Involving Patients in the Research Process Beverly Canin Breast Cancer Options, Inc Breast Cancer Action Cancer and Aging Research Group U13 Meeting 2015 Chicago

What Does It Mean? Google: “Involving Patients in the Research Process” – 33 Google Scholar :– 12 Google: history of “Patients in Research” – 141,000 history of “Patient Collaboration in Research” – 2 Google: “Patient Collaboration in the Research Process” – 37,800,000 Google Scholar: - 746,000 Google: “Patient Advocate Collaboration in the Research Process” – 4,340,000 Google Scholar: - 109,000

Overview Recruiting Older Patients into Clinical Trials –What they want –Trial Design –Impediments Patients and Patient Advocates as Research Partners –Benefits –Types of Partnerships/Roles –Support/requirement from funders

OVERVIEW (cont) Patient-centered Outcomes Research Institute (PCORI) Experience – University of Rochester Communicating on Aging and Cancer Health (COACH) –Stakeholders for Care in Oncology and Research for our Elders (SCOREboard) advisory committee Future Needs –Educating Researchers and Clinicians –Educating Patients and Patient Advocates

Recruiting Older Patients into Clinical Trials What do they want? –No easy answer; it’s a heterogeneous population –Biomedical vs. behavioral concerns –Next generation and generation after Trial design –Simple and direct –Easily translatable

Recruiting Older Patients into Clinical Trials Systemic Impediments –Skepticism and suspicion –IRB’s - slow processing and complicated requirements are very hard on the elderly Different institutions have different rules Could centralization or regionalization for more consistency alleviate delays? –Consent forms are too onerous – who are they protecting? – Dr.’s often don’t know the details of the trials they are recruiting for. More education needed. – Options to the standardized clinical trial protocol should be considered

Patients/Advocates in Research Benefits –Humanize the science –Interpreters for the lay community –Contribute ethical concerns –Build public support –Help disseminate findings in culturally appropriate ways

Roles of Patients/Advocates in Research Participants in a study Consultants for a study as individuals or in groups, one-time or on-going Influence clinical practice guidelines Peer review panel members

Patients/Advocates in Research Programs/Trainings/Peer Review ASCO patient advocate program AACR patient advocate program NCI – Council of Research Advocates –Office of Advocacy Relations – h-advocacy/research-advocacy-101 National Breast Cancer Coalition – DoD Congressionally Directed Medical Research Program – Project LEAD

Patients/Advocates in Research Programs/Trainings/Peer Review California Breast Cancer Research Program (CBCRP) Alamo Breast Cancer Foundation (San Antonio Breast Cancer Symposium) Susan G. Komen for the Cure Dr. Susan Love Research Foundation Cochrane Library HealthNewsReview.org Research Advocacy Network

SCOREboard SCOREboard Structure –Possibly a unique model SCOREboard Accomplishments – Acronym, logo, brochure, consent forms, study protocol, role play survey questionnaire, CRA guide for recruitment, role play recruitment Future Plans –Establish consulting team for one-on-one or group work with CRA’s –Document our experience in a handbook

PCORI Survey PCORI Patient-Centered Methods in CER Evidence-to-Action Network (E2AN) –Ways of Engaging- Engagement Activity Tool (WE-ENACT) – -Methods-CER-E2AN-Webinar-Audio MP3 –who what when where challenges facilitators

Summary. Much progress has been made in building infrastructures, but still need to connect the dots –Researchers and clinicians need to be made more aware of the feasibility and benefits –Training in partnerships needs to be easily accessible and started early in researchers’ careers –Stakeholders need to know there are programs and trainings to help them become effective research partners.

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