Our understanding of disease treatments cannot advance without successfully carrying out clinical trials. Study start-ups can quickly become a tenuous undertaking if the trial project management process is not carefully constructed from the beginning. Here are five common project management mistakes and how your trial can avoid or overcome them.
What is Clinical Trial Project Management?
Clinical trial project management is a process that encompasses the coordination of all aspects of a clinical trial, including the time and development costs involved. This process is composed of five basic phases:
- Project conception & initiation
- Project definition & planning
- Project launch or execution
- Project performance & control
- Project closing.
Now, let’s dive into the five common project management mistakes that occur within clinical trials.
Mistake #1: Not Setting Realistic Timelines
Accurately factoring in time is essential when the goal is a smooth clinical trial launch. Although starting the study as soon as possible seems ideal, setting unrealistic timelines is counterproductive. Some delays are inevitable, but if you don’t plan your timeline appropriately to prepare for them, they can cause significant frustration for the sponsor and even interested site investigators. Prepare a realistic timeline by carefully gathering extensive information from experienced team members and from challenges faced in previous projects to guide your project timeline.
Mistake #2: Inefficient Recruitment Plan
Inefficient patient recruitment plans and insufficient enrollment numbers are leading causes of project delays in 80% of clinical trials. To avoid this major pitfall, take a multipronged approach to guarantee maximum efficiency in your recruitment plan before the start of enrolment. Ensure the study design is patient centric and incorporates the patient’s perspective, spread the word to local healthcare providers and patient support groups, develop a variety of media for marketing materials, and utilize central call centers to streamline the process of determining eligibility for potential participants. At each step, always consider the right technology, such as patient databases with smart filters, site EMR databases, and free user-friendly study management platforms like VialConnect.
Mistake #3: Not Clearly Outlining Your Stakeholders
With projects as large and complex as clinical trials, multiple individuals are invested in the success of the study’s launch, even if their roles don’t entail managing the day-to-day details. When these stakeholders are not properly outlined, the project manager is more likely to experience miscommunication errors, inefficient email time management, and general disorganization when maintaining contact with all interested parties. You can avoid this mistake by first outlining your stakeholders using the RACI method; for each project component, determine who is responsible, accountable, consulted, and informed. Appoint the individual responsible to act as a liaison for that component. Remember to manage varying expectations and agendas among your shareholders by maintaining clear communication and developing a concise trial management plan supported by everyone.
Mistake #4: Using Paper-Based Management
Another one of the most common mistakes in clinical trial project management is relying on paper methods of documentation. This antiquated approach is ultimately too time-consuming and inefficient given the complex heavy workload involved with trial management. Moreover, a system of physical documents lacks structure with little ease of accessibility to the valuable information contained within. Instead, switching to digital technology maximizes the potential of your clinical trial. Tools such as electronic data capture (EDC) and electronic source (eSource) house the same information but also provide cross-platform support. By choosing to rely on innovative clinical trial technology, time-consuming, manual data monitoring becomes a structured, all-inclusive software-based workflow that maximizes productivity and minimizes errors.
Mistake #5: Not Having the Right Technology
More important than just switching to digital methods of trial management is working with the most appropriate platforms. Not all clinical trial technology is created equal and not having the right one results in project disorganization, delays, and team miscommunication. An ideal solution is to use a clinical trial management system (CTMS). All-inclusive CTMS platforms, such as VialConnect, are a one-stop shop seamlessly incorporating key tools, including eSource, EDC, electronic trial master file (eTMF), and electronic patient-related outcomes (ePRO). Look for a system that is compatible with your communications platform, is cloud-based, integrates with your existing solutions stack, and can evolve with your project needs to help manage multiple ongoing trials.
Conclusion
Project managers play a pivotal role in streamlining the clinical trial management process and knowing the common pitfalls can help reduce any unforeseen challenges. To maximize the success of your study, be sure to create realistic timelines and recruitment plans, streamline stakeholder communication, and incorporate digital-based technologies. Getting a clinical trial off the ground is no easy task, but with the right preparation and the right tools, it can be managed smoothly. VialConnect CTMS was built to level up your trial operations by centralizing, simplifying, and automating your essential project management needs. Connect with a team member today to learn more!
