Agreements on publication rights: an investigation of protocols and publications of randomized clinical trials

Oral
2015 Vienna
Kasenda B1, Amstutz A2, Von Elm E3, You J4, Blümle A5, Tomonaga Y6, Saccilotto R2, Bengough T7, Meerpohl J5, Stegert M2, Olu K2, Tikkinen K4, Neumann I4, Carrasco-Labra A4, Faulhaber M4, Mulla S4, Mertz D4, Akl E4, Bassler D8, Busse J4, Ferreira-González I9, Lamontagne F10, Nordmann A2, Gloy V2, Raatz H2, Moja L11, Ebrahim S4, Schandelmaier S2, Sun X12, Vandvik P13, Johnston B4, Walter M14, Burnand B3, Schwenkglenks M6, Kasenda L2, Bucher H2, Guyatt G4, Briel M2
1Royal Marsden Hospital, United Kingdom
2Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland
3Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland
4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
5German Cochrane Centre, Medical Center – University of Freiburg, Freiburg, Germany
6Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich, Zurich, Switzerland
7Austrian Federal Institute for Health Care, Department of Health and Society, Vienna, Austria
8Department of Neonatology, University Hospital Zurich, Zurich, Switzerland
9Epidemiology Unit, Department of Cardiology, Vall d'Hebron Hospital and CIBER de Epidemiología y Salud Publica (CIBERESP), Barcelona, Spain
10Centre de Recherche Clinique Étienne-Le Bel and Department of Medicine, Université de Sherbrooke, Sherbrooke, Canada
11CS Orthopedic Institute Galeazzi, Milano, Italy
12Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
13Department of Medicine, Innlandet Hospital Trust-Division Gjøvik, Oppland, Norway
14Institute of Nuclear Medicine, University Hospital Bern, Bern, Switzerland

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.