(originally presented by Artem Andrianov on German EPharma Day)
The new EU Clinical Trials Regulation (CTR) becomes applicable already on 28th of May 2016. It introduces a number of major changes in the clinical trial’s application, operations, documentation, and assessment. It is very important to get prepared to this change already now in order to avoid difficulties with the future trial approvals in EU.
Although CTR is not taking the direct reference on RbM, it refers to principles of Good Clinical Practice (GCP) and Quality by Design (QbD). These principles are the underlying in RbM as well. Therefore, the author offers to apply RbM as a practical mechanism and process in order to embrace the new EU regulation.
The regulation underlines the interest of subjects and assigns to them an ultimate priority over all other interests.
What tools are available in order to help us in the implementation of the new regulations? The RbM approach offers large flexibility and control for these purposes.
The identification of risks, which appear if the regulation is not correctly implemented, helps to avoid them. How to achieve that? Apply several key risk indicators (KRIs) within the digital infrastructure, which can help to monitor automatically the clinical trial and free your time for the real research.
RbM can be defined rather “narrow” following the FDA’s definition:
- Remote monitoring (application of technologies to access the data remotely, saving the costs of on-site visits.)
- Reduced monitoring (targeted Source Data Verification) or
- Triggered monitoring (monitoring based upon pre-defined triggers, i.e., when risk was already identified)
or “broader”, following the EMA’s definition:
RbM is “preventive clinical trial management approach, which aims to identify, assess, control, communicate and review the risks associated with the clinical trial during its lifecycle in order to guarantee the protection of trial subjects’ rights, well-being, integrity and safety and the assurance of quality of data and the trial credibility.”