Completing any multi-part task requires organization, coordination, and discipline. Running a clinical trial is, of course, no different. From creating a plan, to communicating updates, to calculating risk, there are always many moving pieces, and solid project management is required to ensure the trial runs smoothly.
The Project Management Institute (PMI) defines project management as the "application of knowledge, skills, tools, and techniques to project activities to meet the project requirements." It involves expertise in scope, time, cost, quality, risk management, communications, and stakeholder management, among other areas.
To further understand the concept of project management, it can be broken into five basic phases:
Applied to clinical trials, project management is critical to ensure that trials are set up, enrolled, conducted, and reported on-time and on-budget. Here, we’ll discuss the role of the clinical trial project manager, as well as tips for project plans, stakeholder involvement, communication, IRB submission, and evaluation.
The responsibilities of a clinical trial project manager differ from site to site, but in general, they include these elements, each of which are critical to the success of the trial:
Vendor selection: it takes more than just the study team to conduct a clinical trial. Often, outside vendors are brought in to offer expertise in things like clinical trial technology, such asIWRS and electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment. It may be the project manager's job to vet these vendors and assist with comparing options.
Timeline and budget oversight: All trials begin with a specific timeline and budget, but nearly 80% of clinical trials are delayed, and many also end up over budget. Research is slowed and patients are left waiting for answers. This is where a project manager can leverage expertise to keep the trial team accountable in terms of both time and money spent on the trial, as well as manage expectations in case of shifts in either the timeline or the budget. This requires regular communication with key stakeholders, and a knack for keeping people on task.
IRB submissions: All trial materials, including outreach materials, must be reviewed and submitted for Institutional Review Board (IRB) approval. Gathering materials from stakeholders and vendors and submitting them appropriately is a key task that may fall to the clinical trial project manager. Every IRB is different, so the project manager will need to look at previous submissions and any submission templates that are available to ensure the study's particular IRB requirements are met.
Report creation: As part of tracking the progress of a trial and staying on top of timeline and budget, clinical trial project managers may also be charged with generating and distributing reports on various aspects of study progress. The content and frequency of these reports should be determined through discussions with key stakeholders at the outset of the trial. Project managers may take advantage of available technology to automate reports on, for example, patient enrollment or reasons for ineligibility, which will allow them to devote more time to data analysis.
Meeting planning: From time to time, the trial’s key stakeholders will need to meet to discuss progress and roadblocks the trial is facing. The project manager will likely be charged with planning and leading these meetings to ensure that all details are covered. If the project manager works at a site, these meetings may also include the trial sponsor who will be eager for updates and feedback.
As you can see, the role of the project manager is not a small one. But despite a wide and varied role, there are ways to streamline processes and responsibilities to ensure the work gets done. Next, we’ll share some tips and tricks for project management success.
Creating a detailed project plan is one of the best ways to prevent delays and issues once your trial launches. Your plan should include a timeline of milestones, with dependencies for each section. You can also include key stakeholders for each section.
There are several online tools available to help you manage your project and stay on schedule. Trello and Asana are two of the most popular project management software options out there. Content marketing consultant Jessica Stansberry outlined what she likes about both options in a helpful YouTube video – she includes a quiz to help you make the decision, too:
Both tools allow you organize your project into tasks and assign sections to different team members. Stansberry mentions that Trello might be the better option for those who like to use sticky notes and other visual organizational tools, while those who stay organized with lists and spreadsheets tend to prefer Asana.
The project management team at Antidote uses Asana. Vanessa Lopez, account manager at Antidote, said that putting the whole project in Asana before launch helps her team stick to a timeline.
"We put in all of the main tasks that need to be completed throughout the study – target dates, descriptions, who they're assigned to, and do weekly progress and project updates," she said. "That way the team is aware of what's going on in each of the projects."
Software Advice compiled a list of additional project management software, along with articles comparing similar tools to help you make your decision.
In addition to outlining who and what is involved in each piece of your project, it's also helpful to take stock of the potential risks inherent in your plan. Any project has different levels of risk. Making a plan for what you'll do if something goes wrong can help assuage anxiety – and if anything does go wrong, you'll thank yourself for preparing for it.
For each risk on your list, take your best guess at the probability of it happening, and the impact it would have on your project. A few examples to start with include:
If you've run projects at your site or other sites in the past, you can base your risk assessment on past experiences. Before your project starts, set up time with other members of your team to outline potential risks, how you've coped with them in the past, and strategies to mitigate their impact – or, if possible, prevent them altogether.
Before your trial can launch, first your protocol and materials must be approved by your Institutional Review Board (IRB).
If you have access to a packet of materials that was approved in the past, taking a close look at it is one of the best ways to help guide your new submission. Because not every IRB is the same, your experience with other IRBs may not be as helpful here, though of course it's beneficial to have gone through the process before.
When working with an IRB new to you, talk with the IRB administrator before submitting your materials, advises Raffaella Hart, Director of the Biomedical Research Alliance of New York (BRANY) IRB.
IRB administrators can answer any questions you have about their submission process, and help you fill in gaps or make corrections to ensure a smooth and efficient process.
Hart also recommends triple checking your submission before sending it along to the IRB. Every time you have to make a change and send it back, that adds to the time it takes for your materials to be approved.
"My advice to sites, CROs, or sponsors submitting documentation to the IRB is to have a QC [quality control] system in place to make sure all the requirements are being met," Hart said. "Avoid having just one person responsible for the submissions; have a team meeting to review the documentation criteria and verify that all pertinent information is being provided in the correct format in a timely manner."
Even if the responsibility of IRB submission ultimately falls to you, try to enlist additional team members to help with quality assurance before you submit. You can also create a checklist for yourself of elements to double check as you're putting your IRB packet together.
One of the most important jobs of a clinical trial project manager is to communicate clearly and effectively with multiple stakeholders. For each piece of project, create a list of stakeholders, and take note of the kind of updates they'll need and how often they need to be updated.
In the RACI method of project management, you'll break stakeholders out into four categories based on their involvement in the project and communication needs.
As with any communication, knowing your audience is also a critical part of effective communication. Some stakeholders may prefer a weekly summary email over a weekly call, for example, or vice versa.
A paper on managing clinical trials published by the NIH also mentions the importance in a clinical trial of keeping the investigators themselves in the loop about the trial.
"Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy," the paper’s authors said. Because the investigators may also have busy clinical practices in addition to being part of the trial, it’s important to respect their time while making them feel involved and informed.
Another important communication piece for project managers is to share feedback from sites back with the sponsor of the trial. Communication is particularly important in relation to sharing updates with sponsors about recruitment or screening challenges at your site.
"Sites should update the status of referrals, why they screen failed, if they contacted them, because then they can feed those insights back to the sponsor," said Vanessa Lopez, account manager at Antidote. "Sometimes the sponsor will even take that feedback and make protocol adjustments."
Maintain a regular cadence of meetings or emails to share recruitment updates with the sponsor.
It's also crucial for a project manager to be knowledgeable about the details of a trial when talking with the sponsor. While you don’t have to go out and get a PhD in a scientific discipline, part of being a project manager is constantly learning on the job. Forte Research recommends that in discussions after a trial, the sponsor evaluate how well the site or CRO represented the sponsor throughout the trial. Talk with the investigators and do your own research on the trial before it starts so you can be as knowledgeable as possible with interacting with the sponsor.
Project management is an ever-evolving skill and there are lessons to be learned from even the most successful project execution, so it's important for project managers to evaluate each trial after it's complete, analyze trends, and plan for the next one. As Hubspot puts it, "a productive project post-mortem is a chance to fully unpack a project's trajectory and dig deeper into why things unfolded the way they did.”
You may want to host a project post-mortem meeting to involve key stakeholders in this retrospective evaluation. This meeting should be scheduled at the time you build out the full project plan, so that it is an anticipated part of the project wrap up. It's recommended that you send around a pre-meeting questionnaire to gather thoughts on what went well, what didn't, and what could be done better next time. Gathering this information ahead of time ensure that, even if your meeting is just an hour, all voices will be heard.
You'll also want to craft an agenda and appoint a moderator — someone who can keep discussions focused on the task at hand. The agenda should include a recap of the project's goals, including metrics, and a review of the results. You'll then want to dive into discrepancies between these goals and results. If you were looking to enroll 100 patients, why were only 80 randomized by the end of the project?
The point of this exercise is to ensure that key learnings are always being used to improve performance. This means that a post-mortem meeting requires a good amount of follow-up. Come up with actionable takeaways for the future, circulate them to all involved, and don't forget to look back for your next project.
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