Exhibit 3Example of limited availability of clinical expertise in the field

An SR of a condition that affects fewer than 4,000 individuals in the country is conducted. The condition is debilitating if not treated, and a new drug has been approved, based on two fairly small randomized controlled trials. Other drugs are in the pipeline and early research is available on some compounds. The pharmaceutical company that produced the drug funds almost all research in the field and their scientists are major players at scientific meetings. All patients are treated at a limited number of specialist clinics, mostly at academic centers. All clinics are engaged at some level of research, at minimum by enrolling patients in the drug trials. The community of scientists engaged in this work and seeing patients is very small and they all know one another. They are all aware that, as researchers of a rare disease, their access to government funding is challenging, and they feel a strong solidarity based on their perceived lack of attention in the larger clinical research arena. They also serve as strong advocates for their patients, and the family advocacy groups are very connected to the researchers. The SR team includes a clinical staff person who runs a clinic caring for patients with the condition. This individual is the only team member available with direct clinical experience, and has important expertise in a complicated clinical condition, but because all clinics are enrolling patients in the drug trials, the staff member’s name may appear in drug company publications about the drug being reviewed. This individual is salaried and his/her career does not depend on research productivity, but it is possible that the inclusion of the name on the report and on publications related to clinical trials funded by the pharmaceutical company could trigger letters to the editor casting doubt on the SR’s objectivity.

From: Identifying, Measuring, and Managing NFCOI

Cover of Identifying and Managing Nonfinancial Conflicts of Interest for Systematic Reviews
Identifying and Managing Nonfinancial Conflicts of Interest for Systematic Reviews [Internet].
Viswanathan M, Carey TS, Belinson SE, et al.

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