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India A High Risk Country for Misconduct in Clinical Research I) Introduction Clinical Research is a scientific discipline wherein numerous data is getting generated in different location on a daily basis. There are various players who are responsible for the generation of these data. Moreover, these data do influence the decision of the sponsor and the regulatory authority in commercializing the tested product. It is significant to note that the data that is getting generated can be genuine or fraudulent and therefore will have an impact on the wellbeing of the society. The way and the manner in which the clinical trials are being conducted will have to be taken into serious consideration by each and every professional in the Clinical Research industry. The point of discussion of this article is that, whether India is a high risk country for misconduct in Clinical Research or not. When we mention misconduct, it is an “intentional wrongdoing” and in the case of fraud it is a “willful deception”. Does India carry out intentional wrongdoing in the field of Clinical Research, a question to be answered by the professionals working in CRO and Pharmaceutical Industry in India? It is true that India is an important destination for clinical trials but we can’t deny the fact that it is one of the most vulnerable countries for the fraud and misconduct. The reason why India is a leading destination for conducting Clinical Research is enumerated below: II) Resource advantage 1) Investigators Large No. of specialists and super specialists in the field of science and research English trained medical professionals PG trained physicians from Europe/US Large no. of ICH/GCP trained individuals 2) Patient population Large, Diverse, therapy Advantage of having 6 out of 7 genetic varieties Large amount of patient pool in acute/chronic disease segment Increase in no. of cases like AIDS and cancer


3) Clinical Research Infrastructure Over 200 Medical Colleges Over 22,000 graduates per year 15,622 hosp., 903,952 hosp.beds >75% in urban area 14000 diagnostic labs 700,000 scientists and engineering graduates / year World class medical / lab facilities 4) IT Support Highly developed IT / ITES Motivated & committed personnel 5) Connectivity High quality digital connectivity Excellent transport facilities across country

III) Number of Clinical trials from India:(www.clinicaltrials.gov; 15 Apr08)

Clinical Trials PHASE 1 PHASE II PHASE III PHASE IV

No. Of clinical trials from India 32 165 394 63


IV) Who is responsible for the fraud? This includes • Sponsor or CRO, • CRAs, • Investigators and • IRBs or ethics committees. It’s not just the matter that who has been involved in the fraud but it’s the matter of negligence which can affect the lives of many innocent consumers. In the clinical trial most of the activity is often delegated by the Principal investigator to the CRC or nurses .Many trials involve a regular dose of medication in which the patient will come to the investigator for administration of this product. A doctor will often examine the patient for serious side effects and leave it up to a nurse to administer the medication, although many of these nurses are very competent. However, nobody is perfect which can sometimes lead to the fraudulent activity. Many companies offer recruitment incentives to doctors involved in studies, as they get more patients into the studies, the doctor receives more money. The main problems associated with recruitment incentives will cause a physician conflict of interest as a result of which doctor might recruit the subject that may not fit for the specific trial


Conflict of interest has been defined as “a discrepancy between the personal interests and the professional responsibilities of a person in a position of trust” (Orlowski and Wateska, 1992). V) Why India A High Risk Country for Misconduct 1) Sites • Low awareness of regulations, ethics and GCP amongst investigators, CRC,CRA and ethics committees • Lack of proper system to document the data • Scarcity of trained research staff 2) Sponsor • Dual quality in clinical trials – local vs. MNC • Unnecessary focus on speed rather than focusing in quality and integrity of trial 3) Regulators • Lack of system of inspections and review procedures. • Lack of awareness • Lack of proper Guidelines VI) Why Fraud in India:There is a school of thought, which says that the reason for misconduct in India is due to lack of regulation, lack of transparency and accountability. In 2006, WEMOS and the Centre for Research on Multinational Corporations prepared an overview and found that out of 22 unethical cases around the world, 8 cases are from India. The Indian examples of illegal and unethical trials  Sun Pharmaceuticals and Novartis’s Letrozole for inducing ovulation when approved only for breast cancer,  Novo Nordisks for diabetes treatment,  Solvay Pharmaceuticals for treating diarrhea,  Johnson and Johnsons for treating acute malaria,  Pfizer’s for cardiac events,  Otsukas for arterial disease,  Indian companies Shantha Biotechnics and Biocon for diabetes and  John Hopkins University’s trials for treating oral cancer


In recent years, India has made some regulatory attempts,    

Amending its drugs and cosmetics act Good clinical practices (GCP) guidelines The ethics committee that the ICMR has formulated. But there is still no compulsory compensatory payment, or penalty against the defaulting company. „‟Ethics awareness in India is developing and the law superseding, but still there is deficiency in working out solutions for improving the act of fraud and misconduct

VII) Dealing with Misconduct • Prevention Identify and eliminate risk factors for misconduct • Detection Increasing the period of monitoring and auditing can help detecting the fraud • Correction Promptly investigate and report fraud and try to correct them as soon as possible to reduce the deviation from the truth VIII) Conclusion Even if a new product doesn't work or we don't know how it works, there is pressure on managers to get it reviewed and approved. The Clinical trial process takes up a lot of time and money on the part of the sponsor. Often the company has high hopes for a specific product that in reality the product just may not meet. No company wants to invest all of the required money for the trials if they are not going to make a profit from it. As a result there may be more fraudulent activity, even when the product has been reviewed and approved. In order to improve these fraud and misconduct, it is essential that has the broader objective that is overall well being of the society.

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Misconduct in Clinical Research