This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery. Financial conflicts of interest on the part of sponsors and investigators, and their potential impact on human subjects, is an area that is becoming increasingly complicated at the same time that it's becoming a more visible and carefully scrutinized part of the process. The purpose for this conference is to not only consider approaches that are being used at present to manage financial conflicts of interest at the level of the institution, the IRB, and the clinical investigator, but also to see if there are additional ideas and actions we need to consider. These deliberations will be helpful to any refinements our guidance requires to ensure existing disclosure and conflict of interest regulations are effective, patients protected, and interpretation of research data as bias-free as possible.
Clinical trials play a vital role in new product development.
For it is through this mechanism that data are generated to support the safety and efficacy of products and technologies that will improve patients' well-being, ease suffering, extend lives or improve quality of life. In making many of its review decisions on new products, particularly pharmaceuticals and biologics, FDA relies on data regarding safety and effectiveness that have been generated by clinical trials. It should be obvious that the quality of decisions FDA makes relies heavily on the integrity of the data submitted. That means that every part of the clinical trial process has to be above reproach-from trial design, to recruiting the appropriate population of subjects, to obtaining adequate informed consent of human subjects, to unbiased interpretation of the resulting data. The protection of human subjects who participate in research is fundamental.