Tag Archives: clinical trials

Indian journals fair poorly with respect to clinical trial registration details for publication.

CaptureProspective registration of clinical trials has been made mandatory by various government regulations. The ICMJE guidelines require a clinical trial to be registered as a prerequisite for publication while the revised CONSORT Statement requires the authors to submit the trial registration number and name of registry while reporting of clinical trials.

A short study of ‘instructions for authors’ of MEDLINE indexed Indian medical and dental journals publishing clinical trials to assess their editorial policies on trial registration was done by Dr. Soumyadeep B and his colleague .

They identified 30 journals from the National Library of Medicine Catalog meeting our study criteria. From the websites of these journals, they accessed the ‘instructions for authors’ and extracted information on requirement of trial registration number during submission of clinical trials, mention about any eligible trial registry, endorsement of CONSORT Statement in reporting of trials and mention about the ICMJE Guidelines.
Results :Trial registration number was required in only 30 % journals (9/30, 30%). Only 16 journals (16/30, 53.33%) encouraged adherence to the CONSORT Statement in reporting of trials, while 22 journals (22/30, 73.33%) mentioned about ICMJE Guidelines in their instructions.

The study shows an urgent need of uniform endorsement of international standards in registration and reporting of clinical trials by the journals and identifies a major issue in the medical publishing arena in India. Read the full study titled ” Editorial Policies of MEDLINE Indexed Indian Journals on Clinical Trial Registration  ” published in the esteemed medical journal Indian Pediatrics here. (OPEN ACCESS)

Clinical Trial Data and the “Do no harm” principle

In an era of evidence based medicine clinical trials hold the key to validate or negate a medical intervention, whatsoever is its nature. However, clinical trials have been under increased scrutiny in the recent past due to concerns over violations of ethical concerns and research related injury. Thus it has become imperative on the part of those at the helm of affairs of clinical trials (drug makers as well as non-governmental organisations and governments which funds such studies) to make available the full and complete information of clinical trial available in public domain.

Making clinical trial data available right from the initial phase’s right till its end in the public domain not only enhances the transparency and validity of the trial it is also beneficial to those running the trial itself. It helps to improve the quality of clinical trials by making it possible to identify potential problems as well as allow health care practitioners to identify researchers related to their field.

Read Dr. Soumyadeep B’s response to the BMJ Open Data Campaign at the British Medical Journal (Open Access)