Stakeholder views about the responsibilities of principal investigators in multicenter randomized controlled trials.

BACKGROUND/

aimsClinical trials are commonly believed to benefit from the involvement of an academic principal investigator who accepts responsibility for design, conduct, and reporting. Little evidence exists, however, about the importance that diverse stakeholders assign to the principal investigator's role in leadership of trials. Furthermore, few studies have examined whether and how beliefs about the role of the principal investigator might vary by funding source.

methodsWe conducted parallel Delphi panel surveys with seven stakeholder groups (principal investigators, patient advocates, journal editors, public funders, industry representatives, United States Food and Drug Administration officials, and clinical trial cooperative-group chairs) to assess the extent to which respondents believed leadership of a multicenter randomized controlled trial by an academic principal investigator to be important, considering publicly and industry-funded trials separately. We then surveyed an international sample of principal investigators (N = 92) who had recently published a multicenter randomized controlled trial in a high-impact general medical, oncology, cardiovascular, or psychiatry journal to assess their normative views on the importance of the academic principal investigator in leading both publicly and industry-funded trials.

resultsSeveral patterns emerged from the Delphi panel surveys. First, panelists viewed involvement of an identified academic principal investigator as most important at the design and planning and the interpretation and dissemination phases of a trial, as compared with the implementation and data collection phase. Second, panelists generally viewed involvement of an identified academic principal investigator as more important in publicly funded than in industry-funded trials. Finally, panelists representing industry stakeholders and United States Food and Drug Administration officials viewed involvement of an identified academic principal investigator as less important, especially for industry-funded trials, than did other groups. Respondents to the normative principal investigator survey generally endorsed the importance of academic principal investigators in leading multicenter randomized controlled trials, both overall (median rating 6 on the 0-6 point scale) and for trial-specific tasks. Both overall and with respect to specific tasks, however, respondents viewed an academic principal investigator's leadership as more important when considering publicly funded as compared with industry-funded trials.

conclusionAlthough members of most stakeholder groups participating in Delphi surveys view involvement of an academic principal investigator with overall responsibility for a multicenter randomized controlled trial as very important, there are notable differences depending on the respondent's perspective, the specific trial-related task, and the source of funding for the trial. In addition, principal investigators generally view an academic principal investigator as more important to the validity of a publicly funded multicenter randomized controlled trial than to the that of an industry-funded trial. These findings highlight the need to clarify the real-world practices of clinical trial leadership across diverse settings and to assess how those practices align with widely shared norms.