All the above described components are essential for the achieving the RBM objectives. Still, by the implementation of the RBM strategy, we should be aware about some major RBM Pitfalls. Among them are:
Pitfall #1. SDV is reduced without any other action. A major risk, when under an RBM flag no other actions except the SDV reduction is taken.
Pitfall #2. Risk evaluation is not objective. This may happen if a human factor is involved in risk evaluation
Pitfall #3. Risk evaluation is biased. Bias is when an interested party is involved in the evaluation. In the economic science, this is called an “agency problem”.
Pitfall #4. Risk evaluation becomes outdated. The risk landscape changes during a trial.
Pitfall #5. Late data arrival. When the data, which is essential for such analysis arrives so late that no corrective action can help to mitigate the risk. Danger – patient safety.
Pitfall #6. Sites ignore RBM and do not improve. Today sites are hardly involved in the RBM initiative.
Pitfall #7. Monitoring team does not accept the new procedure. Why does this happen? Everybody has her/his own reasons; mostly it is scariness, lack of information and lack of involvement. Result – RBM stops working.
Electronic data management (eCTMS, eEDC, etc.) has developed for already more than 30 years and penetrating the clinical research more and more. It gets a new role in the risk management, introducing eRBM, where new system serves the purpose to guarantee early risk identification by providing a centralized location where risk data are saved, managed, monitored, and reported.