An unfortunate trend that is emerging in the global pharmaceutical industry is the growing number of frauds in clinical research. Frauds never used to be known in the past but quite a few cases are coming out in the public now. Clinical trials is the final stage in the development of a new drug candidate and granting of marketing approval for it depends on the safe trial reports the companies submit to drug control authorities. Trial reports should not, therefore, indicate serious adverse drug reactions of the new drug. With the global pharma industry finding it extremely tough to get a new drug molecule from research for some years, even some of the top companies do indulge in submitting falsified research reports. The most recent revelation in this regard is about Dr. Scott Reuben, a former member of Pfizer Inc' s speakers' bureau. He had agreed to plead guilty to faking dozens of research studies that were published in international medical journals. Another case is that of Avandia of GSK. The recently released US Senate committee report has uncovered that GSK concealed information that the diabetic drug caused tens of thousands of heart attacks in patients who took it. The 334-page report also indicts the US Food and Drug Administration for failing to properly regulate the drug and ignoring the truth about its dangers.
Human trials, usually, are highly secretive as it involves deaths or serious injuries to the subjects during the course of trials. Details of such deaths and injuries during trials are unknown and quite often suppressed by CROs and pharma companies for submitting a clean trial report. Introduction of a comprehensive regulatory system for conduct of clinical trials should, therefore, adequately consider such possible excesses by the pharmaceutical companies. Developing and incorporating systems for detecting and preventing fraud should be part of any standard compliance plan of clinical research programme. It is necessary to evolve a system to detect how fraudulent acts are committed and presented in clinical trials. Ethics Committee in each trial site has a decisive role to play here. Study of recent cases of fraud in clinical research and how regulatory agencies and clinical research industry responded to such cases would be vital. Methods of detecting and reporting suspect clinical data should necessarily be developed for this by drug control authorities. In India, although a set of rules for clinical research has been finalized by ICMR long back, provisions relating to possible frauds in clinical research, its detection and reporting do not seem to be incorporated.