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Targeted Strategies to Improve Physician and Patient

Access to Cancer Clinical Research

An Overview of Coalition Programs and Services An Overview of Coalition Programs and Services

Ruth LamberskyRuth Lambersky

Senior Project ManagerSenior 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 Websitewww.cancertrialshelp.org

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

www.ctsu.org

•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 SweepingQuery ResolutionScan Collection