69 - IRB-Industry Collaboration: Lessons Learned

Background: Bottlenecks in the review of industry-initiated studies delay IRB approval and study initiation. The informed consent document, for example, requires multiple rounds of revisions about issues that could instead be addressed at the sponsor and institutional level. Our IRB addresses this and similar bottlenecks through greater IRB and industry collaboration.

Program

Description: Our sponsor collaboration program is multifaceted and includes several stakeholders from the institution, IRB, and industry sponsors.

First, we select industry sponsors with the highest IRB submission volume. Then, in partnership with other institutional stakeholders, we identify sponsor representatives responsible for regulatory submissions and site-initiation. Next, we propose a solution to the sponsor, negotiate terms of agreement, and determine program evaluation measures. After implementation, we meet regularly to evaluate and iterate.

The Master Consent Program (MCP) is our most recent sponsor collaboration initiative. We work with several sponsors to address the delays resulting from the back-and-forth between the IRB and sponsors in the review and approval of informed consent documents. To establish this program with each new sponsor, we negotiate one common template for use with the sponsor including approval of standard template language, and work with institutional and sponsor stakeholders to agree on the implementation and evaluation process.

Program

Assessment: Our sponsor collaboration program leverages existing relationships between industry sponsors and the institution. Our MCP mirrors the approach of Master Trial Agreements. Since sponsors are already familiar with this approach, many are receptive to applying it to different elements of the IRB approval process. We analyzed 25 sponsors and identified five for the pilot phase. Two sponsors refused, one was unresponsive and we launched the pilot with two sponsors.

Sponsor and institutional legal departments are receptive and helpful during the negotiation process and meet our deadlines 90% of the time. The delays we encountered during the first attempt at implementing the program were largely due to the organization of individual sponsors rather than the general IRB-industry collaboration program.

We assess the program by tracking several metrics for each project. To assess the MCP, we track the number of IRB clarification requests, the time from IRB submission to approval, and the IRB determination (outright approval vs clarifications requested).

Limitations: Direct collaboration is not possible for every sponsor. Some are decentralized, which increases the complexity of negotiations and prohibits uniform submission standards. Other sponsors’ rigid processes hinder negotiations.

The project also does not work well with sponsors who submit a smaller volume of studies since the return on investment is unfavorable.

Lastly, the program is time-intensive, requiring ongoing communication between the IRB and sponsors to address any institution-level changes that may alter previously-settled agreements.

Discussion: Engaging directly with sponsors can be an effective way of reducing or eliminating many study-level roadblocks that IRBs, study teams, and sponsors encounter during the review and approval process of individual studies.

Furthermore, the logic of the program is clear to sponsors and the legal representatives of both sponsors and IRBs. We intend to use this as a tool to address other issues that result in delayed IRB approval of industry-initiated studies. Other institutions can adopt this approach to improve their own IRB review process and decrease turnaround time.