Similarities and Differences Between Clinical Trials of Drugs and Clinical Trials of Vaccines
DOI:
https://doi.org/10.56450/JEFI.2025.v3i04.003Keywords:
Clinical trials, Drug development, Vaccine development, Regulatory framework, Public health, IndiaAbstract
Background: Clinical trials are central to the development of drugs and vaccines; however, therapeutic, and preventive products differ substantially in objectives, populations, endpoints, and regulatory expectations. Aim & Objectives: To critically compare similarities and differences between drug and vaccine clinical trials, with special reference to the Indian regulatory and public health framework. Methodology: A structured narrative review was conducted using PubMed/MEDLINE, Scopus, Web of Science, Cochrane Library, WHO IRIS, CDSCO, ICMR, FDA, and EMA sources (2000–2025). Seventy-three eligible publications were included after screening 480 records. Comparative domains included trial phases, endpoints, safety monitoring, ethics, regulatory scrutiny, and post-marketing systems. Results: Both trial types follow phased development, Good Clinical Practice, ethics oversight, and regulatory approval pathways. However, vaccine trials differ in enrolling predominantly healthy populations, emphasizing immunogenicity and population-level effectiveness, requiring larger sample sizes, stricter safety thresholds, and enhanced community engagement. In India, NDCTR-2019, CTRI registration, PvPI, and AEFI frameworks create differentiated yet complementary surveillance mechanisms. Conclusion: While drug and vaccine trials share methodological foundations, vaccines operate within a broader public health governance paradigm. Strengthening integrated surveillance, adaptive regulatory pathways, and ethical harmonization is essential for future therapeutic and preventive innovation.
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References
1. World Health Organization. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Geneva: WHO; 2016. Available from: https://apps.who.int/iris/handle/10665/43392
2. Indian Council of Medical Research. National ethical guidelines for biomedical and health research involving human participants. New Delhi: ICMR; 2017. Available from: https://ethics.ncdirindia.org/ICMR_Ethical_Guidelines.aspx
3. Central Drugs Standard Control Organization. New Drugs and Clinical Trials Rules, 2019. New Delhi: Ministry of Health and Family Welfare, Government of India; 2019. Available from: https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/New-Drugs-and-Clinical-Trials-Rules-2019/
4. U.S. Food and Drug Administration. The drug development process. Silver Spring (MD): FDA; 2023. Available from: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
5. European Medicines Agency. Guideline on clinical evaluation of vaccines. Amsterdam: EMA; 2018. Available from: https://www.ema.europa.eu/en/clinical-evaluation-vaccines
6. Plotkin SA, Orenstein WA, Offit PA, Edwards KM. Plotkin’s vaccines. 7th ed. Philadelphia: Elsevier; 2018.
7. Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of clinical trials. 5th ed. Cham: Springer; 2015.
8. Ministry of Health and Family Welfare. Universal Immunization Programme. New Delhi: Government of India; 2023. Available from: https://www.mohfw.gov.in
9. Lahariya C. Vaccine development, manufacturing and regulation in India: issues and challenges. Indian J Med Res. 2014;139(3):427-435. Available from: https://pubmed.ncbi.nlm.nih.gov/24718485/
10. World Health Organization, India Country Office. Adverse events following immunization (AEFI) surveillance system in India. New Delhi: WHO India; 2022. Available from: https://www.who.int/india/health-topics/immunization
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Copyright (c) 2025 Shankar Prasad Bhattacharya (Author)
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