3 March 2025
Clinical study management: identifying risks and avoiding problems
Conducting clinical studies is complex. Successful study management depends on many factors, and unexpected problems can jeopardise an entire research project. However, most risks can be anticipated and addressed early on. The concept of risk-based study management is based on this idea.
Two study teams from research groups at the Department of Clinical Research (DKF) have already gained experience with this approach. Together with a contact person from the DKF Scientific Services, who is well acquainted with the respective project, they regularly assess their study for potential weaknesses and avoidable pitfalls. This proactive approach has already led to precautionary measures that help prevent situations that could cause delays, unnecessary additional effort, and increased costs – or even compromise participant safety.
Closing planning gaps
In the case of the OxyTUTION study, for example, it became apparent that a committee to assess safety aspects, a Data Safety Monitoring Board, still needed to be established, and its procedures had to be defined. Additionally, some import permits for the study medication were still pending. These and a few other planning activities were identified as potential risks to the smooth progress of the study. Addressing them at an early stage allowed the study team to enter the international phase of the study well-prepared and without delays, ensuring that all energy and resources could be dedicated to the recruitment of participants and the support of the additional study centres.
«Risk-based study management makes it easier to control complex processes and supports the early identification of potential issues. This is particularly helpful for multicentre studies.»
Dr. Svenja Leibnitz, Assistant Physician Endocrinology, Diabetology & Metabolism, University Hospital Basel, DKF Research Group Mirjam Christ-Crain
In the EMINENT study, risk based study management revealed that oversight of protocol deviations and the escalation strategy in case of deviations could be further improved. The delegations within the sponsor team also needed more detailed specification. Identifying these issues early and addressing them in the study’s Europe-wide planning phase was crucial to avoiding delays or additional costs later on.
«Thanks to the risk-based study management, we were able to uncover and rectify specific weaknesses in our multicentre study.»
Stephanie Andersson-Riva, Project Manager Neurosurgery, University Hospital Basel, DKF Research Group Raphael Guzman
Risk catalogue enables quick assessment
Using the catalogue of questions compiled by the DKF Scientific Services, study teams can systematically review their clinical study for potential weaknesses and define corrective measures. A designated contact person from DKF Scientific Services accompanies this process by assisting with the definition and implementation of appropriate measures, ensuring proper documentation throughout the entire life cycle of the study.
Risk-based study management is particularly valuable for large, multicentre and international clinical studies, as it helps maintain oversight of the many complex tasks involved. However, smaller projects can also benefit from this approach. «Analysing risks for an entire study requires some effort, but being well-prepared ultimately saves a lot of time», concludes Julia Manzetti, Senior Monitor at DKF Scientific Services.
"Initially, I had no great expectations of the extended, risk-based study management, especially as we had already carried out regular risk management for monitoring. However, a critical external assessment revealed gaps in our planning, which we were able to correct accordingly."
Dr. Tim Hallenberger, Assistant Physician Neurosurgery, University Hospital Basel, DKF Research Group Raphael Guzman
What is risk-based study management?
The idea
Circumstances that can delay a clinical study, make it more expensive, or force it to be discontinued are often avoidable if appropriate measures are taken early on.
The procedure
Using a structured risk catalogue, potential issues that could jeopardize the study are systematically identified. Solutions are developed and implemented, and risk analysis and corrective actions are continuously reassessed throughout the study’s duration.
The benefits
Risks to which a particular study is susceptible are identified before they arise. They can either be entirely avoided or mitigated in such a way that they do not jeopardise the study. Potential inspection findings can also be prevented.
The service
A designated contact person from DKF Scientific Services advises the study team and supports the process of risk analysis and mitigation.