Is this clinical trial fully registered?
http://www.100md.com
《加拿大医疗协会学报》
Alain Braillon and Gérard Dubois ask some important questions.
The ICMJE definition of a clinical trial could not take into account the (multiple) definitions of clinical trials used by various registries. We were interested in capturing clinical trials that were likely to contain information relevant to clinical practice. The problem of definition is most acute for very early clinical trials, often referred to as Phase 2 trials, whose purpose can be to determine recruitment strategies, compliance, frequencies of primary outcomes and the like. These trials are not intended to provide meaningful outcomes that can be used to guide clinical or preventive practice. Although other national registries, such as the European Medicines Agency, may require these types of trials to be registered, the ICMJE does not. Obviously, the ICMJE is supportive of more inclusive registries.
Case-by-case consideration was added for several reasons, but chief among them was the vagueness of the definition of an eligible Phase 2 trial. We recognized that some Phase 2 trials, designed to help plan Phase 3 trials (and thus not in need of registration according to the ICMJE definition) might yield unanticipated information and results that had clinical applicability, such as an unexpected efficacious result or serious adverse events. Also, there was bound to be some failure to register, possibly among trialists from small centres or parts of the world that are not aware of the deadlines. We are reasonable bunch, and we are trying to be transparent.
We welcome efforts to evaluate the policy and expect that journalogists and others will be looking for results and tracking progress. We very much encourage groups such as yours to undertake this type of study.
Lastly, I agree that editors should do better at encouraging authors of accepted papers to use the CONSORT guidelines.
Footnotes
Competing interests: I am a coauthor of the ICMJE statement on clinical trials registration and editor of a journal that supports efforts to publicly register clinical trials.(John Hoey)
The ICMJE definition of a clinical trial could not take into account the (multiple) definitions of clinical trials used by various registries. We were interested in capturing clinical trials that were likely to contain information relevant to clinical practice. The problem of definition is most acute for very early clinical trials, often referred to as Phase 2 trials, whose purpose can be to determine recruitment strategies, compliance, frequencies of primary outcomes and the like. These trials are not intended to provide meaningful outcomes that can be used to guide clinical or preventive practice. Although other national registries, such as the European Medicines Agency, may require these types of trials to be registered, the ICMJE does not. Obviously, the ICMJE is supportive of more inclusive registries.
Case-by-case consideration was added for several reasons, but chief among them was the vagueness of the definition of an eligible Phase 2 trial. We recognized that some Phase 2 trials, designed to help plan Phase 3 trials (and thus not in need of registration according to the ICMJE definition) might yield unanticipated information and results that had clinical applicability, such as an unexpected efficacious result or serious adverse events. Also, there was bound to be some failure to register, possibly among trialists from small centres or parts of the world that are not aware of the deadlines. We are reasonable bunch, and we are trying to be transparent.
We welcome efforts to evaluate the policy and expect that journalogists and others will be looking for results and tracking progress. We very much encourage groups such as yours to undertake this type of study.
Lastly, I agree that editors should do better at encouraging authors of accepted papers to use the CONSORT guidelines.
Footnotes
Competing interests: I am a coauthor of the ICMJE statement on clinical trials registration and editor of a journal that supports efforts to publicly register clinical trials.(John Hoey)