CONTRIBUTED SESSION 1

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1 IMPROVING TRANSPARENCY IN CLINICAL TRIAL COSTS FOR PARTICIPANTS: NATIONAL CANCER INSTITUTE (NCI) NATIONAL COVERAGE ANALYSIS INITIATIVE SUPPORTED BY THE NCI S CANCER TRIALS SUPPORT UNIT Lawrence R Ragard Westat, Inc. - Clinical Trials Area Background: Clinical trials billing compliance is a high-risk area for oncology research programs and requires completion of a financial coverage analysis to identify billable and non-billable tests/treatments within a research trial prior to activation. In an effort to eliminate the redundancies and reduce the burden associated with coverage analysis development for research sites, the National Cancer Institute (NCI) tasked the Cancer Trials Support Unit (CTSU), a contract held by Westat, to implement a National Coverage Analysis (NCA) Initiative. Representatives from the NCI, NCI s National Clinical Trials Network (NCTN), organizations, NCI Community Oncology Research Program (NCORP) research bases, CTSU staff, and a billing consultant formed a working group to develop and harmonize the process for the CTSU to provide coverage analyses to institutions participating in NCI-sponsored clinical trials. The CTSU deployed the NCA initiative in April Methods: The CTSU staff use the study protocol, NCI funding sheet, and informed consent form to draft the NCA. The CTSU staff review these documents to ensure they are consistent, and then define interventions as either billable to insurance, sponsor paid, provided, or funded, or not billable. To determine if an intervention is billable, the CTSU staff adheres to the Centers for Medicare and Medicaid Services (CMS) published National Coverage Determinations (NCDs) that define what interventions are billable to Medicare. The CMS Clinical Trial Policy includes a National Coverage Determination (NCD 310.1) that delineates routine costs in a qualifying clinical trial. Unless a service can be documented as being reasonable and necessary to diagnose or treat a condition, the service is assumed to be done for research purposes only and not billable. Other resources include the National Comprehensive Cancer Network and American Society of Clinical Oncology guidelines, and recommendations from articles in peer-reviewed journals. CTSU staff maintain close collaboration with representatives from NCI s NCTN organizations and NCORP Research Bases in the review and approval process of the coverage analysis documents prior to making them available to the research institutions. CTSU staff strive to have the NCA document posted on the CTSU website at study activation for institutions to use as part of their study activation process. The CTSU creates the coverage analysis document at the national level to assess coverage of interventions in a clinical trial. Research and billing staff remain responsible for addressing institutional guidelines and local coverage determinations (LCDs) from the regional Medicare Administrative Contractor jurisdictions for their area. Site staff have identified the regional differences in LCDs and various investigator opinions about standard of care as key challenges affecting clinical trial costs and limiting participation in clinical trials. Results and Conclusions: The CTSU has posted over 150 NCA documents on the CTSU website. NCI s coverage analysis effort reduces the unnecessary duplication of efforts across research institutions, improves transparency of the financial implications of trial participation for both the institution and potential study participants, increases clinical trial billing compliance, and reduces the barriers to clinical trial participation. Lawrence R. Ragard (Westat, Inc.) Margaret Camarca (Westat, Inc.) Polly Ke (Westat, Inc.) Lucille Patrichuk (Westat, Inc.) Marge Good (National Cancer Institute)

2 Grace Mishkin (National Cancer Institute) Andrea Denicoff (National Cancer Institute) CROWDSOURCING SOLUTIONS FOR RCT STUDY START-UP PAIN POINTS Diane B Hartford University of Utah - Pediatrics Introduction A multi-disciplinary group, from the Utah Trial Innovation Center (TIC) and Data Coordinating Center (DCC), created a process map of their study start-up process. Under the guidance of a Value Engineer, the group applied process problem-solving strategies to map out study start-up of a RCT (randomized controlled trial). Once completed, the group used the process map to identify process delays and crowdsource solutions to leverage the expertise and support of personnel for new ideas. Method The group began by identifying delays in the process of getting a study up and running. One area of delay was finalizing the set of clinical data elements (CDEs) needed to build the database in the electronic data capture (EDC) system. For context, clinical data elements are selected prior to the database build. However, when changes or additions are made to the CDEs after the database build, the database must be revised, re-reviewed, and re-tested. These revisions require additional time and effort not only to update the database but also to revise other downstream start-up deliverables dependent on the CDEs (e.g. rule writing for queries, site data collection forms, training materials, Manual of Operations, etc.). Next, the group created a fishbone diagram to identify barriers that delayed the finalization of CDEs. These barriers included: 1) the current process of selecting CDEs, 2) expectations of stakeholders, 3) expectations of principal investigators, 4) organizational culture, 5) feasibility of collecting needed data, and 6) lack of planned analyses around study outcomes. To identify and target solutions with the greatest potential, the group chose the CDE finalization process as an area of focus. In order to crowdsource improvement ideas, the Innovation Team at the DCC utilized its web-based idea management software platform called IdeaScale. Crowdsourcing refers to outsourcing work, in this case problem-solving, from a small group to all members of an organization (the crowd). In June 2018, the group launched a campaign soliciting ideas from the staff of the DCC on how to improve the process of finalizing CDEs. Results DCC faculty and staff, numbered at 121 people, submitted 13 ideas, commented 70 times on the ideas, and upvoted ideas 149 times. The importance of commenting and upvoting ideas is that staff engage in discussions about how to further refine ideas. The Innovation Team reviewed all ideas, plotting them on an impact vs. effort grid. The ideas that fell into the high-effort/low-impact quadrant were removed from consideration. Next, the barriers identified from the fishbone diagram exercise were mapped to the remaining ideas. Six of those ideas addressed the barrier of process, the area of focus identified earlier. These ideas were then presented to organizational leadership and two of them are currently being implemented. Summary Process improvement methodology paired with crowdsourcing initiatives have the potential for targeting value-driven initiatives, which leverage the collective expertise of a specific group. In turn, this may allow for better

3 solutions, engagement, and more effective change management of new initiatives. Diane B. Hartford (University of Utah) Marie Kay (University of Utah) Luca Boi (University of Utah) Jeri Burr (University of Utah) J. Mike Dean (University of Utah) THE NEURONEXT MODEL: EFFICIENCIES GAINED BY DEPLOYING AN EMBEDDED RESEARCH ADMINISTRATOR Krista Valladares Massachusetts General Hospital - Neurological Clinical Research Institute (NCRI) Research Administration differs in composition and execution across institutions. Although some Research Administrators (RAs) are located centrally, others are specialized within a department or PI-specific portfolio. RAs are experts on all things grant-related and there are many efficiencies that can be gained by utilizing RAs. The NeuroNEXT Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC) have dedicated RAs that manage pre-, peri- and post-award activities for the Network s operational infrastructure and the network-funded studies. The DCC RA is a member of the Network s executive committee and oversees the feasibility process for proposals in the pipeline. NeuroNEXT RAs collaborate with all Protocol PIs (PPIs) and their RAs on proposal development activities and advise on the project s administrative composition throughout the submission process. During the peri-award activities, when funding is imminent, the NeuroNEXT CCC RA works closely with the Project Management team to get start-up activities underway, and both CC RAs begin preparing administratively to start the study. The embedded RAs track the study using the budget and justification and manage milestones included in the NOA; using these documents as a project road map facilitates the RAs role of guiding the study teams to fulfill their federal reporting obligations and conduct their trial as effectively as possible. The RAs expertise is essential during the fast-moving post-award phase of the study as they advise study teams and PPIs on the budgetary implications of protocol changes, drug supply considerations, enrollment delays, and the overall study timeline from a financial standpoint. To effectively manage these moving targets, the CCC RA participates in weekly calls with the study teams for the Network s active trials. Both CC RAs are contributing members of the network s Operational Leadership team which meets monthly, and they regularly connect one-on-one to coordinate responses to action items that span both portfolios. Now that NeuroNEXT has nine funded studies, the embedded RAs serve as the institutional memory for project development, where lessons learned from earlier studies are used to strategically inform new proposals and studies in start-up. The embedded RAs have harmonized aberrant grants management functions, including transferring two prime awards for studies in recruitment and follow-up while striving for minimal interruption to the studies. Additionally, the embedded RAs navigated the implementation of the infrastructure s renewal awards, onboarding of eight new Network sites which included establishing Master Clinical Trial Agreements, user agreements, and training for site personnel in an expeditious fashion to enable the participation of new sites on active studies. This

4 demonstrates that research does not stop at the scientific idea and that RAs are an essential part of any successful research team. RAs are multi-disciplined administrators who can adapt and respond to the needs of research teams in roles including grant writing, compliance, and finance. Deploying the embedded RA model in multi-site trials and clinical trial networks enhances the overall efficiency and success of scientific research efforts. This proposal will illustrate the importance of an embedded RA and highlight the efficiencies gained by employing this model in multi-site trials. Krista. Valladares (Massachusetts General Hospital) Maggie Spencer (University of Iowa) ANALYSIS OF DRUG LABELING FOR INFORMATION SPECIFIC TO GERIATRIC POPULATIONS Jacqueline L Chen University of Southern California - Department of Regulatory and Quality Sciences Geriatrics are historically underrepresented as clinical trials (CT) participants implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 called for greater CT inclusion and reporting of demographic subgroups, including geriatrics. To assess adherence, content of geriatric drug labels approved from was evaluated for geriatric-specific information. To understand FDASIA Section 907 s impact, we compared labels approved before ( ) and after implementation ( ), to identify trends of geriatric inclusion in CT over time. We examined geriatric subsections of drug labels approved from in 4 areas: 1) reporting of CT including geriatrics, 2) reporting of percentage of CT participants age 75+, 3) providing geriatric dosage recommendations, 4) determination of product safety/efficacy for geriatrics. 151 labels from , and 99 from were analyzed. Of all labels assessed, 26% did not report CT including geriatrics. 45% did not report including CT participants ages % did not provide geriatric dosage recommendations. 38% indicated insufficient evidence to determine product safety/efficacy for geriatrics. Although we expected more geriatric labels fulfilling areas examined over time, there was no consistent increase across in any of 4 areas examined. Labels providing geriatric dosage recommendations was consistently the least fulfilled area across all years. As there was no considerable difference in drug labels fulfilling areas examined before and after 2015, FDASIA implementation may not have impacted geriatric inclusion in CT for drugs approved between Since many of these CT began prior to FDASIA 2012 signing and 2015 implementation, we expect to see the legislation s full impact in future years. Inadequate language in geriatric labels represent knowledge gaps for clinicians and regulators and could contribute to adverse drug events in geriatrics. There is an increased need for regulatory incentives and mandates for CT involving geriatrics. Jacqueline L. Chen (University of Southern California) Amelia Spinrad (University of Southern California) Nancy Pire-Smerkanich (University of Southern California) Eunjoo Pacifici (University of Southern California)

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