Article type
Year
Abstract
Background: For-profit companies conducting randomized clinical trials (RCTs) often make contracts with academic investigators. Little is known about the content of publication agreements documented in RCT protocols, and the accuracy of corresponding statements in published RCTs.
Objectives: To investigate:
1. existence and type of publication agreements in RCT protocols;
2. the completeness and accuracy of the corresponding reporting in subsequent publications.
Methods: We identified a retrospective cohort of RCTs based on archived protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. Last follow-up of RCTs was 27 April 2013. Only RCTs with industry involvement were eligible. Outcomes: Documentation of publication agreements in RCT protocols and their concordance with reported statements in journal publications.
Results: Six-hundred and forty-seven RCT protocols were eligible (Figure 1), of these, 456 (70.5%) mentioned an agreement regarding publication of results. Of these, 156 (34.2%) documented an industry-sponsor’s right to disapprove proposed manuscripts; 237 (52.0%) an industry-sponsor’s right to review any manuscript before publication; and 39 (8.6%) of agreements had no constraints regarding publication. The remaining protocols referred to separate agreements that were not accessible to us. We identified 388 publications corresponding to the 647 protocols (60%); in 290 (74.7%) authors did not report any agreement regarding publication although 197 of the corresponding 290 protocols (67.9%) explicitly mentioned such agreements. Only 30 (30.6%) out of 98 (25.3%) publications reporting on agreements about publication were concordant with statements in the corresponding protocols (Table 1).
Conclusions: Agreements on publication rights between industry sponsors and academic investigators are common in RCT protocols. In a third, the industry sponsors retain the right to disapprove manuscripts for publication. Journal articles seldom report on publication agreements and, if they do, statements are often discrepant with the trial protocol.
Objectives: To investigate:
1. existence and type of publication agreements in RCT protocols;
2. the completeness and accuracy of the corresponding reporting in subsequent publications.
Methods: We identified a retrospective cohort of RCTs based on archived protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. Last follow-up of RCTs was 27 April 2013. Only RCTs with industry involvement were eligible. Outcomes: Documentation of publication agreements in RCT protocols and their concordance with reported statements in journal publications.
Results: Six-hundred and forty-seven RCT protocols were eligible (Figure 1), of these, 456 (70.5%) mentioned an agreement regarding publication of results. Of these, 156 (34.2%) documented an industry-sponsor’s right to disapprove proposed manuscripts; 237 (52.0%) an industry-sponsor’s right to review any manuscript before publication; and 39 (8.6%) of agreements had no constraints regarding publication. The remaining protocols referred to separate agreements that were not accessible to us. We identified 388 publications corresponding to the 647 protocols (60%); in 290 (74.7%) authors did not report any agreement regarding publication although 197 of the corresponding 290 protocols (67.9%) explicitly mentioned such agreements. Only 30 (30.6%) out of 98 (25.3%) publications reporting on agreements about publication were concordant with statements in the corresponding protocols (Table 1).
Conclusions: Agreements on publication rights between industry sponsors and academic investigators are common in RCT protocols. In a third, the industry sponsors retain the right to disapprove manuscripts for publication. Journal articles seldom report on publication agreements and, if they do, statements are often discrepant with the trial protocol.