Clinical Trials: A Brief Review

Authors

  • Sagade Vaibhav Research Scholar, Department of Pharmacy, Loknete Dadapatil Pharate College of Pharmacy, Mandavgan Pharata, Maharashtra, India
  • Kamble H Principal, Department of Pharmacy, Loknete Dadapatil Pharate College of Pharmacy, Mandavgan Pharata, Maharashtra, India.
  • Bhusari Vishwas M Research Scholar, Department of Pharmacy, Loknete Dadapatil Pharate College of Pharmacy, Mandavgan Pharata, Maharashtra, India.
  • Andhale Ashwini3 Asst. Professor, Department of Pharmacy, Loknete Dadapatil Pharate College of Pharmacy, Mandavgan Pharata, Maharashtra, India.

Keywords:

Clinical Trial, Pre-clinical, Phases, NDA, ICH, GCP.

Abstract

Clinical trials, according to the World Health Organization, are used to test new medicinal entities on humans after they have been studied in animals. Clinical studies are usually divided into five stages. Clinical pharmacologists study phase I pharmacokinetics, safety, and gross effects on human volunteers. If the drug passes the test, it moves on to phase II testing, where pharmacokinetics, safety, and therapeutic efficiency are studied on a small number of patients by clinical pharmacologists. If the test passes, hundreds of patients are studied by clinical investigators in phase III, primarily for safety and therapeutic effectiveness. If this passes, the medicine is now approved and available for sale. Even after the drug has been commercialized, physicians from numerous hospitals and clinics have sent their feedback on the drug, including ADR and efficacy in phase IV. The aim of this review paper is to compile the information regarding preclinical trials and clinical trial with future of the same.

References

Thorat SB, Banarjee SK, Gaikwad DD, Jadhav SL, Tharat RM. Clinical trial: a review. International Journal of Pharmaceutical Sciences Review and Research. 2010; 1 (2): 101–6.

Temple University. Clinical Trials. [Online] Available from https://medicine.temple.edu/depart

ments-centers/clinical-departments/department-emergency-medicine/emergency-medicine/resear

ch-programs-clinical-trials

Ratnadeep V Ghadage. Pharma tutor. (2011, Nov.), Brief review on Clinical Trials, [Online] Available Here https://www.pharmatutor.org/articles/review-on-clinical-trials-clinical-research-organization-phases-of%20-clinical-research

Wikipedia. (2022, Feb.) Clinical trial [Online]. Available from https://en.wikipedia.org/wiki/

Clinical_trial

Kulkarni S.K. Handbook of Experimental pharmacology,3rd edition Vallabh Prakashan New Delhi 2005, Page-21.

US FDA. (2018, March) E6 (R2) Good clinical practice: Integrated addendum to ICH E6(R1), Page No.18 [Online]. Available from https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

Tripathi KD. Essential of Medical Pharmacology. 7th ed. New Delhi: Jaypee Brothers; 2013.

Santosh Nagare, Clinical Trial-Present and Future. International Journal of Pharmaceutical Sciences Review and Research. 2020; 65 (2), 169–171.

Adhikari S. (2020, May.)What is Blinding in Research? What is its Types? [Online] Available from https://www.publichealthnotes.com/what-is-blinding-in-research-what-are-its-types/#:~:

text=Blinding%2C%20in%20research%2C%20mentions%20to,somehow%20influence%20the%20study%20findings.

Food and Drug Administration. Guidance for industry. Using a centralized IRB review process in multicenter clinical trials. Rockville, MD: FDA. 2006.

Garg GR, Gupta S, Review of the pharmacology 12th ed. New Delhi: Jaypee Brothers; 2018.

Chris F, Shawn H, Clinical trial-An Overview. Research Review Education Series. 2012.

Barar FSK. Essential of pharmacotherapeutics. Revised edition. S. Chand publication;1985.

Bourin M, Neurobiology of the mood the University of Nantes, Phase 3 clinical trials What Methodology. SOJ pharmacy and pharmaceutical sciences. 2017.

Viraj S, Phase 4 of drug development. Journal Indian society for Clinical research. 2010; 1: 4.

Mahan V. Clinical Trial Phases. International Journal of Clinical Medicine. 2014; 5:1374-1383.

ICH Harmonised Tripartite. (2016, Nov.) Guideline for Good Clinical Practice ‘Academy for Clinical Excellenge’ [Online]. Available from https://database.ich.org/sites/default/files/E6_R2_

Addendum.pdf

Orloff J, Douglas F, Pinheiro J, Levinson S, Branson M, Chaturvedi P, Ette E, Gallo P, Hirsch G, Mehta C, Patel N. The future of drug development: advancing clinical trial design. Nature reviews Drug discovery. 2009; 8 (12): 949–57.

Intelligent clinical trial, Deloitte Insights. [Online] Available from https://www2.deloitte.com/content/dam/insights/us/articles/22934_intelligent-clinical-trials/DI_In

telligent-clinical-trials.pdf

Downloads

Published

2022-03-23

Issue

Vol. 9 No. 1 (2022)

Section

Review Article

License

Declaration and Copyright Transfer Form

(to be completed by authors)

I/ We, the undersigned author(s) of the submitted manuscript, hereby declare, that the above manuscript which is submitted for publication in the STM Journals(s), is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere.

  • I/We will not withdraw the manuscript after 1 week of submission as I have read the Author Guidelines and will adhere to the guidelines.
  • I/We Author(s ) have niether given nor will give this manuscript elsewhere for publishing after submitting in STM Journal(s).
  • I/ We have read the original version of the manuscript and am/ are responsible for the thought contents embodied in it. The work dealt in the manuscript is my/ our own, and my/ our individual contribution to this work is significant enough to qualify for authorship.
  •  I/We also agree to the authorship of the article in the following order:

Author’s name                                    

 

1. ________________

2. ________________

3. ________________

4. ________________

 

We  Author(s) tick this box and would request you to consider it as our signature as we agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal.