5 common clinical trial project management mistakes
Getting a new clinical trial off the ground and moving smoothly takes careful project management. Even the best-laid plans can hit snags occasionally, but knowing what to watch for can help keep things organized. When planning for a project, it can be helpful to be aware of the most common mistakes and go into the project armed with advice on how to fix them.
Common clinical trial project management mistakes
Mistake #1: Unrealistic timelines
Getting a new trial off the ground as quickly as possible is often a high priority, but setting unrealistic timelines can set up the team for disappointment. When creating the timeline, factor in potential delays, such as a long IRB process or patient recruitment delays. It can be helpful to gather information about delays the team has experienced in the past and make suggestions for creating a more accurate schedule this time around. Don't be afraid to point out when requested timelines are unrealistic or if more resources are needed to complete certain tasks in a particular timeframe.
Mistake #2: Not having a backup plan for slow recruitment
With 80% of clinical trials delayed because of recruitment issues, it makes sense to plan for this as a possible outcome. Before recruitment starts, look at the patient database and consider a few factors that can cause common recruitment challenges. For example, DSP Clinical Research president Darlene Panzitta noted a few common mistakes sponsors make when choosing sites that can cause trouble once recruitment starts, including working with sites that are high prescribers of an existing version of the investigational treatment. This is because patients who are happy with their current medications may be less interested in joining a trial.
Mistake #3: You have too many stakeholders
In any project, plenty of people will want regular updates — even if they're not technically involved in the day-to-day details. This can take up a lot of time, so it can be helpful to add some structure and planning to the communications strategy. To start, having a single point person for each part of your project is ideal, and it can be helpful to outline your stakeholders using the RACI method. Determine who for each part of your project is responsible, accountable, consulted, and informed, and this person can be the main point of contact.
Mistake #4 Viewing project management as a “soft skill”
Project management is a complex skill that can require training, in addition to plenty of experience. If you haven't received training, ask about continuing education opportunities to build your skills. The Project Management Institute offers information on training and certifications, as well as on graduate programs in project management.
Mistake #5: Lack of resources for project managers
If the team at the site sees project management as a soft skill rather than one that involves training, it may be a struggle to receive the necessary resources. "I have seen clinical trial managers who have global trials with hundreds of thousands of patients, and because they have sister studies that are similar in nature, they have been assigned to manage those, too," said Hope Cullen Associate Director of Operations, Imperial CRS. "Just because similarities in different trials exist, they are still separate projects and should be managed as such." In the long run, hiring enough people to manage projects effectively can save a site money because the managers will have time to give their projects the attention they deserve. In addition to investing in education and staff, using project management software rather than spreadsheets is also helpful. Trello and Asana are two popular software options.
Looking for help with recruitment planning? Download our recruitment template for tips on creating an effective plan that accounts for potential roadblocks, too.
