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Year : 2011  |  Volume : 57  |  Issue : 1  |  Page : 82-83

Reporting of the methodological quality and ethical aspects in clinical trials published in Indian journals: A survey

Department of Pharmacology, Govt. Medical College, Surat, India

Date of Web Publication31-Jan-2011

Correspondence Address:
Department of Pharmacology, Govt. Medical College, Surat
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0022-3859.74300

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How to cite this article:
Jaykaran, Kantharia N D, Yadav P, Deoghare S. Reporting of the methodological quality and ethical aspects in clinical trials published in Indian journals: A survey. J Postgrad Med 2011;57:82-3

How to cite this URL:
Jaykaran, Kantharia N D, Yadav P, Deoghare S. Reporting of the methodological quality and ethical aspects in clinical trials published in Indian journals: A survey. J Postgrad Med [serial online] 2011 [cited 2023 May 28];57:82-3. Available from:


Methodological and ethical aspects are important components of reporting of clinical trials. These aspects should be adequately reported so that readers can make an accurate assessment of the clinical research reported in the publication. [1] As it is observed that methodological and ethical aspects are not adequately reported in published clinical trials, [2] we decided to survey the clinical trials published in four Indian journals [viz. Journal of Postgraduate Medicine (JPGM), Indian Pediatrics (IP), Indian Journal of Dermatology, Venerology and Leprology (IJDVL) and Indian Journal of Pharmacology (IJP)] for the reporting of ethical aspects and methodological quality. Every author surveyed all the clinical trials published in these journals in 2007-2008 on the basis of a checklist [Table 1]. We specifically focused reporting of ethical approval and written informed consent from participants, consent from parents in pediatric population and assent of pediatric patients of age more than 7 years. Checklist for methodological aspects was prepared on the basis of CONSORT statement. "Instruction to authors" sections of all these four journals have guidelines regarding ethical aspect and use CONSORT checklist for reporting of clinical trials. [3]
Table 1: Methodological quality of clinical trials published in Indian journals

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Of the 30 trials (6 from JPGM, 12 from IP, 8 from IJVDL and 4 from IJP), 2 were single-blinded and 4 were open label trials. Twenty-seven (90%) trials reported permission of the ethics committee. Three trials, which did not report regarding ethical approval, were published in IJDVL. Written informed consent from participants was reported in 29 trials (96.6%). We noted that pediatric population was enrolled in 13 trials. In these trials, consent from parents was reported in 11 (84.6%) publications. A total of 9 clinical trials out of 13 pediatric trials enrolled patients having age more than 7 years. We observed that assent from the participants were reported in all nine clinical trials.

We observed that planned study population, inclusion and exclusion criteria, planned intervention and timing of intervention were reported in all the trials. In 19 (63.3%) trials, there was no division between primary and secondary end points [Table 1]. Selection of primary end point prevents the inflation of type I error because of the multiple end points. Minimum difference of outcome was mentioned in about half of the trials [Table 1]. This is useful in the calculation of the sample size. In all the trials where minimum difference of outcome was mentioned, sample size was calculated. Rational and method of statistics was reported in most of the trials. Other results are summarized in [Table 1].

Similar findings were observed in other studies which were based on clinical trials published in western journals. [2],[4] We believe there is a definitive improvement in reporting of ethical aspect as compared to previous studies in Indian setting. [5] We believe that editors should generate more awareness regarding the methodological quality of research. It is observed that use of CONSORT checklist is associated with the improvement in reporting of methodological quality of clinical trials. [6] So, editors should encourage the use of CONSORT checklist. Postgraduate students and faculties should be trained in research methodology and biostatistics so that they can not only critically evaluate what is published but also write an effective manuscript of there research. Every journal should have a statistician and every article should also be appraised for the accuracy of statistical reporting. To decrease the chance of type 1 errors, some statistical methods like Bonferroni correction, composite end point methods, etc., should be used. [7]

 :: References Top

1.Altman DG. Better reporting of randomised controlled trials: The CONSORT statement. BMJ 1996;313:570-1.  Back to cited text no. 1
2.Ruiz-Canela M, de Irala-Estevez J, Martνnez-Gonzαlez MA, Gσmez-Gracia E, Fernαndez-Crehuet J. Methodological quality and reporting of ethical requirements in clinical trials. J Med Ethics 2001;27:172-6.  Back to cited text no. 2
3.Moher D, Schulz KF, Altman DG. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001;134:657-62.   Back to cited text no. 3
4.Greenfield ML, Rosenberg AL, O'Reilly M, Shanks AM, Sliwinski MJ, Nauss MD. The quality of randomized controlled trials in major anesthesiology journals. Anesth Analg 2005;100:1759-64.  Back to cited text no. 4
5.Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci 2008;62:134-40.   Back to cited text no. 5
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6.Moher D, Jones A, Lepage L; CONSORT Group (Consolitdated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: A comparative before-and-after evaluation. JAMA 2001;285:1992-5.  Back to cited text no. 6
7.Ton J, Aeilko H. Clinical trials are often false positive: A review of simple methods to control this problem. Curr Clin Pharmacol 2006;1:1-4.  Back to cited text no. 7


  [Table 1]

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