“Patients and the public benefit when physicians and researchers collaborate with pharmaceutical, medical device, and biotechnology companies to develop products that benefit individual and public health. At the same time, concerns are growing that wide-ranging financial ties to industry may unduly influence professional judgments involving the primary interests and goals of medicine”4 When a site is successful, the sponsor will sometimes employ the principal investigator (PI) or request that they perform tasks outside of the clinical trial they participated in. Tasks can include traveling to train physicians, speaking on their experience with the drugs or devices at conferences, or writing articles for industry publications. The impact of the conflicts of interest (COI) related to these “extracurricular activities” is significant. It is becoming more apparent that discussions about COI need to occur more often than the standard frequency (bi-annually). The potential impact of this growing trend on investigator COI at the site can be shocking when sponsors employ investigators without the site’s knowledge.
Federal regulations, state laws and facility policies recognize that researchers may have financial interests in research sponsors and/or in entities with business interests closely related to their research. The term “conflict of interest in research” refers to situations in which financial or other personal considerations may compromise or have the appearance of compromising a researcher’s professional judgment in conducting or reporting research1. A COI arises mostly out of investigators’ relationship with the sponsor. The most obvious examples of COI include investigators who have relationships that could lead them to benefit financially or commercially from the outcome of a trial.
The mere presence of a COI does not necessarily mean impropriety. COI occurs in many professions but is especially serious in medical practice and medical research as a patient’s life is often at stake. A patient may feel differently about participating in a clinical trial if the PI is a stakeholder in the company or is being compensated by the sponsor beyond the clinical trial. However, if a COI is detected or declared in time, impropriety can be prevented or at least its impact minimized. As per the good clinical practice (GCP) guidelines of the International Conference on Harmonization (ICH), the health and medical care of participants is the responsibility of the investigator, hence any COI of the investigator is a risk for the participant2. There are steps sites can take to identify the COI, report it, and ensure the participants are aware and informed of the COI.
The Physician Payments Sunshine Act, or “Sunshine Act”, is designed to bring transparency to financial relationships between physicians, teaching hospitals, and the pharmaceutical industry. This law requires manufacturers of pharmaceutical drugs and devices, as well as group purchasing organizations, to report payments or transfers of value (such as meals, honoraria, or travel reimbursements) made to U.S. physicians and teaching hospitals. It also requires the paying company to report physicians who have an ownership interest in the company. Reports are made to the Centers for Medicare and Medicaid Services (CMS), a government agency3. Potential subjects are able to view this information online to assist them in the informed consent process and in making an educated decision regarding their participation. Typically, a review committee will assess the COI and consult with the physician or employee to come up with a suitable management plan. This helps inform potential subjects of the researcher’s conflict and hopefully eliminate any chances of undue influence.
Depending on the nature of the research that is performed at the site, sponsors frequently ask investigators to proctor or train other investigators or users across the country. As a result, they are compensated for a variety of activities that need to be reported as part of the Sunshine Act. If an investigator reports over $5,000 in reportable items from any company, this must be documented.
Significant COIs could potentially affect the integrity of scientific investigations, the quality of patient care, and the public’s trust in medicine. It is in the site’s best interest to ask questions, pay attention, and continually identify COIs to ensure the consistent quality of clinical trials being conducted at sites.
Note: This article originally appeared in the Summer, 2018 edition of SCRS Insite: The Global Journal for Clinical Research Sites.
The Regents of the University of California, Office of Ethics and Compliance. Conflict of Interest in Research. 2013. Accessed May 2018 from: http://coi.ucsf.edu/
Ghooi, R.B. Conflict of interest in clinical research. Perspect Clin Res. January-March 2015. Accessed May 2018 from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4314841/
Physician Payments Sunshine Act. American Society of Clinical Oncology. 2015. Accessed May 2018 from: http://www.asco.org/about-asco/physician-payments-sunshine-act-0
Lo, B, & Field, M.J. (Eds.) Conflict of Interest in Medical Research, Education, and Practice, National Academy of Sciences. 2009. Accessed May 2018 from: http://www.ncbi.nlm.nih.gov/books/NBK22942/
About the Author
Nicole Mills is a Clinical Research Field Specialist with Medix and currently works in our Scottsdale, Arizona office.