Research Clinical Trial- A Review
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Abstract
Majority of healthcare professionals are struggling with conducting and writing a protocol for a research study. Thus, the purpose of this article is to summarize significant steps and necessary guidelines for producing a standard research protocol, roles and responsibilities of various team members involved in the study, and conduction of actual clinical trial including its initiation, phases (I-III), termination or post-marketing surveillance phase. It is important to note that the quality of a clinical trial largely depends on the protocol to achieve success in the research study.
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References
I. World Health Organization. Clinical Trails: Questions and Answers; 2020. Available from: https://www.who.int/news-room/q-a-detail/clinical-trials
II. Vijayanathan, A, Nawawi O. The importance of Good Clinical Practice Guide and its Role in Clinical Trails. Biomed Imaging Interv Journal. 2008; 4(1).
III. Integrated Addendum to E6(R1): Guideline for Good Clinical Practice. 2016
IV. Ravinetto R. The Revision of the ICH Good Clinical Practice Guidelines: A missed opportunity? Indian J Med Ethics. 2017; 2(4): 255-9.
V. Cummings SR, Browner WS, Hulley SB, et al. Designing Clinical Research (3rd Ed.). Philadelphia: Lippincott Williams and Wilkins. 2007; 20-22.
VI. Riva JJ, Malik KMP, Ednicott AR, Busse JW. What is your research question? An introduction to the PICOT format for clinicians: Journal of Canadian Chiropractic Association. 2012; 56(3): 167-171.
VII. Guyatt G, Drummond R, Meade M, Cook D. The Evidence Based‑Medicine Working Group. Users’ Guides to the Medical Literature (2nd Ed.). Chicago: McGraw Hill. 2008
VIII. Lawrence M, Friedman, Curt D, et al. Fundamentals of Clinical Trials. 2015; pp 15-17
IX. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158:200–207.
X. Al-Jundi A, Sakka S. Protocol Writing in Clinical Research. Journal of Clinical and Diagnostic Research. 2016; 10(1): 10-13.
XI. Toronto Notes 2018 (34th Ed.).2018. pp PH11-13.
XII. WHO. Handbook for Good Clinical Research Practice (GCP): Principle 7- Informed Consent. pp 59-68.
XIII. Bogdan Ene-Iordache, EngD, Sergio Carminati, IT, et al. Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with The Demand Trial. Journal of American Medical Informatics Association. 2009; 16(3):404–408.
XIV. Toronto Notes 2018 (34th Ed.).2018. pp PH15.
XV. Speicher LA, Fromell G, Avery Sue, et al. The Critical Need for Academic Health Centers to Assess the Training, Support and Career Development Requirements of Clinical research Coordinators: Recommendations from the Clinical and Translational Science Aware Research Coordinator Taskforce. CTS – Clinical and Translational Science. 2012; 5(6): 470-475.
XVI. Mahan VL. Clinical Trial Phases. International Journal of Clinical Medicine. 2014; 5(21).
XVII. Alomar M, Tawfiq AM, Hassan N, et al. Post Marketing Surveillance of Suspected Adverse Drug Reactions through spontaneous reporting: current status, challenges and the future. Therapeutic Advances in Drug Safety. 2020; 11(1): 1-11