Duplicate regulatory processes can delay the start of multisite clinical research. Reliance agreements among the UC campuses for the Institutional Review Board (IRB) are one way to reduce the time it takes to initiate a clinical trial, but what about the other necessary reviews? Under the guidance of UC BRAID and the UC Cancer Consortium, UC Davis and UC San Francisco explored the possibility of a consistent approach to coverage analysis, a necessary but sometimes time-consuming process for sponsored clinical research agreements. The UCD-UCSF Coverage Analysis Comparison Pilot Project aimed to explore the similarities and differences in the coverage analysis (CA) process for an oncology clinical trial that was concurrently open at both UCD and UCSF.

​

To determine the consistency in coverage analysis processes and the possibility of sharing coverage analysis decisions across campuses, a few factors were explored. Among the key findings of the pilot project:
 

1. Background and Training of CA Developers: Neither UCD nor UCSF requires prior medical coding experience for CA developers, relying instead on robust internal training programs. However, UCSF offers additional certification through Advarra, providing a pathway for professional development.

2. Methodology and Workflow: Both sites utilize dedicated teams for CA development, with UCSF employing a more specialized approach across different teams. Documentation and reference to guidelines like NCCN and FDA package inserts are common practices in both locations.

3. Content and Form Differences: While both sites use a range of common documents (protocol, ICF, guidelines) for CA development, there are notable differences in billing designations and the use of the term “not billable,” impacting how costs are allocated and documented.

4. Operational Differences and PI Preferences: UCSF’s approach to CA is generally more segmented between coverage and budgeting tasks compared to UCD’s integrated approach. Preferences around the structure and presentation of CAs also varied, reflecting different operational cultures.

5. Commonalities and Recommendations: The project highlighted several areas of common practice, such as the use of similar documents and the sequence of procedures listed in the CAs. Recommendations for future projects include exploring mixed billing studies and further standardizing CA processes and billing designations to enhance consistency across UC sites.

 

​The pilot project underscores the potential benefits of harmonizing CA processes across different UC sites to streamline operations and ensure consistency in clinical trial billing practices. Future efforts will focus on expanding comparisons to include more diverse study types and incorporating additional UC sites to broaden the scope of the analysis.