REGULATIONS GOVERNING CLINICAL TRIALS IN INDIA, EUROPE AND USA- A COMPARATIVE STUDY

  • Pooja Agarwal
  • Priyanka B.

Abstract

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it is harmful. However, an approach that works well in the lab or animals does not always work well in people. Thus, research in humans is needed.

Keywords: Clinical trials, humans, Phase 1, research, standards.

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References

1. Clinical Trial Phases [Internet]. International Journal of Clinical Medicine; 2014 [Cited 2017 Jan 14]. Available from:
http://www.scirp.org/journal/ijcmhttp://dx.doi.org/10.4236/ijcm.2014.521175
2. Clinical Trials [Internet]. PubMed Health [Cited 2017 Jan 12]. Available from:
https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0063029/
3. F. Hoffmann-La Roche Ltd GPS Public Affairs. Understanding clinical trials [Internet]. Basel, Switzerland. [Cited 2017 Feb 11]. Available from:
http://www.roche.com/dam/jcr:1d4d1b52-7e01-43ac-862f17bb59912485/en/understanding_clinical _trials.pdf
4. Tharani R. An Introduction to Clinical Trial Regulatory Agencies in India [Internet]. [Cited 2017 Feb 12]. Available from:
http://www.pharmainfo.net/book/clinical-pharmacy /introduction-clinical-trial-regulatory-agencies-india
5. European Medicines Agency – Science Medicines Health. [Internet]. [Cited 2017 Feb 04]. Available from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp
6. European Commission - Medicinal Products for Human Use. [Internet]. [Cited 2017 Feb 16]. Available from:
https://ec.europa.eu/health/human-use/clinical-trials/regulation_en
7. Sherwood, Ted. "Generic Drugs: Overview of ANDA Review Process" [Internet]. CDER Forum for International Drug Regulatory Authorities. [Cited 2017 Feb 08]. Available from:
https://oig.hhs.gov/oei/reports/oei-04-07-00280.pdf
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How to Cite
Agarwal, P., and P. B. “REGULATIONS GOVERNING CLINICAL TRIALS IN INDIA, EUROPE AND USA- A COMPARATIVE STUDY”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 1, Feb. 2018, pp. 30-39, doi:10.22270/ijdra.v5i1.195.