<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Relations to Industry Super Pharmaceuticals has been conducting a randomized double-blinded study of a revolutionary new treatment for osteoporosis at a major teaching hospital for the past 3 years; Dr. Miller is a major stockholder in the company and has been PI of this project at the hospital. He has 200 women over the age of 65 enrolled and he is enthusiastic about the drug. At the annual stockholders meeting the company disclosed positive findings, making the stock soar. In a meeting with his Clinical Trials Coordinator Dr. Miller learns that two women in the study have developed a dilational cardiomyopathy. Dr. Miller informs the Data and Safety Monitoring Board, Super Pharmaceuticals and his institution's IRB of the SAE (serious adverse event). The Data and Safety Monitoring Board reviews the data and reports simply that the study should continue because they believe the cardiomyopathy could not be clearly related to the drug. They send that report to the IRB and FDA. They do not require informing current and future study patients, or amending the protocol or Consent document. Questions: What are the issues in this case? Is the institution at any risk here? What do you believe the response should be to the serious adverse events? How would you feel if Dr. Miller were studying mostly his own patients? Were there any explicit or potential issues that might have affected initial approval of the study? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 5 Quick Links Monitor Research Cases Bibliography Chapter 5 Download (PDF)