Clinical studies are expensive to mount—so given the high stakes, sponsors and contract research organizations (CROs) are under pressure to reach conclusions swiftly but without ever jeopardizing patient safety. One solution: Risk-based strategies that enable sponsors to zero in on issues in real time. Now, new governance underscores continuing regulatory support for—and perhaps even insistence on—this approach.
On January 28, 2022, the UK Medicines & Healthcare products Regulatory Agency (MHRA) published two new sets of guidance: Risk Adapted Approaches to Clinical Trials and Risk Assessments and Oversight and Monitoring of Investigational Medicinal Product Trials. These documents detail specific risk-adapted measures they recommend sponsors take in the conduct of clinical trials.
The guidance is clear:
It is recommended that a risk assessment is undertaken for all clinical trials. Identifying potential risks to trial participants and the reliability of the trial results on a trial basis and taking actions to mitigate those risks can only be beneficial for the quality of any clinical trial.
Specifically, the MHRA suggests that:
- Sponsors have documented risk strategies to ensure a consistent yet bespoke approach that examines the variable potential risks inherent in each trial
- Risk assessments be conducted as early as possible
- Risk assessments be documented and kept in the trial master file (TMF)
- Sponsors and site staff be aware of the risk assessments
- Risk assessments be continually reviewed against any new information or developments, such as a protocol amendment or new data—and both the review and any subsequent actions are documented
- Risk assessments are modulated depending on investigator site staff experience and training
These suggestions may feel like additional work to some sponsors, CROs, and sites. Yet they can make a dramatic difference in trial speed and results. Moreover, with the right technology, they can be easily implemented.
The right technology supports and simplifies ongoing clinical trial risk assessment.
Technology that gathers trial data and enables easy monitoring offers solutions to the MHRA’s suggestions. Such technology starts by collecting data from all functional areas across the study: clinical results, safety-related statistics, study-, site- and patient-specific data. Once aggregated, the system should visualize the data with the ability to cluster similar patients and sites if needed for advanced analysis. For example, investigators can compare a given patient to the study median and a similar cluster. Critically, the system should also identify outliers and pinpoint missing data. This can help investigators recognize risks they have previously identified and unanticipated risks through the risk assessment process, which is very difficult to do using manual processes. The Remarque Systems technology platform offers all these advantages.
Remarque Systems answers the guidance provided by MHRA
Remarque Systems sits on top of all the data collection methods a trial already employs agnostically and seamlessly integrates it into a single location. Sponsors can set triggers based on specific risk parameters—so in essence, risks announce themselves. Proprietary and patented machine learning then dynamically identifies additional areas that may warrant further investigation.
The MHRA recommends starting the risk assessment process as early as possible in the trial. By simply using the Remarque platform at the start of a program (as early as Phase 1), sponsors create a complete record spanning the entire trial. In addition, Remarque automatically documents all activity, so there is a transparent audit trail of events recorded and actions taken—and everything can be exported for uniform inclusion in the TMF.
The risk assessment process should be ongoing and continue throughout the life of the trial. The Remarque system allows authorized users to access all versions of the risk assessment for complete visibility of the process. In addition, Remarque notes each instance for version control.
Finally, Remarque allows for risk assessment at the site level. Not many technology providers have this ability, which can deliver a granular detail essential in uncovering underlying concerns.
Key takeaway: Adopting risk-based strategies is both wise and simple
With its promise to reduce clinical trial costs and timeframes while improving data quality and patient safety, risk-based quality management has become vitally important in the clinical trial industry. In parallel, regulatory bodies have been focusing their attention on risk-adapted approaches; the MHRA’s recent guidance joins the International Council for Harmonisation (ICH) and other regulatory groups.
In reality, most sponsors are likely already engaged in risk assessment; using technology to support this formalizes these activities and helps eliminate a lot of the manual activities associated with it. As a bonus, sponsors may subsequently enjoy reduced requirements for monitoring and risk-mitigation activity and documentation; for instance, Remarque’s built-in documentation proves that such analysis has occurred.
Following regulatory guidance is a must; in the case of the MHRA guidance on risk assessments, implementing the Remarque system will make compliance feasible and easy.