5 project management tips for clinical trials
Many elements must work together for medical research to succeed, which is why project management for a clinical trial is complicated. Creating plans, communicating updates, calculating risk, and addressing delays are all crucial elements of a study's progress.
Even for individuals who don't carry the title of project manager, several people typically work together at a site to ensure the trial runs smoothly, including clinical research coordinators, site directors, and recruiting coordinators.
One important first step in effective project management at a site is assigning an official manager for each project. From there, the project manager can feel empowered to take on each step to help ensure the trial runs smoothly — especially when using these tips.
Project management tips for a clinical trial
1. Start with a project plan.
Before a new trial launches, starting with a clear plan can help proactively address delays and potential snags along the way. In addition to including a timeline of milestones, the plan should also outline staff members responsible for each element, communication details to be shared with the team, and a risk assessment that addresses potential roadblocks. Gantt charts and other project plan templates can help.
2. List potential risks and create a plan to address them.
The best case scenario is to entirely avoid patient recruitment delays, retention issues, or other problems throughout your trial, but a risk assessment plan can help address these issues in the chance they do arise. Challenges to consider include:
- Institutional Review Board (IRB) delays
- Staff turnover
- Recruitment delays
- Protocol changes
To address these issues, tracking the probability of each challenge, along with the projected impact and mitigation strategies, can help with adequate preparations.
3. Create a plan for stakeholder involvement.
Including crucial stakeholders for each part of the project can help ensure buy-in from the right people and keep everyone updated. In the RACI method of project management, each part of the plan will specify 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, the 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 person 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 project's progress, but don't need to provide approval.
4. Schedule time to think.
With so much communication and coordination, it's important to be diligent about scheduling time to analyze progress and ensure everything is on track.
"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 look for inefficiencies that crop up early on. Then, once the trial is over, review the experience before the next project begins. Is there anything that could be done differently? Solicit feedback from others on the team, and consider having a "post-mortem" meeting to open the floor to suggestions on improving 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.
