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The redundancy of process and documentation for activating trial sites has been an issue in the past as it can lead to delays in trial initiation. Rapid study startup can illuminate these inefficiencies by removing or reducing non-value tasks.
One of the most persistent bottlenecks in clinical research is the redundancy of processes and documentation for activating trial sites. For a typical study involving multiple sites, a trial sponsor (or its CRO proxy) requires all sites to submit investigators’ medical licenses, confidential disclosure agreements (CDAs), CVs, training records, feasibility surveys and other documents at the start of every study. Such requests can be quite burdensome for trial sites, and often delay trial initiation.
Instead of reaching out for all that information every time we engage an investigator for a study, why not ask for it once? That is the basic premise of rapid study startup (RSS), a process designed to make site activation more efficient by eliminating or reducing non-value-added tasks, particularly those that are redundant or repetitive. The RSS framework is a client-oriented approach resulting from a thorough analysis of the entire site activation process across multiple stakeholders. At its core is technology, with all documentation collected once and stored in a repository.
As the term implies, RSS is a more streamlined approach that eliminates waste and accelerates site activation. Since January 2016, when we started offering RSS services, average startup times dropped by one-third when combined with the use of a preferred group of high-performing investigators. These same sites also typically became the most reliable and enthusiastic enrollers. For all trials enrolling subjects since January 2016, the preferred sites were activated in just a couple of days and enrolled, on average, twice the number of subjects in about half as many locations, compared to non-RSS sites.
Identifying and Securing High-Performing Sites
Building an alliance of high-performing sites was critical to our RSS deployment and required a disciplined approach that involved extensive vetting. Before we invite a site to join this alliance, we review and evaluate data from previous studies conducted over the past five years, focusing on metrics such as number of studies and the number of enrolled patients. The vetting process also includes qualitative assessments of factors such as recruitment efficiency, turnaround times and site staff interest, receptiveness and willingness to collaborate and cooperate. Those that emerge from this rigorous process as a top-performing site are those that we invite to join the network.
The site visits are crucial for making subjective, qualitative assessments and gauging investigators’ and supporting staff members’ professionalism. Through focused questioning, we can determine whether a site is professionally managed and staffed by growth-oriented individuals who bring an entrepreneurial spirit to their business. Site visits also help us assess the degree of stability among research coordinators and whether the site maintains good relationships with principal investigators (PIs).
Personnel and Technology
Effective deployment and implementation of RSS requires a dedicated person to manage processes and relationships with the trial sites. Our director of site services is responsible for coordinating agreements, visiting the sites, assessing investigators and serving as primary point of contact for the PIs and study coordinators. This channel of communication allows investigators to review new opportunities as they come in, whereby we present the protocol and supporting materials and solicit investigator feedback.
We also deploy a team of clinical trial assistants (CTAs) to assist with RSS setup and internal communications and to help sites assemble dossier packages, licenses and other documents.
Much of the information gathering is conducted electronically, using advanced technologies to monitor the sites and examine cycle times and other pertinent metrics. Our CTAs also use our clinical trials management system (CTMS) to build a repository of medical licenses and other materials.
Refining the Process
While deployment of RSS has been extremely successful thus far and well received by sponsors and investigators, we now aim to engage sites earlier in the planning process. Previously, we would approach a site when a study was relatively close to startup. We now take a more holistic view of the business development cycle, which can take upwards of 18 months from opportunity identification, to first contact, to RFI and RFP, to negotiation. By approaching sites earlier in the cycle, we can present our pipeline to investigators so they have an earlier view of forthcoming opportunities.
One key learning is that we need to encourage PIs to communicate with their research staff about the rationale and potential benefits of RSS. Whereas we would previously communicate directly with the PIs, in many cases we found that the PIs had not informed their staff that they had committed to RSS. By fostering a true dialogue between PIs and staff, we can secure staff buy-in to the RSS concept.
Such a dialogue is important for enrolling patients faster, which remains a challenge. While advanced technology can facilitate enrollment in certain situations, there is no substitute for effective communication with site management, which needs to understand that physician involvement is crucial to patient recruitment and enrollment. That makes the pre-initiation visit especially important, though once we have worked with a site without difficulty, we can be confident that we can do so again on subsequent studies.
Ultimately, the success of RSS depends on continuous assessment. That involves critical analysis of individual sites’ performance as well as a more holistic assessment at the macro level, whereby we examine aggregated data from all study sites and compare performance among different studies. By keeping study highlights and lowlights on our analytical dashboard, we can help individual sites improve their performance as well as enhance overall efficiency study-wide. Such refinements should help us continually improve RSS.
Kurt Mussina, General Manager, Frenova Renal Research