A physician-researcher at an academic institution is planning to study the effectiveness of a novel nerve stimulator device for chronic pain. The device will be tested as part of a large double-blinded, randomized clinical trial. The trial is funded partially by the device manufacturer as well as by grants from the federal government, which has identified nonpharmaceutical management of chronic pain as a high national research priority. The researcher has previously received payments from the device manufacturer for lectures about the device given at national conferences. The physician and support staff from the institution will be responsible for study design and implementation, and an academic researcher and biostatistician from the manufacturing company will oversee analysis of study results. Which of the following best describes the potential for conflict of interest (COI) generated by the manufacturer's involvement in the research?
Conflict of interest (COI) in clinical research can create an unconscious, favorable bias toward the investigational product (ie, drug or device being studied), compromising the validity of the results. Common sources of COI include the following:
Financial incentives (eg, stocks, speaking fees) to the investigator that are influenced by the study results or financial success of the investigational product
Using industry-sponsored personnel (eg, statistician) in study design or data analysis
Industry sponsorship of clinical research to cover investigator salaries and project expenses is common and alone does not constitute COI. However, factors in this case that may lead to COI include additional financial incentives to the investigator (eg, speaking fees) and use of industry-sponsored personnel in data analysis (Choice E).
To address these COIs, the institutional review board (IRB), a regulatory body that oversees clinical research, will likely require the investigator to disclose financial incentives to research subjects and analyze the research data by an independent analysis team before it approves the study. Ultimately, it is the responsibility of the principal investigator to comply with the recommendations from the IRB to mitigate or eliminate COI.
(Choice A) Disclosure of the investigator's financial compensation to potential subjects is appropriate but does not sufficiently mitigate this study's COI. The use of the manufacturer's personnel to analyze study results is highly likely to bias study results and should be avoided.
(Choice C) The magnitude of potential public benefit may influence availability of federal grants for clinical research but does not address COI. Rather, mitigation of COI in research is often required for continued funding of federal research.
(Choice D) Randomization and blinding can reduce bias in the data generated by the investigator during the trial. However, study design alone does not adequately mitigate bias introduced by use of industry-sponsored employees in data analysis.
Educational objective:
Incentivizing researchers based on product success and employing industry-sponsored personnel in data analysis generate conflict of interest (COI), which can compromise study results by creating a bias favoring the product under investigation. These COIs must be mitigated or eliminated before a study is approved by the institutional review board.