Initiatives to Shorten Study Initiation and Patient Recruitment

Further, YCCI has adopted several NCATS introduced initiatives focused on shortening the timelines for study initiation and patient recruitment including: Accelerated Clinical Trial Agreement; Accelerated CDA; SMART IRB; Trial Innovation Network Umbrella CDA; FDP-CTSA Trial Innovation Network Standard Agreement; and the Accrual to Clinical Trials (ACT) Network (joined 2020 implementation in staging phase). https://ncats.nih.gov/ctsa/projects The CTSA Trial Innovation Network (TIN) Hub Liaison Team is embedded within the broad structure of the ORS “one stop shopping” model with offers ~30 services.

Beyond the NCATS introduced initiatives, YCCI has launched several other partnered initiatives focused on shortening the timelines for study initiation and patient recruitment including:

• Clinical trials activation (see below)
• Accelerate and enhance recruitment to clinical trials

As part of an institutional strategic plan to continue to grow clinical and translational research, YCCI in collaboration with OSP, Cancer Center, HRPP, and YNHHS conducted a targeted component review of all the activation steps required to initiate clinical research at Yale. The review, conducted with the support of a consulting group, identified 43 process improvements that would increase throughput and reduce rework significantly. Substantial improvements in research activation have been achieved, however to further enhance the overall activation process it was determined that YCCI should develop a new team to oversee the performance and management of all 12 operating units as it relates to activation, including the units in the three units outside of YCCI. YCCI has now established the new unit; set target activation timelines for all individual process components, based on three paths: existing master agreement, repeat and frequent sponsor, or new sponsor; and developed in partnership with Forte Research Systems dashboard visualize and monitor all the activations steps target vs actual across the entire clinical research enterprise. The YCCI unit will continue to optimize the activation processes until acceptable targets are reached across the enterprise.

Yale University has recognized the importance of implementing IRB reliance and pre-negotiated master contracts/subcontracts. To date, with help from the University’s legal office, 33 master agreements, have been put in place with industry sponsors. In addition, Yale’s IRB has 85 reliance agreements in place, most covering multiple protocols. The Yale Cancer Center has embraced these concepts as well and is participating in the full reliance and contracting models of the NCI-C IRB for Cooperative Group Studies. Under these agreements, it is now possible to gain approval for new studies in approximately one week. Yale now looks forward to actively contributing to the development of IRB reliance and pre-negotiated master contracts/subcontracts for the CTSA network as a whole (see letter of support). In parallel, the University. YM, and YNHHS have agreed on a standardized fee schedule for research including all technical and professional fees, making the budgeting process easy and transparent. The research fee schedule, managed by YCCI, is updated annually and can be accessed in OnCore by all authorized staff.

Recognizing that it will be necessary to streamline the approval process for multicenter studies, the University formed a committee in May 2015 to explore the use of central IRBs without diminishing the important work of the Yale IRBs. This committee conducted surveys of Yale faculty, research coordinators, and staff members of the Human Research Protection Program (HRPP) to understand the attitudes and perceptions on campus; worked with the Purchasing Department and the University’s legal office to issue a Request for Information from six commercial IRB vendors; and surveyed 41 academic medical centers to obtain a benchmark of practices at other institutions. The report described the unanimous agreement by the committee that, given the current nature of clinical research, the requirements of industry sponsors, and the feedback from other academic medical centers regarding fast turnaround times, it would be in the University’s best interest to allow the use of centralized and/or commercial IRBs. This initiative was viewed as an effective way to address the growth in investigator-initiated and industry-sponsored studies, remove barriers to investigators’ participation in sponsored research when central IRBs are required, and ensure Yale’s attractiveness and competitiveness as a research partner. Yale now has already contracted with the top 5 commercial IRB partners and, as part of the strategy, is currently seeking to expand this initiative further to additional IRB partners.