Risk Based Monitoring (RBM) and Risk Based Quality Management (RBQM) are methods that have been encouraged by the EMA and the FDA since 2013. A risk based approach to quality management in clinical trials is now fully enshrined in ICH GCP E6 (Addendum R2, just approved).
These methods definitely require attention from operational teams. Their implementation, in order to be successful, necessitates a change management effort and budget which can better be anticipated, prepared and rolled-out at the level of Clinical Operations teams.
They allow to rationalise the operational conduct of clinical trials, and thus are often perceived as potentially reducing their operational costs. Therefore, a return on the initial investment is usually expected.
However, the main objective, according to TransCelerate, is as follows:
« By building quality and risk management approaches into the scientific design and operational conduct of clinical trials, risks can be mitigated and issues can be detected early and prevented entirely »
One of the most important questions that top managers in R&D / Drug Development may have in mind, when they are solicited to take a position regarding new ways of working within their organisations, is the following:
« Will the new method increase the probability of success of our development products? »
Poor protocol design, as well as data quality or integrity flaws are potential reasons for failure of a clinical trial. RBM enables the early detection and correction of critical quality issues, thus it may result in a positive impact on the probability of success of each phase of a clinical development plan. In addition, it increases the ability of operational teams to detect quality flaws while it is still time to correct them and to avoid their reoccurrence. With RBM, the clinical trial timelines are secured, if not shortened.
A retrospective review of reasons for delay or failure of clinical trials, or denial of regulatory approval for new drugs within the company, may allow to quantify this effect, and help project leaders and portfolio managers in factoring this into the probability of success communicated to their top management.
So, should we answer “YES” to the question?
To which extend is this legitimate to expect from RBM to enhance a product portfolio by an increased probability to meet the planned study timelines, as well as an increased probability of success of each development phase?
Isabelle Abousahl
President at alcoam by design SAS