Dr. Jones is an investigator in a study testing a drug in human subjects for regulatory approval by the Food and Drug Administration (FDA). The study is a Phase II randomized, placebo-controlled, double-blinded study; that is, neither the investigator nor the subject know if the subject is receiving the drug or a placebo. The sponsor of the study is a large pharmaceutical company whose stock is publicly traded.
Dr. Jones has consulted for the sponsor of the study on the development of protocols for clinical studies of this or other products manufactured by the sponsor. She also serves on the sponsor's Scientific Advisory Board. For these services she has been paid $5,000. How would this potential conflict of interest be assessed?
In this situation, Dr. Jones has a financial interest in the sponsor of this study, albeit a small one. Since the study is randomized and blinded, some potential sources of bias have been minimized. However, other places where bias may be introduced are in the study design, recruitment of subjects, data analysis and reporting.
If this study were an earlier investigation of the drug manufactured by the sponsor, the importance of Dr. Jones' relationship with the sponsor would be different. Other circumstances would also influence our interpretation of this situation. Consider the following variations.
What if Dr. Jones also served on the Scientific Advisory Board for this company and received less than $10,000 a year for this service, plus received stock valued at around $100,000? Would this change your perception of a conflict of interest? Why?
What if this study was of a device invented by Dr. Jones and licensed by the University to the company, for which she also received royalty income? Would this change your perception of the conflict of interest? If so, why?
What if the company sponsoring this study was founded by Dr. Jones in order to test and market this device? What if it was a small, private company and this drug was the company's only potential product at this time? Would this change your perception of the conflict of interest? If so, why?
Conflicts of interest concern the potential effect on the objectivity of science or interference with or compromise of accepted academic values. The presence of a conflict of interest does not indicate that the investigator would, in fact, allow this conflict to influence his or her research results, delay publications, or otherwise affect the research. However, it does elevate the risk factor. Each of these scenarios presents factors that could compound this risk factor. If you had to assess this case and determine how to mitigate or manage the conflict, what would you choose for each scenario?
Assume that the investigator would do nothing that would compromise the objectivity of the research and allow the study?
Assume that the investigator would do nothing that would compromise the integrity of the research but take steps to manage the potential anyway in order to reduce the risk? If so, what would you choose?
Require that the investigator disclose his/her financial interest in publications or in public discussions of the research?
Require that the investigator terminate all consulting activities during the course of the study?
Require that the stock be sold prior to approving the study?
Remove the investigator from any or all of the following: patient recruitment and selection, treatment, data analysis?
Require the investigator be removed from the study?
Require that human subjects be advised of the investigator's financial interest prior to enrolling in the study?
Would your assessment be the same in each scenario? Might you feel different if you were the subject in this study?
What might the volunteers in this clinical study think about the investigator's financial interests? Could the possibility of bias in the outcome of the research harm their best interests in any way?
As you can see, there are no easy answers for assessing and managing conflicts of interest, but as these financial relationships, and thus the potential for a conflict of interest, become greater, Stanford must take steps to protect the science, as well as people who serve as human subjects in this study.