Building Clinical Infrastructure and Expert Support Michael Steinberg, MD, FACR ULAAC Disparity Project Centinela/Freeman Health System

Functional Specifications Address Limitations Budget Personnel Availability Develop Job Titles and Descriptions

Developing Functional Specifications for Implementation of Clinical Trials Generic for all Clinical Trials Implementation Specific to Disparity

Specifications and Requirements a. Responsible for promoting and maintaining good communication with physicians and patients regarding clinical trials b. Prepare reports, documents, and other data required for departmental administration. c. Participate in the Cancer Program’s ongoing Quality programs. d. Responsible for and participates in the management of data collection, analysis, monitoring case management of protocol patients, recruitment or enrollment of human subjects, development of informed consents, preparation of adverse event experience reports, or audit; construction or monitoring of case report forms; oversee maintenance of drug records; education of other health care professionals, patients of family. e. Recruitment and randomization of oncology patients. f. Ensure accurate delivery of Research forms, radiation Therapy and Pathology required by National Groups. g. Assist at audits required by National groups, presentation of materials. h. Responsible for review of treatment charts for accuracy in the delivery and recording of treatments. i. To inform the respective National Groups, National Cancer Institute, and Institutional Review Board of Deviations of adverse reactions of participating patients. j. To prepare all protocols for Institutional Review Board approval. k. To modify all patient consents in accordance with the law in the state of California and within the bounds of DFMH. l. To maintain the protocols in an orderly fashion so they are easily and readily available to physicians. m. Coordinate activities of Protocol patients at other research sites. n. Educate patient and family of patient on study o. Ensure accurate delivery of results of research to the Institutional Review Board on an ongoing basis. p. Maintain and deliver all official forms with the Department of Health and Human Services for all physicians involved in existing research programs. q. Maintain and deliver all required forms for the Protection of Human Subject. r. Supply pharmacy with appropriate protocols concerning non-commercial and commercial drugs. s. Order investigational drugs as needed for protocol purposes.

t. Periodically review navigator function in successful accrual to clinical trials u. Evaluation in determining the eligibility of patients to the research programs. v. Interviewing and assisting each prospective patient – Adult and Geriatric. w. Discuss program with prospective physicians concerning patient referral to Research Program. x. Prepare reports, documents, and other data required for departmental administration. y. Participate in the Cancer Program’s ongoing Quality programs. z. Responsible for and participates in the management of data collection, analysis, monitoring case management of protocol patients, recruitment or enrollment of human subjects, development of informed consents, preparation of adverse event experience reports, or audit; construction or monitoring of case report forms; oversee maintenance of drug records; education of other health care professionals, patients of family. aa. Recruitment and randomization of oncology patients. bb. Ensure accurate delivery of Research forms, radiation Therapy and Pathology required by National Groups. cc. Assist at audits required by National groups, presentation of materials. dd. Responsible for review of treatment charts for accuracy in the delivery and recording of treatments. ee. To inform the respective National Groups, National Cancer Institute, and Institutional Review Board of Deviations of adverse reactions of participating patients. ff. Prepare culturally and linguistically appropriate educational materials gg. To modify all patient consents in accordance with the law in the state of California. hh. To maintain the protocols in an orderly fashion so they are easily and readily available to physicians jji. Coordinate activities of Protocol patients at other research sites. kk. Educate patient and family of patient on study ll. Ensure accurate delivery of results of research to the Institutional Review Board on an ongoing basis. mm. Maintain and deliver all official forms with the Department of Health and Human Services for all physicians involved in existing research programs. nn. Maintain and deliver all required forms for the Protection of Human Subject. oo. Supply pharmacy with appropriate protocols concerning non-commercial and commercial drugs. pp. Order investigational drugs as needed for protocol purposes. qq. Periodically review investigational drug logs and inventories with pharmacy staff to assure that appropriate documentation is maintained and that federal guidelines are being met rr. Evaluation in determining the eligibility of patients to the research programs. ss. Interviewing and assisting each prospective patient – Adult and Geriatric. tt. Discuss program with prospective physicians concerning patient referral to Research Program.

Develop Job Titles and Descriptions Clinical Research Coordinator Clinical Nurse Specialist Community Health Educator

Clinical Research Coordinator Coordinates data management activities. Coordinates administration and outcome of clinical studies. Assures administration of IRB regulations, departmental guidelines for the CDRP project. Completing regulatory requirements for research approved by the project IRB Transcribing information from patient charts to a Case Report form Act as a "coordinator" helping to screen for patients in the Radiation Oncology service Assisting with informed consent, ordering tests, collecting data and producing reports of final data

Clinical Nurse Specialist Serve as the primary contact person for patients enrolled in the Project Responsible for ongoing medical and social needs assessments Assist entering data into Project database. Serve as administrative liaison and coordinate services for Project enrollees. Work with patients in clinical settings in the Project target community Supervise of the Patient Navigators assigned to the patients enrolled in project. Responsible for ongoing coordination of care, telephone follow-up, patient education, data collection, quality assurance, report preparation, and individual patient Care plan preparation.

Health Educator Reviews available education materials about clinical trails Develops appropriate new materials for these subjects assuring cultural and linguistic integrity Develops community physician education about the Project Develops patient education regarding clinical trials and the program in physician offices Coordinates Navigator activities and outreach in the community Coordinates community outreach

Expert Support – Identifying Partners Rationale for Partner Selection Particular experience Resources Research know-how

Characteristics of Partners Partners Will Be Actively Involved In: (1) development and conduct of the clinical trials (2) assessment capability as to the extent to which the Project reaches out effectively to target population persons 3) preparing Project outcome products (4) help with RO1 applications

Mutual Benefits to Partners (1) opportunity to collaborate in research findings (2) opportunities to develop competence to more effectively diminish disparity (3) mutual educational opportunities (4) opportunities to increase experience in the use telemedicine and teleconferencing technologies (5) increase accrual to existing national and partner institution clinical trials (6) partners to increase tertiary referral (7) opportunity for partner to increase its interaction with the local community as it monitors and evaluates the process and impact of the Project on patients, community-based practitioners and the partner institutions so as to develop policy and programmatic recommendations with regards to disparities in cancer treatment and access to clinical trials.

How Partners Will Contribute to Achieving Project Goals Serve as members of the Project’s Clinical Advisory Council Clinical trials capability Provide health services expertise that will enable more effective project-community linkages Facilitate Program monitoring and evaluation to develop pertinent policy recommendations

Community Expertise Faith based organizations Public health organizations Community action groups Community based patient support organizations and groups Community organizers and leaders