The US FDA has released a guidance titled ‘Oversight of Clinical Investigations A Risk-Based Approach to Monitoring’ to the clinical research organisations. The guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof.

The key objective of these rules are to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.

This guidance makes clear that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring clinical investigator (CI) conduct and performance in investigational new drug (IND) studies conducted under 21 CFR part 312 or investigational device exemption (IDE) studies conducted under 21 CFR part 812. It reflects a modern, risk-based approach on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. It specifically encourages use of centralized monitoring methods.

“Effective monitoring of clinical investigations by sponsors is critical to the protection of human subjects and the conduct of high-quality studies. Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data,” said the regulatory authority.

In the last two decades, the number and complexity of clinical trials have increased. It has created  new challenges to clinical trial oversight, particularly increased variability in clinical investigator experience, site infrastructure, treatment choices, and standards of health care, along with issues related to geographic dispersion.

At the same time, increasing use of electronic systems and records and improvements in statistical assessments, present opportunities for alternative approaches like  centralized monitoring which enhances quality and efficiency of sponsor oversight of clinical investigations.

Now the regulator supports sponsors to develop monitoring plans that manage important risks to human subjects and data quality to  address the challenges of oversight in part by taking advantage of the innovations in modern clinical trials. A risk-based approach to monitoring does not suggest any less vigilance. Rather, it focuses sponsor oversight activities on mitigating important and likely risks to data quality processes critical to human subject protection and trial integrity. Moreover, a risk-based approach is dynamic, more readily facilitating continual improvement in trial conduct and oversight. For instance, monitoring findings should be evaluated to determine whether additional actions like training of clinical investigator and site staff, clarification of protocol requirements are necessary across sites.

This guidance focuses principally on monitoring, which is one aspect of the procedures needed to ensure clinical trial quality and subject safety. Monitoring is a quality control tool to determine if the clinical trials is carried out methodically. However, the US FDA has stated that monitoring, or oversight, alone cannot ensure quality. Rather, quality is an overarching objective that must be built into the clinical trial enterprise.

The guidance encourage sponsors to consider a change in approach to monitoring. Risk-based monitoring could improve sponsor oversight of clinical investigations, said the regulatory authority.