5 Common Clinical Trial Project Management Mistakes

Getting a new clinical trial off the ground and keeping it moving smoothly takes careful project management. Even the best-laid plans can hit snags from time to time, and knowing what to watch for – and when to ask for help – can help get your project back on track.

As you create your project plan, be aware of the most common mistakes and go into your project armed with advice on how to fix them.

Mistake #1: Unrealistic timelines

Of course, everyone wants to get a new trial off the ground as quickly as possible. But setting unrealistic timelines only sets up your team for disappointment. When creating your timeline, factor in potential delays that are outside your control, such as a long IRB process or patient recruitment delays. If you're new at the site, gather what information you can about delays the team has experienced in the past, and suggestions for creating a more accurate schedule this time around. Don't be afraid to point out when requested timelines are unrealistic, either, or if you'll need more resources 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, there is a good chance yours will be too, so it makes sense to plan for the almost inevitable. For example, you may plan to enlist the help of a patient recruitment company if you don't have enough patients in your site's database.

Before recruitment starts, take a look at your database of patients 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 most notably working with sites that are high prescribers of an existing version of the investigational treatment. This is because patients who are happy on their current medications may be less interested in joining a trial. You and your team know your site best, so if you believe based on the study protocol or other factors that you'll have difficulty recruiting for a particular trial or may experience delays, plan accordingly.

Mistake #3: You have too many stakeholders

In any project, there will be plenty of people who will want regular updates — even if they're not technically involved in the day-to-day details. If you find that most of your day is taken up with email, consider a few different strategies for organizing your communiques. To start, it's ideal to have a single person with whom you liason for each part of your project. 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. The person responsible should be your 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 trainings and certifications, as well as information on graduate programs in project management.

Mistake #5: Lack of resources for project managers

If the team at your site sees project management as a soft skill, rather than one that involves training, you may also struggle to receive the resources you need for success. "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, in an ebook on clinical trial project management. "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, it’s also helpful to use project management software, rather than spreadsheets. 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.