By: Chantal Sfeila, PharmD | November 10, 2016
How to manage and mitigate risk in global clinical trials.
Managing risk is a critical part of any project, but in clinical research it takes on added importance. The majority of clinical research is conducted globally and clinical studies can have sites across multiple geographies. The sites are selected on the basis that they have the required patients, infrastructure and expertise. Thus, as we manage the project we need to also understand and mitigate for any prevailing geopolitical, social or environmental issues which may affect them, their patients and ultimately the integrity of the research.
At QuintilesIMS, we believe the best way to address these risks is by developing a custom risk management plan for every research initiative, that is agreed upon by all stakeholders, and updated continually throughout the project.
When we work with our clients on a project, one of the first conversations we have is around the risk management process, and how we will identify, manage and mitigate risks. It is important that our clients understand the risk management strategy and what will happen if and when certain actions may occur. This helps create a risk management culture for the project, and ensures that we can work together to mitigate any issues as they arise.
We then bring all of the project stakeholders to the table, including the sponsor, the functional leads, and the central lab, among others, to identify any possible risks and how they could affect the project. It is important to have many voices and areas of expertise represented in these conversations to be sure all possible risks are considered, including technical, epidemiological, social, political and economic issues that are relevant to each trial and site. The resulting list of risks will range from minor issues, such as technology malfunctions, to major crises, including earthquakes or terrorist attacks.
For global trials, we prepare a multi-tiered risk management plan that identifies risks for each site (or at least major sites) and geography, then merge them into a global risk registry that takes into account how a risk in one region or site could impact the entire trial.
Having these collaborative conversations helps us shape a robust risk management registry that can evolve over time based on where we are in the clinical research program, and what risks are more or less prevalent based on current conditions.
Once the risk management plan is defined, we integrate it into the broader project management plan to align risks with key milestones, and define monitoring and mitigation strategies for each risk category. In the case of an infectious disease trial, for example, we might implement remote monitoring tools and mobile data collection to minimize risk while supporting data verification from off-site locations.
Mitigation plans are also established for high-impact external risks, such as the local team contracting an infectious illness, or political unrest. In these cases, staff will have pre-defined response plans that are designed to ensure the safety of staff, patients and clinical data.
Defining mitigation strategies is a key component of any effective risk management program, though it is only one aspect of the plan. We also implement monitoring tools that monitor for risks in real time, and send alerts when issues arise. For example, if recruiters don’t reach target goals by a pre-determined date, if patients miss appointments or specific tests or if a lab fails to secure samples according to the protocol, alerts can be sent triggering pre-defined response plans, which might include additional education, mentoring.
Training the local team on how to identify and deal with risks and giving them the tools and strategies to respond, reduces the chance that people will panic in the face of a crisis, and helps to minimize the possibility that small issues aren’t allowed to grow into major problems.
When trials end, we take what we’ve learned and apply it to future projects, to help us better identify issues that may or may not have an impact on the next project. Having a formal lessons learned process that can be shared across trial sites helps us maintain a culture that values risk management. It also helps us identify opportunities to improve our strategies, through better training, new technology and innovative thinking about what could affect the outcome of these trials.
Our approach to risk management is a differentiator that helped make QuintilesIMS a leader. Our commitment to managing and mitigating risks gives our clients the confidence they need to know that we will do whatever is needed to best manage the risks related to clinical research.