Study Activation: A Complex Process That Doesn’t Have to Be Painful
Study activation data from the Forte community shows on average, it takes about six months to activate a new, interventional, treatment clinical trial. Long activation periods are not a new trend – in 2008, Dr. David Dilts’ findings showed it took hundreds of steps to activate an NCI-funded trial at a single site. This was just to get the study open to accrual, not to conduct the study. He also found that not all steps added value to the process. To make his point, he charted the study activation process and when he was done, it was 50 feet long by 5 feet tall and in 8-point font! If the clinical development time of a new treatment is to ever decrease, reducing the time in study activation is necessary so actual research can be done.
Study activation is a cross-functional process and generally includes some sort of scientific review; cancer centers have a protocol review and monitoring committee (PRMC), and non-cancer programs often utilize an academic department or disease team review process. There are many other reviews, varying based on the protocol type, target population, organization, and geographic location that contribute to the study activation process. These reviews may include pharmacy review, ancillary service review (e.g., surgery, pathology), institutional biosafety committee (IBC), radiation control, medical imaging, and protocol feasibility. For any clinical trial, ethical review by the institutional review board (IRB) is required.
Additionally, a budget must be determined, and if industry-sponsored, negotiated with the sponsor. To effectively do this, items like a Medicare coverage analysis (MCA) must be performed as well as a determination of staff and procedure costs to the research organization. Along with the budget, the contract must be negotiated. For some trials, this is a federally funded grant proposal that needs to be accepted. For others, it is a trial-specific contract with a sponsor. Consider organizational, local, and state laws, as well as data entry/submission requirements, data/specimen use, and the negotiated budget. Recognize that this isn’t an all-inclusive list but gives an idea of the complexity involved.
Even with completed reviews, consider other logistical items, including:
- Electronic health record (EHR) notification
- Setting up study records in the clinical trial management system (CTMS)
- Participant binders
- Regulatory binders
- Case report forms (CRF)
- System access
- Pharmacy notification
- Research team and ancillary service training
- Site initiation visit/sponsor training (SIV)
Reading this list, the complexity is clear: When discussing the need for these processes, each seems rational and necessary. However, if each of these processes is not considered within the whole context of activating a protocol, the process quickly becomes cumbersome and slow, bogged down with redundant steps, adding little to no value to the overall process. Reviewing and scrutinizing each step of the process maximizes efficiency, ensures compliance, and minimizes the time it takes to properly activate a study. Aligning goals and creating understanding about why specific processes add value to study activation across the organization engages all involved personnel. This shared platform removes the hostility associated with the competitive pressures of activating a clinical trial. People are then able to focus on how they are assisting in the progression of science and human health within their communities and beyond.
However, it is difficult for most organizations to dedicate the personnel and time to thoroughly review policies, processes, and discussions with stakeholders to provide feedback on optimizing the study activation process. Engaging an external party with knowledge and objectivity regarding the study activation process can jump start the organization with unbiased recommendations and a plan to improve the organization’s process and make them more competitive in gaining desired clinical trials.
Clinical research enterprises that come together under common goals and shared understanding can transform the study activation process. Instead of a frustrated, finger-pointing argument of who’s taking too long, the process can be improved to an understanding of the essential activities and their purposes with collaborative teamwork and communication across the organization’s research enterprise. This culture of shared understanding, ethics, and risk tolerance will ensure that top quality research will be performed. How is your organization’s study activation process?