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research letter

Indian Pediatr 2013;50: 339-340

Editorial Policies of MEDLINE Indexed Indian Journals on Clinical Trial Registration


Soumyadeep Bhaumik and Tamoghna Biswas

2, Amalangshu Sen Road, Kolkata 700 048, West Bengal, India.
Email: [email protected]



30 MEDLINE indexed Indian journals publishing clinical trials were identified and their editorial policies on trial registration were assessed. Trial registration number was required in 9 journals (30%).16 journals (53.33%) encouraged adherence to the CONSORT Statement, while 22 (73.33%) mentioned ICMJE Guidelines.

Key words: Clinical trials, Editorial policy, Registration.


ith a myriad of clinical trials being performed, there is a growing demand [1-3] for prospective registration of clinical trials to reduce selective reporting and publication bias, and enhance transparency, validity, availability and public accessibility of trial results. The International Committee of Medical Journal Editors (ICMJE) has made registration of trials a prerequisite for consideration of publication in its member journals [4]. The updated Consolidated Standards of Reporting Trials (CONSORT) Statement [5] includes ‘registration number and name of trial registry’ in its checklist for reporting of randomized controlled trials. Prospective trial registration has been made mandatory by the Drugs Controller General, India in the Clinical Trials Registry-India [6].

The National Library of Medicine (NLM) Catalog was searched on July 16, 2012 using the search string "India [country of publication] AND currently indexed." A list of 48 journals was retrieved and each journal was manually reviewed. Eight journals published by India-based publisher(s) but not having editorial office in India were excluded. Nine more journals were excluded because they primarily do not publish clinical trials. One journal had to be excluded as neither its website nor the print version could be located. Thirty journals were included in the final analysis. The ‘instructions for authors’ were downloaded from the website/online issues of the journals and were reviewed independently by each author. In case of disagreement, final decision was reached by consensus.

Nine journals (30%) required clinical trial registration number (CTRN) compulsorily for submission. This includes two journals, which did not mention explicitly about CTRN, but required authors to complete the CONSORT checklist. Journals which required compliance to CONSORT Statement but did not require submission of CONSORT checklist were considered not compulsorily requiring CTRN submission. One journal which mandatorily required registration of trials but did not ask for submission of CTRN was also marked in negation. One journal stated that registration is ‘desirable’ but did not specifically require submission of CTRN. 7 (23.3%) journals mentioned the name of at least one eligible clinical trial registry.

TABLE I	Association of Encouragement of CONSORT Adherence with CTRN Requirement

CTRN CTRN
required not required
CONSORT adherence mentioned 9 7
CONSORT adherence not mentioned 0 14
CONSORT: Consolidated standards of reporting trials;
CTRN; Clinical trial registration number.

16 (53.33%) journals (including two journals which required the submission of CONSORT checklist) encouraged authors to adhere to the CONSORT Statement. 7 (23.3%) journals encouraged adherence to the CONSORT statement but did not specifically require submission of CTRN or the CONSORT checklist. One journal which required compulsory trial registration did not mention CONSORT Statement. 22 (73.3%) journals mentioned ICMJE guidelines. Journals which encouraged CONSORT Statement adherence were more likely to require trial registration number for submission.

Out of the 11 signatories to the ‘Statement on publishing clinical trials in Indian biomedical journals’ [7], 9 journals were included in the present study (the other two were not currently indexed for MEDLINE). 4 journals (44.44%) required CTRN mandatorily for submission. One journal mentioned registration to be mandatory but did not mention about submission of CTRN. 6 journals (66.67%) encouraged adherence to the CONSORT Statement.

30% of the journals in our study mandatorily required CTRN. In a 2008 international survey [8], 37% of journals mentioned about clinical trial registration while 26.7% required registration as a prerequisite for submission. 53.3% of journals in the present study mentioned about the CONSORT statement compared to 38% in the 2008 study [8].

The present study is limited by the fact that it includes only Indian journals which are currently indexed for MEDLINE. The present study highlights that a majority of the journals are yet to adapt their editorial policies with regard to the issue of clinical trial registration.

Contributors: Authors contributed equally to the work.

Funding: None: Competing interests: SB has previously held a paid medical subeditor position a medical journal. Currently, SB is the resident editor of a journal published by Indian Medical Association, and also serves in the editorial board of another non-Indian medical journal. TB has no financial conflicts of interest but he has served in editorial board of a student medical journal, and has been a reviewer for multiple medical journals. He has no association with any of the journals included in this study.

References

1. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986;4:1529-41.

2. Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, et al. Clinical trial registration— looking back and moving ahead. N Engl J Med. 2007;356:2734-6.

3. Surgery Journal Editors Group. Consensus statement on mandatory registration of clinical trials. J Pediatr Surg. 2007;42:601-2.

4. Obligation to Register Clinical Trials. International Committee of Medical Journal Editors Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Publishing and Editorial Issues Related to Publication in Biomedical Journals. Available from: URL: http://www.icmje.org/publishing_10register.html. Accessed July 11, 2012.

5. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med. 2010;152.

6. About CTRI. Clinical Trials Registry-India. Available from: URL: http://ctri.nic.in/Clinicaltrials/cont1.php. Accessed July 11, 2012.

7. Satyanarayana K, Sharma A, Parikh P, Vijayan VK, Sahu DK, Nayak BK, et al. Statement on publishing clinical trials in Indian biomedical journals. Indian J Ophthalmol. 2008;56:177-8.

8. Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal ‘Instructions to Authors’. Trials. 2008;18;9:20.

 

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