Why is Clinical Research Becoming More Bureaucratic?

Mar 1, 2019 | Clinical Trials, GCP

Simon Rule and Steven LeGouill recently authored “Bureaucracy is strangling clinical research.” They note that despite no material change in the law or general GcP practices, there has been an exponential growth in the administrative burden, paperwork and regulation associated with clinical trials. Apparently, those involved at each and every stage demand more paper work for evidence, for quality and for results. But is it helping the clinical trials’ cause? Is this increase in regulatory-driven paperwork corresponding to greater, safer medicines? Follow the link to read the editorial in the BMJ Opinion.