Misconduct and Key Risk Indicators in the Pharmaceutical Industry
Misconduct or fraud is a widespread issue in many spheres, including the pharmaceutical industry. One reason for that is the heavily regulated nature of the industry, meaning that key actors possess significant power. Apart from that, the pharmaceutical industry combines business and scientific interests, creating a considerable potential for misconduct in both areas. Misconduct as related to business affairs may take the form of deliberately misinforming shareholders or other stakeholders. As for scientific misconduct, it often takes the form of fabrication or falsification of research results (Wajman, Marin, Bertolucci, Chaves, & Bromley, 2018). Since monitoring each site continuously is too resource-consuming, preventing such possibilities requires identifying industry-specific key risk indicators for misconduct.
While specific key risk indicators in the pharmaceutical industry depend on the organization in question. It is possible to identify some of the most prominent ones that can be of use in different situations. In terms of business misconduct, the rate of serious adverse events reporting may be of use (Valdés-Márquez, Hopewell, Landray, & Armitage, 2011). Speaking of scientific misconduct, one should look for statistical deviations in the results detecting potential data fabrication or the duration of a study treatment visit to identify potential corruption (Valdés-Márquez, Hopewell, Landray, & Armitage, 2011). Such key risk indicators would not suffice on their own to detect misconduct with certainty, but they would be enough to identify sites and areas for more rigorous checking and inspection. As such, this list is definitely not exhaustive, but it still contains some general suggestions of key risk indicators one should consider in the pharmaceutical industry.
Valdés-Márquez, E., Hopewell, C. J., Landray, M., & Armitage, J. (2011). A key risk indicator approach to central statistical monitoring in multicentre clinical trials: method development in the context of an ongoing largescale randomized trial. Trials, 1(12, Supplement 1). A35.
Wajman, J. R., Marin, C. M. C., Bertolucci, P. H. F., Chaves, M. L. F., & Bromley, T. (2018). Qualitative features in clinical trials: coordinates for prevention of passive and active misconduct. International Journal of Clinical Trials, 5(1), 2349-2359.