In its continued effort to modernize and streamline the way clinical trials are conducted and monitored, TransCelerate BioPharma has providing the first update to its position paper outlining a methodology for risk-based site monitoring (RBM) released in June 2013.

The update is a result of continued refinement of the position paper's concepts and assessing the experiences and lessons learned by the TransCelerate member companies that piloted the methodology.

"Through piloting TransCelerate's RBM methodology, framework and tools, we have sought to manage clinical trial risks through identification, categorization and appropriate mitigation," said Rehbar Tayyabkhan, executive director at Bristol-Myers Squibb and RBM project lead for TransCelerate. "We have learned important lessons from our member companies and regulatory agencies on tools like the RACT (Risk Assessment and Categorization Tool), which will help companies identify and plan their risk mitigation strategies, and a focus group has been tasked with assessing the feedback and implementing changes to the tool. We also have received valuable feedback on our pilot study monitoring plans."

Monitoring of clinical trials is required to ensure the safety and rights of participants, but the approach to monitoring can vary depending on multiple factors. A risk-based approach to monitoring allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study. RBM allows industry to become more effective and efficient in using resources and reducing costs. The goal of the TransCelerate RBM initiative is to establish a model approach to high-quality, risk-based site monitoring to enhance patient safety, ensure the quality of clinical data and create efficiencies.

The RBM position paper outlines the proposed methodology and tools. There are four steps in the process:

1)      cross-functional risk assessment of the program and protocol

2)      identification of critical data and processes, and the documentation of such, within an integrated quality risk management plan

3)     assessment of potential risk indicators, which, in alignment with critical data/processes, would direct the level of intervention when monitoring sites; and

4)     the monitoring execution of the study, which is not limited to just onsite activities, but includes other centralized and/or offsite approaches.

"We also recognize that there are many stakeholders in the clinical development landscape and, therefore, we have prepared training material for the benefit of all individuals and companies that may choose to implement the TransCelerate RBM methodology," said Tayyabkhan.

"This update, and especially the development and availability of training materials, is a significant achievement for the RBM team and TransCelerate overall," said Dalvir Gill, Ph.D., chief executive officer of TransCelerate. "These efforts demonstrate our commitment to our member companies, as well as the commitment to share progress and learnings for the common good of the biopharmaceutical industry at large."

TransCelerate is a nonprofit organization dedicated to accelerating and simplifying the R&D of innovative new therapies. Through collaboration across the global biopharmaceutical R&D community, it identifies, prioritizes, designs and facilitates implementation of solutions. Membership in TransCelerate is open to pharma and biotech companies with R&D operations. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Members that have joined since inception include Allergan, Astellas Pharma, Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Forest Research Institute, Medgenics, Shionogi and UCB.