Clinical research in India: Great expectations?

Journal of Postgraduate Medicine

Volumn 54, Issue 4, 2008, Pages 318-323

  Thatte, U ^a   Bavdekar, S ^a  

^a KEM HOSPITAL   (India)

Author keywords

Bioethics; Clinical trial; Research ethics

Indexed keywords

BIOETHICS; CLINICAL PRACTICE; CLINICAL RESEARCH; HEALTH CARE MANAGEMENT; HEALTH CARE ORGANIZATION; HEALTH CARE PERSONNEL; HUMAN; INDIA; MEDICAL EDUCATION; PATIENT CARE; REVIEW; SAFETY; SOCIAL ASPECT;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES; ETHICS, MEDICAL; HUMANS; INDIA; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RESEARCH SUPPORT AS TOPIC; SAFETY;

EID: 55549089312     PISSN: 00223859     EISSN: None     Source Type: Journal    
DOI: 10.4103/0022-3859.43517     Document Type: Review

References (26)

1. Confederation of Indian Industry. Background Paper. Conference on Clinical Research: Roadmap for India, New Delhi: 2003 Sep 24-25.
2. Kamath G, Krishnan GS. Trial and error. Mumbai: Business World; 2007. p. 20-8.
3. Nundy S, Gulhati CM. New colonialism? Conducting clinical trials in India. N Engl J Med 2005;352:1633-6.
4. Varma S. India a hotbed for clinical trials. Available from: http://timesofindia.indiatimes.com/articleshow/1776215.cms [last accessed on 2008 Mar 6].
5. Srinivasan S. Clinical Trials - Part I: Open house on drug trials in India. Available from: http://www.infochangeindia.org/features302.jsp [last accessed on 2008 Mar 6].
6. Tufts Center for the Study of Drug Development. Outlook 2007. Available from: http://csdd.tufts.edu/InfoServices/Outlook PDFs/Outlook2007.pdf [last accessed on 2008 Jan 1].
7. Mehdiratta R, Parida DK, Saberwal G. Bio-business in brief: The challenges of clinical trials. Curr Sci 2007;93:1367-75.
8. Sinha K. India overtakes China as a no. 1 destination for clinical trials. Available from: http://timesofindia.indiatimes.com/ India_overtakes_China_as_no1_destination_for_clinical_trials/articleshow/ 2927126.cms [last accessed on 2008 Apr 20].
9. Schedule Y. Requirements and guidelines for permission to import and/ or manufacture of new drugs for sale or to undertake clinical trials. Available from: http://www.cdsco.nic.in/html/Schedule-Y%20(Amended%20Version-2005) %20original.htm.
10. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on human participants 2006. Available from: http://www.icmr.nic.in/ ethical_guidelines.pdf. [last accessed on 2008 Mar 6].
11. iGate Clinical Research International. The India advantage. Available from: http://www.igate.com/icri/html/aboutus/tia.htm. [last accessed on 2008 Jun 19].
12. Saktivel S. Access to Essential Drugs and Medicine in National Commission on Macroeconomics and Health Background Papers-Health Systems in India: Delivery and Financing of Services; Section III, p. 158-84.
13. Clinicaltrials.gov. Available from: http://clinicaltrials.gov/ct2/search/ browse?brwse=locn [last accessed on 2008 Jun 23].
14. European Medicines Agency. ICH Topic E 6 (R1) Guideline for Good Clinical Practice. Available from: http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf
15. Sinha K, Singh MK. India short of 6 lakh doctors. Available from: http://timesofindia.indiatimes.com/articleshow/2921262.cms [last accessed on 2008 Apr 20].
16. Raaj N, Nagraj NN. Shortage of doctors puts healthcare system on life support. Available from: http://timesofindia.indiatimes.com/Opinion/ Sunday_Specials/Shortage_of_specialists_puts_healthcare_on_life_support/ articleshow/2947856.cms [last accessed on 2008 Apr 20].
17. Perneger T, Ricou B, Boulvain M, Bovier P, Herrmann F, Perrier A, et al. Medical researchers evaluate their methodological skills. J Clin Epidemiol 2004;57:1323-9
18. Accountability in clinical trials (Editorial). Available from: http://www.hindu.com/2006/08/01/stories/2006080102830800.htm [last accessed on 2008 Jan 1].
19. Joshi S, Solomon S, Mayer K, Mehendale S. Preparing for efficacy trials of vaginal microbicides in Indian women. Indian J Med Res 2005;121:502-9.
20. Thatte UM, Kulkarni RA, Kalekar SA. Review of policies for injuries to research participants in India. In: Conference Publication. First Annual Conference of Indian Society for Clinical Research in India, Mumbai: Indian Society for Clinical Research; 2008. p. 14.
21. Sahay S, Mehendale S. Addressing ethical concerns in the Indian HIV vaccine trials. Indian J Med Educ 2004;1:109-12.
22. Saktivel S. Access to Essential Drugs and Medicine. In: National Commission on Macroeconomics and Health Background Papers-Health Systems in India: Delivery and Financing of Services; Section III, p. 158-84.
23. Sung NS, Crowley WF Jr, Genel M, Salber P, Sandy L, Sherwood LM, et al. Central challenges facing the national clinical research enterprise. JAMA 2003;289:1278-87.
24. Sen F, Muthuswamy V. Capacity building for clinical trials in India. Indian J Med Res 2006;124:605-7.
25. National GCP Workshops. Available from: http://cdsco.nic.in/html/firtgcp. pdf. [last accessed on 2008 Mar 6].
26. Indian Council of Medical Research. Bioethics Education in India. Available from: http://www.icmr.nic.in/bioethics/cc_biothics/index.html [last accessed on 2008 Mar 6].