5 Project Management Tips for Clinical Trials

Project management for a clinical trial is a complicated task. From creating a plan, to communicating updates, to calculating risk, there's always something to do, and it can be challenging to stay on top of it all.

Even if project manager isn't your title, there are typically several people at a site who work together to ensure the trial runs smoothly. These roles can include clinical research coordinators, site directors, and recruiting coordinators.

One important first step of effective project management at a site is to assign an official manager for each project. From there, a project manager can feel empowered to take on each step to help make sure the trial runs smoothly.

Once you've been assigned project manager, follow these tips to get – and stay – organized for the duration of the trial:

1. Start with a project plan.

Creating a plan before a new trial launches is one of the best ways to avoid delays once the trial starts. In addition to including a timeline of milestones, your plan should also outline staff members responsible for each part of your plan, communication details to be shared with the team, and a risk assessment that addresses potential roadblocks (more on these pieces later). Gantt charts and other project plan templates can help.

2. List out potential risks and create a plan to address them.

Of course, your goal will be to avoid any patient recruitment delays, retention issues, or other problems throughout your trial. Just in case, consider creating a risk assessment plan along with your larger project plan. Challenges to consider include:

  • Institutional Review Board (IRB) delays
  • Staff turnover
  • Recruitment delays
  • Protocol changes

If that list by itself is raising your blood pressure, then tracking the probability of each challenge, along with the projected impact and mitigation strategies, can help you feel more prepared.

3. Create a plan for stakeholder involvement.

Including key stakeholders for each part of your project can help ensure you're getting buy-in from the right people and keeping everyone updated. In the RACI method of project management, for each part of your plan, you'll make note of who needs to be involved, and in what way. The categories of RACI include keeping track of who's:

  • Responsible: The person who does the actual work of the task – ideally one point person. For example, you may have one marketing lead who gathers outreach material to submit to your IRB.
  • Accountable: Generally the person managing the one responsible for the task. This person ensures the work is done thoroughly, accurately, and on time.
  • Consulted: Additional people who weigh in on the piece of the project, generally supporting team members, subject matter experts, etc.
  • Informed: People who are kept up-to-date on the progress of the project, but don't need to give approval.

4. Schedule time to think.

With so much communicating and coordinating going on, it can be hard to find time in your schedule to actually analyze your work so far and make sure everything is on track. Project management experts recommend blocking off specific time on your calendar to think. Call it what you will in the events you create, particularly if your team has access to your calendar, but protect your time as much as you can.

"Use your ‘thinking time’ to keep a handle on the things you know are necessary for project success: establishing project scope, refining objectives, defining the course of action required to attain the objectives, and otherwise planning, organizing, prioritizing, and establishing metrics," Dalfoni Banerjee, principal consultant and CEO, 3Sixty Pharma Solutions LLC, wrote in Clinical Leader.

5. Monitor and analyze your results.

Throughout the project, monitor results and be on the lookout for inefficiencies that crop up early on.

Once the trial is over, take time to review the experience before you move on to your next project. Is there anything you would do differently? Solicit feedback from others on your team, too. Consider having a "post-mortem" meeting and open the floor to suggestions on how to improve the process for your next project.

Looking for help on the patient recruitment piece of your project plan? Download our clinical trial recruitment template to get organized and start your plan on the right foot.