The number and complexity of clinical trials have created new challenges to clinical trial oversight like variability in clinical investigator experience, site infrastructure, treatment choices, standards of healthcare and challenges related to geographic dispersion. Based on this subject, a workshop was conducted by Quintiles, world’s largest provider of bio-pharmaceutical development and commercial outsourcing services on Risk Based Monitoring (Data-Driven Trial Execution) and its role in shaping the future of clinical research in Mumbai recently.

Risk Based Monitoring is a robust platform that integrates multiple data sources, including labs, Clinical Trial Monitoring System (CTMS), resource management third party data and Electronic Data Capture (EDC), all in one place.
 
Talking on the relevance of Risk Based Monitoring for clinical data quality, Jagadeesh R, senior director, Global Data and Safety Monitoring (GDSM), Quintiles India says, "The traditional methodology of conducting frequent on-site visits, with 100 per cent source data verification (SDV), still dominates the clinical development landscape. A risk based approach characterized by a clearly documented upfront assessment coupled with centralized monitoring and data review, has emerged as the future of clinical development. This approach has been supported by USFDA, European Medicines Agency (EMA) and others as a new way to help mitigate potential study risks and bring efficiency and enhanced quality to clinical trial execution."

"A growing pressure leave bio-pharmaceutical companies with few options but to choose this new approach," he adds.

The pharma industry faces daunting challenges like increasing development costs and heightened levels of trial complexity and regulatory scrutiny. These challenges, combined with current market realities of decreasing reimbursements, dwindling pipelines and reduced chances of bringing a product to market, are driving the imperative for change.

Talking about the advantages of Risk Based Monitoring (RBM), Anita Limaye, director, clinical GDN, Quintiles India says, "RBM can directly impact many of these challenges by facilitating more efficient trial delivery without undermining data quality or patient safety. In essence, RBM involves identifying study specific risks, implementing a process to mitigate and monitor those risks and continually reviewing those risks throughout the study life cycle. By targeting key data points and sites that require a high degree of scrutiny, you can direct on-site and remote resources to areas where risk is highest. The optimized balance of monitoring resources leads to greater efficiency, while centralised data surveillance using advanced technology permits enhanced scrutiny of trial data.  

Quintiles has executed more than 80 studies using risk based monitoring principles and processes with over 20, 000 sites and 2 lakh patients.

Effective monitoring of clinical investigations by sponsors is critical to the protection of human subjects and the conduct of high quality studies. FDA regulations require sponsors to monitor the conduct and progress of their clinical investigations. The regulations are not specific about how sponsors are to conduct such monitoring and are therefore compatible with a range of approaches to monitoring that vary depending on multiple factors.

Sponsors of clinical investigations involving 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 clinical data submitted to the FDA.

Concludes Ajay Solanki, associate director, clinical operations, Quintiles India by stating, "Quintiles data driven trial execution can save up to 25 per cent in cost reductions, risk based monitoring is not about taking risks to save money. Rather, It's is about de-risking trial execution by harnessing near real-time data to drive actionable insights and better decision making.  
 
In 2013, the US FDA released its guidance for clinical trial oversight that reflect a modern, risk-based approach focused on critical study parameters and relying on a combination of monitoring activities to oversee a study effectively. Known as Risk-Based Monitoring or RBM, the approach is changing the way clinical trials are being done globally.