1 Targeted Strategies to Improve Physician and Patient Access to Cancer Clinical Research An Overview of Coalition Programs and Services Ruth Lambersky Senior Project Manager An Overview of Coalition Programs and Services Ruth Lambersky Senior Project Manager

The Coalition A non-profit organization striving to improve physician and patient access to cancer clinical trials through Education Outreach Advocacy Research

  Represent the interests of clinical researchers and cancer patients   Led by chairs of 10 Cooperative Groups   ACRIN Board Member Mitchell Schnall, M.D., Ph.D.   Guided by Patient Advisory Board   2 Leads from each group   112 advocates throughout the groups   50+ Advocate Organizations   Scientific Leadership Councils   in Breast, Lung & Colorectal Cancers   Funded through   Grants and sponsorships from companies, government, and foundations   Contracts with government and Fee-for-Service agreements with organizations and companies   Member dues Who We Are

Main Public Message Cancer Clinical Trials are a treatment option to consider at the time of diagnosis and throughout a patient’s course of treatment because they provide the potential for cutting-edge medical treatment and the highest level of care.

Regulatory Support for the Groups and their Physician Members   Sub-Contractor to NCI’s Cancer Trials Support Unit (CTSU)   Central repository for Coop Group regulatory documentation TrialCheck®   Online navigation and matching system   Free public service for all from a credible, reputable, non-profit   Customizable for advocates, public health orgs and others (by fee) Scientific Leadership Councils   Consensus forums to identify best direction for the science   Known for naming High Priority trials currently underway   Breeding ground for generation of new study concepts Programs and Services

Advocacy & Educational Services   High quality science based training workshops for advocates at all levels   Online self study modules for cancer research topics   Consumer education for ongoing trials and emerging data   Physician-physician CME programs   Policy leadership at national level and across Groups Knowledge is Power!   National awareness campaign with Newsweek and others Alpha Oncology - subsidiary clinical research organization Programs and Services (cont’d)

Clinical Trials Workshop   For community-based researchers setting new programs or improving existing ones   Co-Sponsored with ASCO and ONS ASCO’s Annual Clinical Trial Participation Awards   Sponsored by the Coalition   Over 50 research sites have received the award since its inception   For excellence in accrual, high quality audits, success in recruitment of minority populations Summit Series   Issues forums among a network of 350+ advocates   Co-Sponsored with ASCO, ONS, Cancer Leadership Council and Prevent Cancer Foundation Guidance Documents   Policy-focused guidance for lawmakers and advocates   “Elements of Success” guidance for clinical research sites   With C-Change, the Summit Series and The Lewin Group Co-Sponsored Programs

Putting high-quality information into the hands of patients is our goal The vast majority of cancer treatment information in the public domain either describes clinical trials as a last resort—or simply fails to mention clinical trials as a treatment option, thus most cancer patients never learn about the opportunity

Coalition Website

Cancer Trials Support Unit NCI Pilot Project initiated in 1999 and awarded to WESTAT and the Coalition Provides greater access to Phase III clinical trials sponsored by the National Cancer Institute (NCI) Performs comprehensive clinical trials management that will ease and facilitate participation by investigators and provide quality data to the Cooperative Groups Serves as the interface between the operational, statistical and data management centers of the Cooperative Groups and the network of investigators enrolling patients 76 active protocols from the Adult Cooperative Groups, NCI Cancer Consortia, DCP Coalition processes all regulatory documentation for the Adult Cooperative Group Studies

Alpha Oncology is a contract research organization (CRO) that provides oncology clinical trial and site management services that enhance interactions between industry and Cooperative Group Members. Services provided for the cooperative groups to date: Data Sweeping Query Resolution Scan Collection