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because they primarily do not publish clinical trials.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.