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B. Gitanjali, ICMJE statement on compulsory clinical trial registration: Should Indian journals follow suit? Indian Journal of Pharmacology, 37, 4 (2005). An editorial. (Thanks to D.K. Sahu.) Excerpt:
In May 2005, the International Council for Medical Journal Editors (ICMJE)...released a joint editorial statement on registration of clinical trials. ICMJE journals will consider manuscripts reporting clinical trials only if the trial was registered in a public registry before patient recruitment started....The ICMJE seeks to create an accessible and searchable public record of all clinical trials, containing all the relevant information clinicians need to make informed decisions regarding a particular treatment option, not just what "the researchers wanted to report and the editors chose to publish"....India is currently touted as a haven for clinical trials; it is projected that by 2010 clinical trials, to the tune of $250-300 million annually will be performed in India. In the absence of a national registry of clinical trials, Indian researchers and the public may not know what studies are being conducted on Indian soil, by whom and where. This results in duplication of work and wastage of resources. It exposes research participants to unnecessary risks. National funding agencies may sanction money for similar studies, unaware that such work is underway or has already been done, since adverse or negative results may not get published at all. Finally, it permits human research to be done without public scrutiny....In fact the ICMJE statement could be accepted not just by [Indian] editors but also as a prerequisite for funding by national agencies, award of degrees (if the trial formed part of a thesis) and even presentation at conferences. A public repository could be maintained of the kind being promoted in the US supported by all major funding bodies. All trials funded by national agencies should be registered here. Public funds are used for clinical trials on Indian systems of medicine and the public have a right to know about them. |
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