulatory, and professional considerations. Investigators are adept at establishing and maintaining their authority over decisions surrounding trial launch, and they emphasize that preclinical research is an important resource in legitimizing trial launch and enrolling other actors. However, nothing in this last point suggests that preclinical studies are mere rhetorical devices. If preclinical research is a key resource in enrolling other actors, it is surely because it contains content that resolve certain uncertainties.

We close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research. We suggest that by investigating how various stakeholders describe, reason about, approach and resolve questions about ethics and study validity guidance can be established on a design and review principles for trial launch. Such an approach can pay dividends by improving human protections, reducing attrition in drug development, and reducing costly uncertainties encountered in deciding launch of clinical development.

BibTeX

@Manual{stream2016-970,
    title = {How do researchers decide early clinical trials?},
    journal = {STREAM research},
    author = {Hannah Grankvist},
    address = {Montreal, Canada},
    date = 2016,
    month = mar,
    day = 7,
    url = {http://www.translationalethics.com/2016/03/07/how-do-researchers-decide-early-clinical-trials/}
}

MLA

Hannah Grankvist. "How do researchers decide early clinical trials?" Web blog post. STREAM research. 07 Mar 2016. Web. 17 Oct 2019. <http://www.translationalethics.com/2016/03/07/how-do-researchers-decide-early-clinical-trials/>

APA

Hannah Grankvist. (2016, Mar 07). How do researchers decide early clinical trials? [Web log post]. Retrieved from http://www.translationalethics.com/2016/03/07/how-do-researchers-decide-early-clinical-trials/


Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Search STREAM

Old blog posts


All content © STREAM research

admin@translationalethics.com
Twitter: @stream_research
3647 rue Peel
Montreal QC H3A 1X1