In September 2004, the International Committee of Medical Journal Editors (ICMJE) proposed a specific registration for clinical trials whose authors expect consideration for publication.1 Registration of clinical trials is an important issue. However, we felt uncomfortable with this proposal. Indeed, the ICMJE definition of clinical trial was quite ambiguous and ICMJE criteria excluded already mandatory registrations (i.e., European Medicines Agency).2 Now, registration of any clinical trial to be submitted for publication is mandatory, and the ICMJE states „each journal editor will decide on a case-by-case basis about reviewing unregistered trials.”3 This new rule for manuscript evaluation lacks transparency, transparency which was an end of this registration proposal. Last, no evaluation of this policy is planned.
The key to improving knowledge and the quality of trials is not to inflate regulations and guidelines, but rather to enforce already existing ones. For example, editors should endorse and implement the CONSORT (Consolidated Standards of Reporting Trials) statement, which gives recommendations for reporting randomized controlled trials. Only 22% of high-impact medical journals refer to CONSORT in their advice to authors, but many use ambiguous language regarding what is expected or fail to cite the up-to-date version.4 Please, no more clerical burden for the clinical investigator!
Footnotes
Competing interests: None declared.