OHSU investigators often participate in clinical trial projects, many of which are sponsored by industry partners looking to investigate new drugs and devices. The studies are an important step in the process of determining the safety and efficacy of therapies as they move toward FDA approval. It’s essential, then, that all components and functions of the clinical trial process work smoothly and efficiently.
Moving swiftly through the start-up phase of industry-sponsored clinical trials is fundamental to successful execution of the project. That said, the study start-up phase requires significant administrative and logistical work.
A reorganization of OHSU clinical research administrative support services was designed to streamline processes like contract negotiations with principal investigators, industry sponsors and contract research organizations.
The Clinical Research Services Office was launched in July 2017 to bring clinical research support functions under one umbrella and focus on partnering with the research community to support OHSU’s commitment to clinical research.
Turnaround time for clinical trials contracting:
— FY18 actual: 86 days
— FY18 goal: 90 days
— FY16 actual: 112 days
Significantly cutting contract turnaround times was goal no. 1 for Eric Smith, when he first accepted the role of director of the Clinical Research Services Office in fall of 2017. The contracting unit negotiates and signs all industry-supported clinical trial agreements. Shortening the time it takes to work through contracting could dramatically improve the end-to-end clinical trial process, as well as OHSU’s ability to enroll subjects as a significant site for multi-center trials.
Smith’s team has responsibility for contract negotiations, which take place simultaneously with eCRIS administration and the IRB approval process. Once the contract negotiation is final, contract execution still requires having completed approvals from eCRIS and the IRB. With many moving parts, this complex startup process can suffer from confusion in communication and responsibilities.
The Clinical Research Services Office has been working to clarify these issues by building stronger partnerships with investigators and leading a culture change in how clinical research works between central offices and the decentralized study teams. Study teams and central services are being encouraged to collaborate and see themselves as a part of the same team, pursuing common goals, rather than adversaries and gatekeepers.
The Clinical Research Services Office is making progress. In the fourth quarter of fiscal year 2018, the contracting team exceeded the University’s ambitious target of a 90-day turnaround time, achieving an 86-day average turnaround. The drop represents a significant improvement over last year, when contract processing might not begin for three or four months after submission. Contract processing now typically begins within a week or two. The goal for fiscal year 2019 is still being set, but the team aims to cut more days from the process.
With contracting times now improving, the Clinical Research Services Office is setting a new focus for FY19: improving clinical research billing compliance and accuracy, in a way that simultaneously reduces the burden on study teams and improves study subject experiences.