Policy Change to Adequately Address Monitoring Conduct in a Risk-Based Environment

In the new Risk-Based (RB) environment of clinical trials, policy to prevent and address misconduct and fraud by Clinical Research Associates (CRA) is virtually nonexistent. To date, misconduct of CRAs and its potential cost to patients and sponsors has not been studied, and thus, has not been addressed. Through strong policy change, it is time for regulators to voice a firm stance that misconduct and fraud will not be tolerated by any member of the scientific community. Traditionally, onsite monitoring has been the standard for quality control with its emphasis placed on Clinical Research Site (CRS) conduct. Quality Assurance (QA) audits retrospectively sample CRS work-product for any possible mistakes or misconduct missed during the monitoring process. There are no regulated standards for how onsite monitoring visits are conducted, during which there is very little oversight of CRAs. Misconduct and fraud by CRAs is not well documented in the literature or in FDA guidance, and with the adoption of Risk-Based Monitoring (RBM) methods, there will be far less oversight of CRAs creating room for their potential misconduct and fraud. The resulting financial cost to sponsors, and risk to patient safety and rights, cannot yet be estimated. Regulators must make confronting CRA misconduct a priority.