Efficient risk mitigation planning for a clinical trial

Each clinical trial faces numerous risks. Neglecting or reacting spontaneously at each materialized risk may delay trial completion, affect trial objectives and even derail the clinical trial. At the same time, pre-allocating excessive contingency resources to eliminate all potential risks, even with a low probability of occurrence and impact, may not be necessary. Therefore, optimal risk planning means finding the “right” balance between contingency resources, risk mitigation strategy, and risk tolerance. Most risk planning publications focus only on risk identification and risk assessment. Risk mitigation strategy planning is often overlooked. A contingency budget is routinely assigned as a percentage of a clinical trial budget, e.g., 10-20%, and is not aligned with the clinical trial risk level. Therefore, to derive an effective clinical trial risk mitigation strategy, a new methodology based on mathematical modeling was developed and validated for a Ph2 clinical trial.