Dr. A.K. Singh, a professor of medicine, is a prominent cardiologist. His personal financial investments include significant stock holdings in three publicly traded biotechnology firms. He is approached by one of these firms to be a lead investigator in a therapeutic trial of a novel agent for preventing tissue damage from myocardial infarction (MI). This will be a randomized double-blinded, placebo-controlled clinical trial (neither patient nor physician will know whether the drug under investigation or a placebo is being used in a given patient). Dr. Singh is quite familiar with the preliminary animal and cell biology work in the area and believes that there is an excellent chance that this new drug will result in a significant improvement in survival and reduce damage to the heart muscle. He even thinks this novel agent may reduce the risk of heart failure and irregular beats. Dr. Singh's group is one of the few cardiology groups fully prepared to carry out this investigation, which is why he was contacted. He cares for a large number of patients with MI and believes that he could enroll numerous patients efficiently. The drug will only be available to his patients if his group participates in the trial. The company is offering Rs. 25 lakh for each patient enrolled. As a lead investigator, he will become much better known and will likely experience an increase in referrals if the trial succeeds. 1. Is Dr. Singh's participation in this study appropriate? Justify your position. 2. Does Dr. Singh have a conflict of interest? If so, what is the nature of the conflict? How could it be mitigated. 3. How would the nature of the conflict of interest be different had he not already owned stock, but instead had been offered stock as a form of compensation for conducting the study?

Answered by 3 toppers · CSE 2016–2018

Syllabus: Case Studies on above issues.