The time and cost to deliver successful clinical trials has increased over time, making it harder to deliver innovative new drugs to patients. One of the reasons for these increasing budgets and timelines is risk throughout the trial process. From finding patients, to staffing sites, to predicting how a drug will work, these projects contain uncertainty, at times forcing stakeholders to make best guesses knowing full well they will have to adapt their assumptions as they plough ahead.
Although you can never eliminate uncertainty from any scientific endeavor, you can mitigate many of the risks that are common in clinical research through effective project management.
Formal project management methodologies are used across industries to streamline delivery of major business initiatives, from building skyscrapers to implementing massive software solutions. Yet the biopharma industry has been slow to recognize the value that formal project management brings to the clinical research lifecycle. A good project management practice can help clinical researchers deliver more efficient and productive trials with less downtime and fewer errors, while delivering higher quality research delivery. It also creates a more collaborative, trusting environment where stakeholders work together to problem-solve. That all translates to time and money saved.
Do your due diligence
The key to good project management is making time at the beginning of the project to plan. The output of the planning process is an integrated project management plan, a governing document that describes how the project will be executed, monitored, and controlled. Key components include establishing baseline, a schedule of key milestones, clearly defined roles and responsibilities, and a risk registry that identifies and weighs potential risks at every stage of the project — and includes mitigation plans to overcome them. By doing this work up front, project teams can successfully avoid or lessen the impact of problems that often plague these trials.
For example, recruiting patients is one of the most complicated and costly aspects of clinical research, absorbing up to a third of the entire trial timeline and budget. When project teams spend the time upfront defining the risks associated with their recruiting goals they can implement plans to better manage and minimize their impact to schedules and budgets.
The objectives of project risk management are to increase the likelihood and impact of positive events (opportunities), and decrease the likelihood and impact of negative events (risks). Early, robust, comprehensive and iterative risk management underpins the successful delivery of projects. Positive events improve ability to create value, enhance performance and deliver greater benefits to key project stakeholders. Consideration of such events should be an important part of both the project’s strategic planning and the risk identification process. Activating triggers for such opportunities should be a focus during regular risk log reviews. In this example, having back-up plans in place ahead of time means clinical teams can immediately implement supporting strategies when necessary which minimizes wasted downtime.
A good project management plan will also include a robust performance measurement baseline, an integrated, quantitative baseline against which project success is measured, and change control enforced. It enables clear expectations for communication between all key stakeholders, including site staff, research leaders, CROs and sponsors. Having a common understanding of project goals and having a communication plan ensures everyone involved with the trial is up to date on its progress and creates channels to discuss concerns or questions. This enables a culture of transparency and problem-solving that prevents small issues from turning into costly mistakes.
Good project management may not solve every problem a trial faces, but it can eliminate a lot of the chaos, confusion and downtime that can occur when these issues arise.