Barriers and Facilitating Factors for Conducting Systematic Evidence Assessments in Academic Clinical Trials

Abstract

IMPORTANCE A systematic assessment of existing research should justify the conduct and inform the design of new clinical research but is often lacking. There is little research on the barriers to and factors facilitating systematic evidence assessments. OBJECTIVE To examine the practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials. DESIGN, SETTING, AND PARTICIPANTS In this qualitative study, individual semistructured qualitative interviews were conducted between February and August 2020 with 48 Swiss stakeholder groups (27 primary investigators, 9 funders and sponsors, 6 clinical trial support organizations, and 6 ethics committee members) and between January and March 2021 with 9international funders of clinical trials from North America and Europe with a reputation for requiring systematic evidence synthesis in applications for academic clinical trials. MAIN OUTCOMES AND MEASURESThe main outcomes were practices and attitudes of Swiss stakeholders and international funders regarding conducting systematic evidence assessments in academic clinical trials. Interviews were analyzed using conventional content analysis. RESULTSOf the 57 participants, 40 (70.2%) were male. Participants universally acknowledged that a comprehensive understanding of the previous evidence is important but reported wide variation regarding how this should be achieved. Participants reported that the conduct of formal systematic reviews was currently not expected before most clinical trials, but most international funders reported expecting a systematic search for the existing evidence. Whereas time and resources were reported by all participants as barriers to conducting systematic reviews, the Swiss research ecosystem was reported not to be as supportive of a systematic approach compared with international settings. CONCLUSIONS AND RELEVANCEIn this qualitative study, Swiss stakeholders and international funders generally agreed that new clinical trials should be justified by a systematic evidence assessment but that barriers on individual, organizational, and political levels kept them from implementing it. More explicit requirements from funders appear to be needed to clarify the required level of comprehensiveness in summarizing existing evidence for different types of clinical trials.

Methods proposed for monitoring the implementation of evidence-based research: a cross-sectional study

“…Some of the challenges mentioned by the experts are associated with barriers and facilitators for EBR. In 2021, McLennan et al published a study of practices and attitudes of Swiss stakeholders and international funders about conducting systematic evidence assessments to inform academic clinical trials [21]. Their qualitative study included 48 participants from various stakeholder groups, including primary investigators, funders and sponsors, clinical trial support organizations, and ethics committee members.…”

Rapid reviews methods series: assessing the appropriateness of conducting a rapid review

“…Justify or inform new primary research: RRs can justify or inform the design of new primary studies in situations with limited resources 42…”

Implementing Incentives and Rewards to Improve the Research Ecosystem

“…There are many examples of waste throughout the entire research process, from the questions being asked all the way through to the completeness and transparency of how the completed research is communicated and disseminated. The article by McLennan et al provides more evidence concerning the continued propagation of waste in clinical research. In my interpretation of the results, clinical trialists (largely from Switzerland) and funders (global) are vague as to the merits and implementation of systematic reviews when proposing new clinical trials.…”

“…Would the involvement of patients in this project have provided a more forceful message about the importance of systematic reviews as a sound and necessary perquisite for the conduct of clinical trials? Currently, clinical trialists do not share the data from their clinical trials and also worry about other researchers publishing before them.…”

“…The qualitative analyses also indicate that clinical trialists may not have the requisite knowledge or experience to conduct systematic reviews as part of trial preparations. This may be a jurisdictional issue because many interviewees were from Switzerland.…”