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 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 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 by using the software. It is centralized due to databases, the trial act’s as a single point of reference for any action. 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.
There is a growing consensus that risk-based approaches to monitoring, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality. 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.
KRI Needs To Be Factored
In the context of clinical research, KRIs needs to be factored in when a monitoring plan for a clinical trial is prepared. The USFDA 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. As trials become larger, more complex, the use of EDC and other technology tools make centralized monitoring more effective in ensuring the quality and integrity of data. The USFDA’s involvement in centralized monitoring remains consistent in recognizing some amount of on-site monitoring will remain critically important in most cases. A number of pharmaceutical companies and CROs are starting in-house development of RBM applications.
An informal survey conducted with a number of JReview customers on their plans and thoughts of RBM – many of whom are also TransCelerate members. A number of JReview customers thought that Risk Indicators should be a mixture of clinical study data based indicators which could be about 75% and operational metrics based indicators which could be about 25%.
The 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 in 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.
Indeed, the centralized monitoring teams are formed by the out of the box analytics report of RBM that can define key risk categories, risk indicators, weighting factors from all clinical and operational source data available, set thresholds, and specify suggested actions. It also performs visualization of risk evolution by site/country/region based on multiple risk indicators and categories. Factors such as, risk indicator result visualization by site, country, or region, subset by attributes, interactively sorts any column for site ranking is defined as some of the risk indicator definitions.