I am utilizing the term “remote monitoring” to mean a remote evaluation of the clinical data carried out by sponsor personnel or a representative at a location other than the investigative site.
The monitoring techniques that I followed and understood for several years, was that a monitoring visit was conducted at the investigative sites every 4-8 weeks depending on site enrollment and 100% source Data Verification (SDV) was conducted to insure subject protection and the overall quality of clinical study. However, as many of you are aware, this approach was resource and cost intensive. Also, this approach did not necessarily ensure the quality of the clinical trial data. It has been several years since the FDA issued a guidance regarding Risk Based Monitoring (RBM) and in my opinion many sponsors/representatives have focused on the risk and not so much on developing innovative approaches to improving the effectiveness of monitoring. For example, developing a monitoring plan that includes remote monitoring – Risk Base Monitoring and being aware of the electronic technologies available is an effective use of time and energy rather than focusing on reasons why remote monitoring – Risk Base Monitoring will not work.
A point to consider; it has been determined that the majority of findings identified during on-site monitoring visits can be identified during a remote monitoring visit as well. Remote monitoring continues to allow sponsors to meet their regulatory obligations, while continuing to enable clinical trials to be safe but enabling them to be quicker and economically executed. I certainly understand that the small Biotech is nervous about moving away from On-site monitoring and 100% Source Data Verification due to the fact that they want to ensure that they are providing quality clinical data to the FDA. In my opinion, some small biotech company feels that the only way they can stand behind the quality of the clinical data and thus, the clinical trial is to conduct On-Site monitoring visits where they can review all aspects of the clinical trial. Perhaps, a monitoring plan that allows for both On-Site and remote monitoring – Risk Base Monitoring at different times points during the clinical trial is a more comfortable approach to take.
The “FDA suggests that regular on-site monitoring every four to eight weeks with 100% Source Data Verification (SDV) is no longer called for in modern research, particularly due to the technological advances that make it possible to monitor data quality more efficiently. The agency proposes that the use of a centralized, risk-based approach (remote monitoring) can reduce the cost of site monitoring, with the ultimate goal of enhancing the protection of human subjects” The clinical trial staff at the investigative sites also needs to be tech savvy but not tech experts, internal site quality process needs to be updated accordingly and the investigative staff will need to be flexible, understanding the sponsor will be utilizing new techniques and processes instead of the old way of monitoring clinical trial data.
Amazingly, some sponsors and sponsor representatives are still embracing the On-Site monitoring process and focusing on what could go wrong rather than the positives and understanding the intent of the FDA Guidance. I am hopeful that we will all take that critical step forward and embrace the change that is on our door step.