How do the key stakeholders interact with RBM?

Research Sites

One of TransCelerate’s primary strategic priorities is to improve the site investigator experience. While Monitoring Plans are enacted by the pharmaceutical company or Clinical Research Organization running the trial, the site plays a critical role in enabling the plan and process.

Both On-site and Off-site monitoring are important to RBM – but with the TransCelerate model relying more heavily on remote activities, it’s crucial that sites have solid relationships and communication with the sponsor company throughout the trial lifecycle.

Research sites have varying levels of experience, quality and technology available to them. Previously, sponsors used a “one-size-fits-all” approach to monitoring. Now, those varying levels are taken into consideration when developing a Monitoring Plan – which benefits the site by being tailored to its attributes, performance and needs.

As RBM evolves and industry knowledge and experience deepens, sites’ use of technology, training and data-collection will also likely evolve. This will benefit the industry at large by modernizing investigator site capabilities in a clinical trial.

Regulatory Authorities

In 2011, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Health Products Regulatory Agency (MHRA) released guidance papers on RBM, showing their support of the practice, and recognizing some of the mounting concerns attached to clinical trials.

In 2013, the FDA issued additional guidance on RBM, this time declaring its ability to better ensure subject safety and study quality compared with On-site and SDV approaches. The FDA wrote that the volume of challenges to clinical trial oversight – particularly increased variability in clinical investigator experiences – combined with new technologies, present opportunities for new monitoring approaches.

By endorsing new monitoring approaches, the FDA is helping propel more widespread adoption of the RBM methodology.

TransCelerate cites ensuring regulatory compliance as a critical part of the IQRMP. In aligning quality management plans across identified risks and defined Critical Data and Processes, cross-functional study teams are able to ensure appropriate plans are in place to effectively monitor, manage and mitigate key risks as outlined by the regulatory authorities.