The goal of this sub-project was to evaluate whether or not some of the gains achieved by Mayo clinic through their full-scale ACTION, Accelerating Clinical Trials Integration and Overcoming Non-value, project could be translated into wins for the Yale Cancer Center clinical service office, and therefore potentially other similar research enterprises (CTSA’s, NCUI CC’s, etc.), without completing the full scale project. Our intention, however, was to examine the pre-and post review activities of both Center offices for novel processes and tools to utilize toward improving the services offered, tracking of regulatory activities, timelines to completion, efficiency of service, and positive collaboration with other related offices (grants and contracts, finance).
In the fight against cancer, Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for cancer treatment. Yale Cancer Center harnesses the resources of the Yale School of Medicine and Yale-New Haven Hospital to advance cancer research, prevention, and patient care, as well as community outreach and education.
The Clinical Research Services (CRS) office of the Yale Cancer Center is a Shared Resource that provides centralized management of all clinical trials performed at Yale Cancer Center. The staff of research nurses, data managers and administrative assistants offers complete support for clinical trials, including: preparation and submission of protocols to review committees, filing of all regulatory documents, establishment and maintenance of research files, completion of case report forms, design of data entry forms, medical record abstraction, preparation of reports and analysis, coordination of monitoring visits and audits, as well as patient education, monitoring and follow-up. The staff has expertise in coordinating industrial, cooperative group and Yale-initiated studies. The office is experienced in all phase studies of drug development and in coordination of multi-center studies. Stacey Scirocco, the Yale lead for this project, was the Associate Director of the Yale Center for Clinical Investigation- which has strong regulatory and finance collaborations with YCC- throughout most of the project. Before her tenure at YCCI she was in the administration of the YCC for 8 years and currently she works for both Centers as the Associate Director for Scientific Review Committees in the Office of Protocol Review and Monitoring at Yale.
The Mayo Clinic Cancer Center is a National Cancer Institute (NCI)-designated comprehensive cancer center with a multisite presence. Its three campuses — in Scottsdale, Ariz.; Jacksonville, Fla.; and Rochester, Minn. — give the Mayo Clinic Cancer Center a broad geographic reach, enabling it to serve diverse patient populations around the country and the world. The campuses are also home to outstanding internationally recognized physicians and scientists who collaborate across the full spectrum of cancer research, from basic biology to treatment, as they seek ways to reduce the burden of cancer. Mayo Clinic is a leader in translating knowledge gained from cancer research into effective improvements in patient care. Each year, Mayo Clinic treats about 20,000 cancer patients, making it one of the largest cancer treatment facilities in the United States.
Mayo Cancer Center Clinical Research Office (CRO) supports researchers and patients by providing centralized management and oversight functions related to the conduct of clinical trials. The CRO provides a comprehensive infrastructure to support clinical trials by offering the following services to facilitate and strengthen research: protocol development and maintenance support; regulatory and compliance support; data systems management; study coordinator support for screening, enrolling, and monitoring patients; quality control checks throughout the life of the protocol; education for staff as well as users of the resource; operational support including business and administration systems and processes; and information systems support. Kelly Paulson is the Administrative Director of the office and was the team leader for the Mayo side of the project.
Mayo ACTION Project Background
The Mayo “Accelerating Clinical Trials Integration and Overcoming Non-value” or ACTION project was a quality improvement initiative started in 2009 in the Mayo Cancer Center with the goal to reduce the time and effort from concept to study activation by at least 20% for new research protocols entering the system beginning on December 31, 2009 without sacrificing quality, safety, or compliance with regulatory and institutional requirements. Accomplishments included:
- 50% + improvement in timeline
- One budget / one contract / one signature for multi-site participation
- Earlier logistics meeting to set timelines, responsibilities
- Standardized review at Disease Oriented Groups, including accrual potential
- Improved collaborations and communications with industry partners
- Elimination of duplicate systems and processes
- Protocol management tools and dashboard
We utilized monthly conference calls, annual (sometimes twice-annual) face to face meetings and electronic mail to develop the project and conduct the work.
We began by reviewing the details of the ACTION project including the work plan, value stream mapping that was conducted, the resulting findings, Kaizen organization by theme, and resulting tools and successes. Midway through our collaborative engagement, Yale initiated a quality improvement project for the post IRB approval functions of the Clinical Research Services (CRS) office and the results and resulting tools and processes were shared with Mayo clinic.
In the next stage we had detailed discussions about each office’s organization and processes and very quickly discovered processes that were novel on both sides and were thought to have some benefit to the either organization. Next we physically exchanged all of the desired knowledge and processes for, as one example, the study operalization meeting, tools, such as the time, task and effort calculator (one of the tools further shared on this site), and guides such as the list of suggested dashboard events to track. We then worked to implement these and utilized each other for assistance.
Each site was able to utilize a process or a tool to make the other entity’s operations more efficient, faster, or more accurate. In many cases knowledge gained affected multiple processes. In the time that this ACTION collaboration has been active, Yale initiated its own quality improvement cancer center initiative, which was unanticipated at the start of the project. Mayo’s ACTION initiative was targeted to pre-IRB functions of getting a study to activation, while Yale’s initiative was more targeted to post IRB approval functions of managing active studies. Therefore, we were able to share both projects and their successes and this work of seeing what of Yale’s project is usable at Mayo continues. Likewise, as Ms. Scirocco now manages the pre-study implementation scientific review functions of the Cancer Center, the intent will be to utilize even more of Mayo tools and processes resulting from the ACTION project as well as these developed relationships on an on-going basis.
- A lot can happen over a 2 + year period. The operational environment you are working in could change substantially over a multiyear project and it is important to continuously re-assess goals and plan for such changes.
- Site transferring tools/processes gains feedback and suggestions for improvement from receiving site.
- Receiving site needs to anticipate need for modifications specific to site use, including wording, intended audience, systems, etc.
- Other projects and information were identified for future sharing as the project progressed; formalized relationship to continue.
- Fostering relationships at like organizations provides an objective but relevant source for discussion and mentorship.
- Mayo ACTION project presentation
- Yale Quality Improvement resulting tools and applicability
- Mayo Cancer Center CRA time and task calculator
- Mayo CC Protocol Fees Spreadsheet
- CRA protocol fees and time and task calculator help doc
- Mayo timeline tracking dashboard events
- Mayo-Yale ACTION project poster presentation, June 2011