By Venu Mallarapu | Published: March 20, 2012
It is a universal fact that the escalating costs of discovering new medicinal products are driving sponsors and CROs to scrutinize every dollar spent in the process. The situation is escalating fast as pressure mounts with the blockbusters of yester years come off patents. This means that there is a need for all the stakeholders in the value chain to revisit their approach to existing processes and come up with innovative ways to save costs
Key trends
Risk based site monitoring
US FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist 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”. As per the document its overarching goal is to “enhance human subject protection and the quality of clinical trial data”. However, it clarifies on the strict interpretation that the industry has assumed long back and has spent billions in monitoring the sites. While this is draft guidance it is more than likely that this will end up in establishing the guiding principles for central monitoring of clinical trials, as such is the intent.
Risk based source document verification
Primary activity of site monitoring is the source document verification and as was the case in site monitoring, industry has been mostly using the strict interpretation of source document verification. This resulted in 100% of source documents (patient eCRFs) being verified by the site monitors. However, the industry has realized that “law of diminishing returns” applies to this process as well and has been reducing the percentage of documents verified by the monitors. Medidata’s Insights “Targeted Site Monitoring Trend Snapshot” published in Applied Clinical Trials website confirms this trend. According to this report the SDV percentage has reduced from 85% in 2007 to 67% in 2010.
Virtual clinical trials
Another key trend that is slowly evolving in this context is complete virtualization of clinical trials. Pfizer is taking the lead in this space. While Pfizer’s REMOTE program is ongoing, an interim feedback from the program is provided by Mr. Craig Lipset, Head of Clinical Innovation at Pfizer is provided by Applied Clinical Trials in their article titled “Pfizer’s REMOTE Virtual Experience”. As highlighted in the article, they are going through the roadblocks of an early adopter.
