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Volume 26 |
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Published by : PROFESSIONAL MEDICAL PUBLICATIONS |
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Volume 26 |
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Number 1 |
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Reporting statistics in clinical trials published
in Indian journals: A surveyJay Karan1, ND Kantharia2, Preeti Yadav3, Pankaj Bhardwaj4
ABSTRACT
objective: Clinical trials are having very important place in the hierarchy of evidence based medicine. It has been observed that current methods of use and reporting of statistics of clinical trials are responsible for errors in the interpretation of results.We decided to evaluate clinical trials published during 2007 and 2008 in four Indian journals to analyses statistical issues which may affect the interpretation of results.
Methodology: We analyzed all the clinical trials (46) published in Indian Pediatrics, Indian Journal of Pharmacology, Journal of Postgraduate Medicine and Indian Journal of Dermatology, Vanereology and Leprology in 2007-2008.
Results: Median number of end points reported in clinical trials as well as median number of end points which were used for testing of significance was four. Twenty one (45%) of trials reported repeated measurement. Eighteen (39%) trials had three or more than three treatment groups. median number of test of significance was 15. post hoc subgroup analysis was done in 19% (9) of trials. P value was the sole criteria for interpretation of results in most of the trials; confidence interval was calculated in 11 (23%) trials. Baseline comparison between the study groups was done in 41 (89%) trials. In all cases comparison was done by statistical tests. Exact sample size was calculated in 18 (39%) trials.
Conclusion: There are great chances of committing error during the interpretation of results of these trials because of multiple treatment groups, repeated measurements of endpoints, multiple tests of significance, over reliability on P value and less use of confidence interval. Statistical methods available to reduce chances of errors should be used and result should be interpreted accordingly.
KEY WORDS:
Clinical trials, Statistics, Type-1 error.Pak J Med Sci January - March 2010 Vol. 26 No. 1 212-216
How to cite this article:
Karan J, Kantharia ND, Yadav P, Bhardwaj P. Reporting statistics in clinical trials published in Indian journals: A survey. Pak J Med Sci 2010;26(1):212-216
1. Dr. Jay Karan,
MD (Pharmacology),
PG Diploma in Research Methodology,
Assistant Professor
2. Dr. N. D. Kantharia
Professor and Head
3. Dr. Preeti Yadav,
MD (Pharmacology),
Associate Professor
4. Dr. Pankaj Bhardwaj,
MD (Community Medicine),
Assistant Professor,
Dept. of Community Medicine,
Era’s Lucknow Medical College,
Lucknow - India.
1-3. Dept of Pharmacology,
Govt. Medical College,
New Civil Hospital,
Surat India- 395001.
Correspondence:
Dr. Jay Karan,
MD (Pharmacology), PG Diploma in Research Methodology
Assistant Professor,
Department of Pharmacology,
Govt. Medical College,
New Civil Hospital
Surat - India 395001.
E-mail: drjaykaran@yahoo.co.in
pali6gadh@yahoo.com
* Received for Publication: October 8, 2009
* Revision Received: November 18, 2009
* Revision Accepted: November 21st 2009
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