Normative arguments and new solutions for the unbiased registration and publication of clinical trials.
OBJECTIVE
To present a structured account of ethical problems and possible solutions related to selective publication and incomplete trial registration.


METHODS
The presentation of ethical problems and possible solutions is structured using the tools of conceptual normative analysis.


RESULTS
Selective publication runs contrary to (1) principles of ethical research, such as social value and respect for participants, (2) sound medical decision making and clinical guideline development, (3) appropriate patient information, (4) public trust in clinical research, and (5) just allocation of public resources for clinical research. Reasons against the obligation of complete registration and publication of trials can be divided into (1) protection of private data and (2) commercial interests. Empirical findings indicate that selective publication and incomplete trial registration (1) are frequent, (2) extensively distort patient-relevant outcomes, and (3) affect a large number of patients.


CONCLUSIONS
Empirical data and normative arguments outweigh their counterarguments and present a clear case in favor of an even more restrictive obligation to register trials. Institutional review boards and better-educated stakeholders might play a crucial role in facilitating unbiased registration and publication of clinical research. For evaluation purposes, the field needs better standards for study protocols.
CELLS-Centre for Ethics and Law in the Life Science, Institute for History, Ethics and Philosophy of Medicine, Hannover Medical School, Carl-Neuberg Straße Street 1, Hannover, Germany. strech.daniel@mh-hannover.de
Daniel
D
Strech
D002986:Clinical Trials as Topic / Q000592:standards*; D036262:Empirical Research; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D017594:Publication Bias; D011643:Publishing / Q000941:ethics* / Q000592:standards; D012042:Registries / Q000592:standards*