Clinical trials are part of a long and careful research process that delves into testing which medical approaches and new pharmaceutical products work best for different groups of people affected by particular medical conditions. Since their purpose is to perform research and live human beings are involved in the research as participants, the trials need to follow stringent scientific standards. They also need to be monitored so as to ensure the safety of the human participants.
Traditional monitoring involves patient visits by the clinical investigators and research associates, and source data verification about the new pharmaceutical products or medical treatments. Such monitoring is highly error-prone, expensive, time-consuming, and does not provide real-time error detection. Risk-based monitoring (RBM) is a method of monitoring that uses software. It is centralized due to databases about the trial acting as a single point of reference for any actions. Monitoring is continuous and real-time detection of the error is possible. There are certain thresholds or risk indicators assigned prior to the start of a trial. The RBM software is able to detect potential adverse events by monitoring the threshold level or risk indicator level reached by a certain process in the trial. The RBM method also reduces costs due to its targeted approach to dealing with any events thus ensuring less resource wastage.
The US Food and Drugs Administration (FDA) outline’s three steps in a risk-based approach to monitoring:
- Identification of critical data and processes that are important for that particular trial/study
- Performing an assessment of all potential risks in the clinical trial/study
- Development of a monitoring plan that outlines the responsibilities to be taken up everyone in the trial/study
The second step in this outline is where the key risk indicators for a clinical trial/study are identified and listed out. A key risk indicator (KRI) is defined as a measure that gives an indication of how risky an activity or process or procedure might be. In the context of clinical research, KRIs need to be factored in when a monitoring plan for a clinical trial is prepared. The FDA recommends that all KRIs need not be necessarily included in a clinical monitoring plan. Only those that are necessary for a trial need to be included since every clinical trial focuses on different objectives or aims. These necessary KRIs are chosen during the risk assessment phase of a clinical trial or study.
Some KRIs that is considered important to have in a clinical trial or study are described below:
- Safety - This KRI relates to the potential adverse event scenarios that can occur in a trial. It also includes the concerns regarding the manner in which safety information is processed during a trial.
- Investigational product - This KRI is to do with the new drug or treatment that is being tested in the trial. It handles questions arising from accountability, drug dosage, and compliance with drug administering protocols.
- Recruitment/Discontinuation - Patients need to be monitored for safety and efficacy purposes. Also, the levels of enrollment for participating in a trial needs to be monitored for effective resource utilization.
- Issue management - This KRI deals with the issues that crop up in a trial. It can be the number of or type of deviations from the study protocol. It can also be about general issues such as severity of unresolved issues.
- Data quality - This KRI tackles the issues arising out of the detection of abnormal trends in the data gathered during a clinical trial. Case Report Form (CRF) completion level is also monitored as a data quality KRI.
- Staffing, facilities, and supplies - This KRI involves monitoring staff training needs, whether the delegation of responsibilities has been optimal or not, whether proper maintenance, storage, and calibration of supplies and equipment has been maintained or not.