Dear Deepak clinical trials anywhere are boon and we cannot cosider it as bane

yes it needs alot of preparations, communinications sometimes alot of obstacles but no gain without pain

Dear Deepak, its quite right that clinical trials are boon and not bane. but, current scenario as far as India is concerned, trials have become more stringent, absolutely no-go. you might be aware of verdicts against clinical trials going in SC. Kindly refer ACRO, you will find details there.

I deal extensively with various trial regulatory environments, including that of India [1-20]. Recent regulatory changes, especially the Notification No. GSR 72 (E) Rule (aka, "Drugs and Cosmetics (3rd Amendment") Rules of 2013, issued 8 Feb 2013 (I am working from the latest version registered in The Gazette of India, in Hindi and English) - although commendable, are primarily oriented to guard the safety of trial participants and to reform the much criticized (legitimately so) machinery of the Ethics Committees that have been demonstrated to exhibit widespread failure of function, obligation, and accountability in the trial regulatory process.

THE ETHICAL AND CLINICAL CHALLENGES OF TRIALS IN INDIA

This is much welcomed after over a decade of well documented ethical lapses [3-5; 10-16; 20], including:

- unethical collusions by - and the regulatory inefficacy of - the Central Drugs Standard Control Organization (CDSCO),

- lack of informed consent,

- inadequate protection from and compensation of clinical trial-related injuries and mortalities (numbering in the thousands),

- clinical trial protocols and guidelines violations including drug approvals without sufficient testing (letrozole being tested on young women for infertility despite overwhelming evidence that it is both embryotoxic and fetotoxic, with high risk of ovarian tumors, liver cancer, and atrophy of the reproductive tract), and

- multiple instances of what has been labeled after investigation as "gross violations of Indian law"

as indicted by the scathing - and scary - report from the Parliament of India’s Standing Committee on Health and Family Welfare (SCHFW), confirmed and reinforced in an extensive undercover investigation by NBC Dateline [13] here in the U.S., and now been investigated by the U.S. FDA. I am personally aware of hundreds and hundreds of ethical, regulatory, and legal violations over just the past decade. These trials have flagrantly violated the Indian Council of Medical Research’s (ICMR) Ethical guidelines for biomedical research on human subjects and the World Medical Association (WMA) Declaration of Helsinki: Ethical principles for medical research involving human subjects (the "Helsinki Declaration" of international law).

SOME REFLECTIONS ON SOLUTIONS

To the extent that imposing long overdue stricter ethical regulatory guidelines may lead to clinical trials that are better monitored and whose participants are finally receiving critical safeguards, that may improve the quality and objectivity of clinical trials in India, and inspire greater confidence in their results. But we must await the results of further investigations by several Government-mandated panels including additional findings from SCHFW expected to appear shortly to see whether we really arrive at some of the absolutely critical goals I have myself been long advocating, namely this "Ten Point Initiative For Clinical Trials Improvement in India":

1. Construction of an adequate firewall between industry and clinical trial investigators.

2. Removal or massive constraint of corrupt and/or inept contract research organizations. (CROs), essentially foreign middlemen who recruit patients, conduct tests, and analyze data (including the two notorious ones that reviewed a proposal generated by the NBC Dateline expose for the discontinued and discredited Vioxx, which both CROs were shamelessly and recklessly glad to move toward trial and approval!).

3. Assured independent monitoring of conformance of all clinical trial protocols to international recognized standards.

4. Assured diversity of trial populations to avoid the current practice of recruiting from poor homogeneous rural communities.

5. Greater education in clinical trial design, implementation, monitoring, data management, and quality assurance, and funding regulators especially in the Drug Controller of India (DCI) / Drug Control General India (DCGI) and the associated trial watchdog regulatory groups and entities.

6. Second-level monitoring and accountability of the Ethics Committees themselves to assure proper operation and arms-distance protocols.

7. Streamlining of, and improved cross-communication and cooperation between the fractured spectrum of overlapping agencies involved in the clinical trial process (the DCGI and CDSCO cited above, the Indian Council of Medical Research (ICMR), the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Standing Committee on Health and Family Welfare (SCHFW), among other key players.

8. Increase in the number of Government regulated and funded clinical trial centers with high-quality training in clinical research management and assurance.

9. Fostering of cross-country collaboration initiatives between clinical researchers and medical students in clinical research training, and their overseas counterparts and with overseas senior clinical trial investigators and experts.

10. New funding and training initiatives in translational science/medicine to facilitate the understand and bidirectional enrichment and cooperation between basic scientists and clinical researchers and practitioners, thereby also streamlining the bench to bedside process.

THE PROMISE

To my mind the real shame of the current clinical trial scene in India falls mainly on the wasted opportunities to empower a generation of gifted - often brilliant - young medical students, scientists and researchers (I know many personally) who are eager to contribute valuably to the advancement of medical science. India has an extraordinary pool of bright, insightful young medical talent who, I find, too often are given minimal guidance and mentorship, and even less financial support in their endeavors, a loss to all of us, as India could easily become a center of basic medical and clinical excellence, from which we all have a lot to learn as to new and different perspectives in medical thinking, with greater respect and emphasis for natural, not just pharmaceutical, solutions, thus opening up a true Evidence-based Integrative Medicine (eb-IM).

LOOKING FORWARD: INDIAN CLINICAL RESEARCH LEADERSHIP

I have great hope that by this year's end or shortly thereafter we will begin to finally see a new and reformed properly functioning clinical trial system in India that will join the international community of trial standards at the highest level of integrity [1,2;17;19]. Years may still be required to effect all reforms, but 2014 will see a tremendous move forward towards that goal. In addition, some great forward-looking initiatives are being implemented, such as INDOX (INDia–OXford) Cancer Research Network [6-8], a new partnership between the Institute for Cancer Medicine, Oxford University, and, now, 12 leading cancer centers in India, designed to improve the quality of clinical research and clinical trials in India, with some impressive progress to date (it began in 2005 and continues to be expanded to this day), and it is hope that Cross-Cultural Collaborative Clinical Research Initiatives with India (CCCCRII) which I have long been advocating will soon bring forth a day when clinical research in India becomes - as it promises to do so given its native human intellectual talent - an exemplar of innovative and progressive clinical therapeutics in current and emerging developments on the frontiers of medicine.

REFERENCES

1. Raina V. Doing cancer trials in India: opportunities and pitfalls. [Ann Oncol 2005; 16(10):1567-8.

2. National Cancer Registry Program (NCRP-ICMR). Two year report of the population based cancer registries 1999–2000; Bangalore: NCRP 2005.

3. Nundy S, Gulhati M. A new colonialism? Conducting clinical trials in India. N Engl J Med2005; 352: 1633–1636.

4. Sharma DC. Standard protocol helps improve ALL survival rates in India. Lancet Oncol2002; 3: 710.

5. Bagla P. Clinical research. India acts on flawed cancer drug trials. Science2001; 293: 2371–2373.

6. Developing innovative models for North–South cooperation in clinical research—experience from the INDOX Cancer Research Network. Ann Oncol (2008) 19 (5): 831-833.

7. Ali R, Finlayson A, Indox Cancer Research Network. Building capacity for clinical research in developing countries: the INDOX Cancer Research Network experience. Glob Health Action 2012; 5.

8. INDOX Cancer Research Network. http://indox.org.uk/.

9. Strengthening clinical research in India. Lancet 2007;369:1233.

10. Srinivasan S, Loff B. Medical research in India. Lancet 2006;367:1962-1964.

11. Maggon K. Regulatory reforms and GCP clinical trials with new drugs in India. Clin Trials 2004; 1(5):461-7.

12. Bhan A. Clinical trial ethics in India: One step forward, two steps back. J Pharmacol Pharmacother 2012; 3(2):95-7.

13. Rajalakshmi TK. Criminal Trials. [Last cited on 2012 Mar 10];The Frontline. 2012 Jan-Feb;29(2) Available from: http://www.frontlineonnet.com/fl2902/stories/20120210290203300.htm

14. Ghatwai M. Drug trials: Panel for stringent action, doctors fined 5,000 each. The Indian Express. 2012. Jan 2, [Last cited on 2012 Mar 10]. Available from: http://www.indianexpress.com/news/drug-trials-panel-for-stringent-action-doctors-fined-rs-5-000-each/894681/2.

15. Yee A. Regulation failing to keep up with India's trials boom. Lancet. 2012;379:397–8.

16. Jayaraman K. India mulling stricter laws to curb unethical trials. Nat Med. 2012;18:182.

17. Satyanarayana K, Sharma A, Parikh P, Vijayan VK, Sahu DK, Nayak BK, et al. Statement on publishing clinical trials in Indian biomedical journals. Natl Med J India. 2008;21:105–6.

18. ICMR Ethical Guidelines for Biomedical Research on Human Participants, ICMR. 2006.

19. Shetty YC, Marathe P, Kamat S, Thatte U. Continuing oversight through site monitoring: Experiences of an institutional ethics committee in an Indian tertiary-care hospital. Indian J Med Ethics. 2012;9:22–6.

20. Chattopadhyay S. Guinea pigs in human form: clinical trials in unethical settings. Lancet 2012 May 26; 379(9830):e53.