Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency

TY - JOUR

T1 - Disclosure of investigators' recruitment performance in multicenter clinical trials

T2 - a further step for research transparency

AU - Dal-Re, Rafael

AU - Moher, David

AU - Gluud, Christian

AU - Treweek, Shaun

AU - Demotes-Mainard, Jacques

AU - Carne, Xavier

PY - 2011/12

Y1 - 2011/12

N2 - * Many clinical trials are terminated before reaching the sample size needed to test the trials' hypotheses owing to poor recruitment. * Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public. * Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available. * We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided. * This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks. * Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.

AB - * Many clinical trials are terminated before reaching the sample size needed to test the trials' hypotheses owing to poor recruitment. * Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public. * Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available. * We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided. * This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks. * Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.

U2 - 10.1371/journal.pmed.1001149

DO - 10.1371/journal.pmed.1001149

M3 - Article

C2 - 22215987

SN - 1549-1277

VL - 8

SP - -

JO - PLoS Medicine

JF - PLoS Medicine

IS - 12

M1 - e1001149

ER -