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Year : 2016  |  Volume : 2  |  Issue : 1  |  Page : 57-58

Formulation of a Comprehensive Protocol in Clinical Trials

Department of Community Medicine, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, Tamil Nadu, India

Date of Web Publication25-Jan-2016

Correspondence Address:
Saurabh R Shrivastava
Department of Community Medicine, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, Tamil Nadu
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2394-7438.174837

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How to cite this article:
Shrivastava SR, Shrivastava PS, Ramasamy J. Formulation of a Comprehensive Protocol in Clinical Trials. MAMC J Med Sci 2016;2:57-8

How to cite this URL:
Shrivastava SR, Shrivastava PS, Ramasamy J. Formulation of a Comprehensive Protocol in Clinical Trials. MAMC J Med Sci [serial online] 2016 [cited 2021 Sep 16];2:57-8. Available from: https://www.mamcjms.in/text.asp?2016/2/1/57/174837


Globally, a rapid upsurge in the incidence of clinical trials has been observed in heterogeneous settings in order to upgrade the quality of healthcare standards of the general population.[1] However, it is very much essential to first justify the necessity of a clinical trial before conducting the same.[1],[2] In fact, factors such as the extent of the problem, availability of facts suggestive of the existence of multiple gaps in the present knowledge, expected merits associated with the results of the trial, and ethical appropriateness, together provide justification for the conduct of the trial.[1],[2]

Most of the concerns associated with the clinical trials, especially the safety of the participants can be sorted out through the formulation of a comprehensive protocol.[3] Over the years, multiple reports of unethical or nonscientific clinical trials have been observed in India, which raised grave objections about the overall reliability and validity of the trial results.[4],[5] Furthermore, it has been even acknowledged that a transparent, detailed, and clearly written protocol can even aid in the periodic assessment of the trial.[2],[3]

In general, protocol for a clinical trial refers to a document which not only explains the existing knowledge and need of the trial, but also even provides a detailed information about the proposed hypothesis, predefined aims and objective(s), adopted methodology, and organization of the trial.[2] The designed objectives should be clear and feasible and should not be modified after starting the trial.[6],[7] It is very much essential to mention the precise duration, inclusion and exclusion criteria, and the sample size of the study, which should be obtained using a scientific approach with all possible justifications.[2],[3] In addition, the protocol should contain a section to reveal its compliance with good clinical practice and ethical considerations (such as informed consent, and patient information sheet), based on the nature of the trial.[1],[8]

As in other research proposals, methodology section is considered the key element of the clinical trial based on which generalizability of results can be decided.[6] The methodology section should have details about the study design, information regarding study control, type of blinding and method of randomization, time distribution of study events, endpoint variables, details about the proposed treatment, conditions under which study can be terminated and by whom, definitions of adverse events, methods to assess safety, permitted concomitant therapy, supplier for questionnaires and other forms, mechanism for systematic monitoring and documentation of the trial results, and adopted method of data analysis.[2],[6],[9] In addition, the protocol of clinical trials should have a clause that the identity of the study subjects and the obtained responses will be kept confidential.[1],[8],[9] Finally, the information regarding the authorship and the role of sponsors in the trial should also be disclosed.[3],[7]

To conclude, amidst the rising risks associated with the increasing number of clinical trials, the existence of a comprehensive protocol is a significant tool to monitor its progression and enhance the safety of the trial participants.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Subjects; 2006. Available from: http://www.icmr.nic.in/ethical_guidelines.pdf. [Last accessed on 2014 Jul 22].  Back to cited text no. 1
Cipriani A, Barbui C. What is a clinical trial protocol? Epidemiol Psichiatr Soc 2010;19:116-7.  Back to cited text no. 2
Betkerur J. Guidelines for writing a research project synopsis or protocol. Indian J Dermatol Venereol Leprol 2008;74:687-90.  Back to cited text no. 3
[PUBMED]  Medknow Journal  
Chowdhury N. Poor definitions threaten drug trial safety in India. Nat Med 2013;19:15.  Back to cited text no. 4
Srinivasan S. Patient protection in clinical trials in India: some concerns. Perspect Clin Res 2010;1:101-3.  Back to cited text no. 5
[PUBMED]  Medknow Journal  
WHO. A Practical Guide for Health Researchers – WHO Regional Publications Eastern Mediterranean Series 30. Geneva: WHO Press; 2004.  Back to cited text no. 6
The Ohio State University. Guidelines for Writing a Research Protocol; 2014. Available from: http://www.orrp.osu.edu/files/2011/10/GuidelinesforWritingaResearchProtocol.pdf. [Last accessed on 2015 Aug 01].  Back to cited text no. 7
Kaur S, Choy CY. Ethical considerations in clinical trials: a critique of the ICH-GCP guideline. Dev World Bioeth 2014;14:20-8.  Back to cited text no. 8
Mahaluxmivala N. Human subject protection in India – Is it adequate? Perspect Clin Res 2010;1:15-20.  Back to cited text no. 9
[PUBMED]  Medknow Journal  


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