As a Master’s of Public Health student at Emory University, one of the most intriguing ideas I encountered was that of upstream prevention. This concept is often illustrated by a metaphor involving drowning bodies in a river; a panic ensues at the riverfront as rescuers eagerly jump in to save the drowning victims. Although many people are saved, the rescue team can’t keep up with the sheer number of victims. One member of the rescue team (the public health expert) decides to travel upstream to find the cause of the problem. Although this member of the team is harshly criticized for abandoning the immediate rescue effort, he is later praised for identifying the source of the problem and preventing many deaths.
Too often in clinical monitoring, we become so wrapped up in immediate rescue operations (e.g., query resolution and/or protocol deviation reporting) that we lose sight of upstream prevention issues (e.g. taking steps to increase site preparedness in order to avoid queries and protocol deviations before they happen). This is not to say that all site issues can be prevented by increased training and awareness, but a shift in emphasis can reduce the burden of these issues on sites and sponsors. As representatives of the sponsor, it is critical for monitors to take the lead not only in resolving site issues, but educating sites on how to prevent them.
There is a need to promote a dynamic model of clinical monitoring that focuses on both downstream resolution and upstream prevention. The dynamic nature of the approach will allow it to be compatible with sites of varying levels of experience and skill. Less experienced sites may require considerable assistance with both immediate issue resolution and future-oriented site preparedness. Sites with more experience may require less assistance with immediate resolution or future prevention, while most sites will fall somewhere in between. It is the responsibility of the monitor, along with the study team, to determine the needs of each site and dictate their approach accordingly. In addition, the approach of the monitor should be grounded firmly in the appropriate regulations.
IMARC’s FAIR Shake has the potential to inform this model as it directs monitors to base decisions and actions on the requirements of the sponsors and investigators (21 CFR 312.50/21 CFR 812.46 and 21 CFR 312.60/21 CFR 812.100), which are summarized as FAIR: Federal Regulations, Agreements (Investigator-IDE, 1572-IND), Investigational Plans, and Requirements of the IRB. FAIR Shake should be used as the foundation for monitoring activities operating both within the realms of immediate site issue resolution and future prevention.
There are multiple benefits to utilizing this type of dynamic approach to clinical monitoring. This model has the potential to reduce costs and improve trial efficiency, therefore allowing devices and drugs to be moved to the market more quickly. In addition, the increased emphasis on upstream prevention will allow sites to be more adequately prepared for both monitoring visits and regulatory audits. Furthermore, site operations and processes can be streamlined and made more precise in order to improve human subject protection and data integrity, two of the principle goals of clinical monitoring. Lastly, this approach coincides with the FDA guidance on risk-based monitoring. Both the dynamic, upstream model and the risk-based monitoring guidance utilize multiple strategies to target critical study parameters in order to improve trials for sites, sponsors, and patients. As the complexity and number of studies continues to grow, new approaches will be necessary to ensure adequate oversight of clinical trials.
When planning for your research studies, do you consider upstream prevention? Please share your experiences with us.
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