Tufts CTSI Provides Researchers with a Toolkit to Reduce Study Startup Delays
The efficient study startup of clinical trials relies on engaging and coordinating the actions of a broad group of research staff and stakeholders. Unnecessary delays waste valuable research dollars and delay enrolling patients into lifesaving studies. The Research Process Improvement (RPI) team at Tufts Clinical and Translational Science Institute (CTSI) identified a knowledge gap: there was no single resource available to all research staff that provided an overview of the steps involved in the study startup process. Furthermore, research teams and research support staff seemed to only know the details of their role within this much larger process.
To address this gap, the RPI team worked with the Tufts Health Sciences Institutional Review Board (IRB) and staff in the Tufts Medical Center Neely Center for Clinical Cancer Research to understand the underlying factors behind delays in IRB turnaround time and study startup. After examining recent staff and operational changes in the Cancer Center, and interviewing researchers with recent IRB submissions, it was determined that many research staff struggle to efficiently complete IRB submissions, respond to IRB questions, and execute the many steps to launch a clinical trial.
With this information, the RPI team developed a comprehensive Study Startup Toolkit with detailed guidance on study startup including the IRB approval process. To ensure the toolkit accurately described the entire startup process and reflected the needs of teams across the organization, research staff from five clinical departments, Grants and Contracts, Finance and Budgets, the IRB, and Research Administration participated. The group focused on industry-sponsored clinical trials because of their complexity and the potential for delays.
The first step was to develop a high level process map of the startup process and inventory resource materials and standard operating procedures. Each participating group used the same format to organize background information and step-by-step guidance and resources. Information was organized to help investigators and research coordinators navigate the complex study startup process, coordinate team activities, and improve efficiency and quality.
During this process, the RPI team, a Tufts CTSI Senior Project Manager, and IRB staff worked to improve the results of the IRB Review Duration Common Metric. The group met quarterly to review run charts depicting the duration of recently-approved individual studies and track the progress of planned actions. The action plan included development of new guidance about responding to IRB Committee questions, process changes to prompt timely responses to questions, and resources for researchers.
It took about a year to develop a high-level study startup process map (see Figure 1) and a comprehensive toolkit with step-by-step guidance, templates, tools, forms, and tips. Each process map step is a clickable link to detailed guidance and resources. The process map and toolkit address the identified gaps in knowledge for study teams and staff.
One of the most detailed sections of the toolkit is the guidance offered on IRB submissions (See Figure 2). The toolkit consolidates in one place the resources about submission to the local IRB or a commercial IRB, or about proposing a single IRB. IRB resources to reduce IRB Review duration are also included, and the toolkit reinforces procedural changes required with the launch of a new electronic IRB system. The IRB staff believes the frequent focus on the metric helped them reduce the IRB Review duration, and they support integration of IRB resources into the toolkit.
The toolkit is centrally located on the Tufts Medical Center intranet and includes links to Tufts-specific resources and to external resources for each step of the study startup process. The startup process map illustrates how different steps in the process can move forward in parallel, thereby reducing delays. The process begins when a Confidentiality Disclosure Agreement is received and concludes when the study begins participant enrollment. Tufts CTSI services, such as Regulatory Support, are featured throughout the toolkit. The toolkit is now used by clinical departments to onboard new study coordinators and investigators, and we are considering adapting the current toolkit for non-industry sponsored studies. Study startup metrics will be collected in a newly-implemented Clinical Trial Management System to help assess the efficiency of the startup process in the future.
• Centralized resources like this toolkit can reduce variation in study startup across organizations with a decentralized research structure and assist investigators when onboarding new staff.
• Close monitoring of potential sources of study startup delay, such as delays in the IRB review process, can help determine if the actions being taken to reduce delays are effective.
• The Study Startup Toolkit, although specific to Tufts CTSI and Tufts Medical Center, can serve as a template for other hubs looking to reduce delays in study startup and IRB review duration.
The Tufts CTSI RPI team has shared sample pages of this resource in the CLIC Resource Library. The full version of the toolkit is available by contacting Alyssa Cabrera at firstname.lastname@example.org