Article type
Year
Abstract
Background: About 25% of randomized clinical trials (RCTs) are prematurely discontinued; mainly due to slow recruitment of participants. Up to 60% of discontinued RCTs remain unpublished. The Swiss National Science Foundation (SNSF), the main public funding body for research in Switzerland, promotes academic excellence, and evaluates study proposals critically. It remains unclear, whether RCTs selected competitively for funding by the SNSF have a lower risk of discontinuation or non-publication.
Objectives: To assess and compare completion and publication status of SNSF-supported RCTs with non-SNSF supported Swiss RCTs from a similar time period.
Methods: We systematically identified SNSF-supported RCTs in health care up to May 2015 and extracted in duplicate trial characteristics from corresponding proposals. For each RCT, we searched for corresponding publications and conducted a survey of principal investigators for information about discontinuation and publication of RCTs. We used multivariable logistic regression and data from previous empirical work to compare risks for discontinuation of SNSF-supported RCTs to Swiss investigator-initiated RCTs not supported by the SNSF and industry-sponsored RCTs.
Results: Out of 101 RCTs that were supported by the SNSF between 1986 and 2015, 61 RCTs were completed as planned, 34 were prematurely discontinued (all due to slow recruitment), and the completion status remained unclear for six RCTs. Fifty-three RCTs were published in peer-reviewed journal articles. Ninety-five principal investigators responded to our survey. SNSF-funded RCTs were equally likely to be discontinued as non-SNF RCTs (adjusted odds ratio (OR) 1.62, 95% confidence interval (CI) 0.82 to 3.21) and more likely to be discontinued compared to industry-sponsored RCTS (adjusted OR 6.45, 95% CI 2.94 to 14.40), both due to slow recruitment.
Conclusions: One-third of RCTs funded by the SNSF were prematurely discontinued and more than 40% remain unpublished. Approval and support from the SNSF does not seem to lower the risk for discontinuation or non-publication of RCTs in Switzerland.
Objectives: To assess and compare completion and publication status of SNSF-supported RCTs with non-SNSF supported Swiss RCTs from a similar time period.
Methods: We systematically identified SNSF-supported RCTs in health care up to May 2015 and extracted in duplicate trial characteristics from corresponding proposals. For each RCT, we searched for corresponding publications and conducted a survey of principal investigators for information about discontinuation and publication of RCTs. We used multivariable logistic regression and data from previous empirical work to compare risks for discontinuation of SNSF-supported RCTs to Swiss investigator-initiated RCTs not supported by the SNSF and industry-sponsored RCTs.
Results: Out of 101 RCTs that were supported by the SNSF between 1986 and 2015, 61 RCTs were completed as planned, 34 were prematurely discontinued (all due to slow recruitment), and the completion status remained unclear for six RCTs. Fifty-three RCTs were published in peer-reviewed journal articles. Ninety-five principal investigators responded to our survey. SNSF-funded RCTs were equally likely to be discontinued as non-SNF RCTs (adjusted odds ratio (OR) 1.62, 95% confidence interval (CI) 0.82 to 3.21) and more likely to be discontinued compared to industry-sponsored RCTS (adjusted OR 6.45, 95% CI 2.94 to 14.40), both due to slow recruitment.
Conclusions: One-third of RCTs funded by the SNSF were prematurely discontinued and more than 40% remain unpublished. Approval and support from the SNSF does not seem to lower the risk for discontinuation or non-publication of RCTs in Switzerland.