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How do researchers decide early clinical trials?
Hannah Grankvist1, Jonathan Kimmelman2
1Department of Thematic Studies - Technology and Social Change, Linköping University, 581 83, Linköping, Sweden. hannah.grankvist@liu.se.
Medicine, Health Care, and Philosophy
|February 3, 2016
Summary
Launching early phase clinical trials involves significant risks for human subjects. Current policies offer limited guidance, leaving critical decisions to research teams and sponsors, necessitating further research into their decision-making processes.
Area of Science:
- Clinical research ethics
- Drug development
- Regulatory science
Background:
- Launching early phase clinical trials represents a major commitment and exposes participants to novel interventions.
- Existing frameworks provide insufficient guidance for the scientific and ethical evaluation of these trials.
Purpose of the Study:
- To review existing policies and consensus statements regarding the launch of early phase clinical trials.
- To understand how research teams and sponsors make decisions in this context.
- To propose a research agenda for studying decision-making in early phase research.
Main Methods:
- Review of policies and consensus statements on human protections, drug regulation, and research design.
- Analysis of current understanding of decision-making processes by research teams.
- Identification of gaps in knowledge regarding investigator, sponsor, and reviewer discretion.
Main Results:
- Decision-making for early phase trial launches is predominantly at the discretion of research teams and sponsors.
- There is a lack of comprehensive guidance for evaluating the scientific and ethical aspects of these trials.
- Limited understanding exists regarding the specific factors influencing these decisions.
Conclusions:
- Current policies inadequately support decision-making for early phase clinical trial launches.
- Further research is needed to characterize and potentially standardize the decision-making approaches used by investigators, sponsors, and reviewers.
- Establishing clearer guidelines could enhance the scientific rigor and ethical oversight of early phase research.
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