Welcome to the CoC Web Conference

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• Welcome to the CoC Web Conference
• Increasing Clinical Trial Participation
• Our Program Will Begin at 900 am (Central Time)
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• Host Kate Phair
• Company American College of Surgeons
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• Thank you.

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A Web Conference for CLPsIncreasing Clinical
Trial ParticipationSeptember 17, 2008
9/03
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Objectives

• Have a comprehensive understanding of the ACS's
  clinical trials matching service and trial
  database.
• Be able to describe relevant NCI clinical trial
  educational resources for use by health care
  professionals.
• Better understand the tools available to help
  identify cancer clinical trials for patients
  quickly and accurately.
• Have a greater knowledge of how physicians
  influence the patients' decisions to enroll in
  clinical trials studies.

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Presenters

• Katie Dalquist, American Cancer Society
• Katie.Dahlquist_at_cancer.org
• Larissa Tis, Coalition of Cancer Cooperative
  Groups
• ltis_at_cancertrialshelp.org
• Rose Mary Padberg, National Cancer Institute
  Cancer Information Service
• padbergr_at_mail.nih.gov
• Karen Torges, EDICT Backpack Project
• Karen.Torges_at_cancer.org

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• American Cancer Societys
• Clinical Trials Matching Service
• September 2008

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Why Are We Doing This Work?

• Educate patients and health care professionals
• Increase enrollment in clinical trials
• Identify barriers

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Why Are We Doing This Work?

• Support Better Decisions
• Provides an easy and efficient way to search for
  treatment clinical trials
• Research
• Connects patients to current research projects
• Helps research studies accrue patients in a
  timely manner
• Quality of Life
• Helps patients navigate through the clinical
  trials system
• Assists patients in finding supportive care
  clinical trials
• Prevention and Detection
• Provides information on prevention and early
  detection research studies

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Highlights of the CTMS

• Help patients understand the purpose of clinical
  trials
• Help screen patients for the clinical trials most
  appropriate to their needs based on their
  diagnosis, previous treatment and geographic and
  study preferences
• Ability to look up trials by protocol ID, drug,
  disease and location
• Coordinate clinical trial information with other
  aspects of cancer information and patient
  services (e.g., support groups, lodging,
  transportation, etc.)
• Provide information by Internet and phone to
  include groups currently under-represented in
  clinical trials
• Track national trends and identify deficiencies
  in screenings, eligibility and enrollment based
  on age, gender, disease, ethnicity, location, and
  many other factors.

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CTMS How It Works
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Screening Questionnaire

• Demographic information
• Gender
• Date of birth
• Zip code
• Cancer type
• Cancer subtype
• Cancer stage
• Previous treatment
• Activity level
• Interest in Phase I trials

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CTMS Information Packet
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Resource Information

• CTMS Team
• http//clinicaltrials.cancer.org
• 800-303-5691
• Monday Friday, 730 a.m. 700 p.m. CT
• Brochures
• For physicians -- Referring Your Patients to a
  Clinical Trial
• For patients -- Is a Cancer Clinical Trial the
  Right Choice for Me?

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Additional Resources

• Katherine Sharpe Health Promotions, Business
  Development Director
• Melissa Fellers Mission Delivery Manager
• Katie Dahlquist Team Supervisor

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THANK YOU!
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Clinical Trials Tools and Services

• Coalition of Cancer Cooperative Groups
• September 17, 2008

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Mission Statement

• A non-profit organization whose mission is to
  increase survival and improve the quality of life
  of cancer patients through increased
  participation in cancer clinical trials
• The voice for cancer clinical trials.

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The Coalition

• Led by 10 Group Chairs
• Representing 8,000 clinical researchers in 1,800
  sites in U.S.
• Patient Advisory Board
• Representing 65-80 advocates throughout coop
  group system
• 50 Friends of the Coalition Advocate
  Organizations
• Scientific Leadership Councils in GI, Lung,
  Breast
• Corporate and foundation support
• Working relationships
• American Cancer Society, Leukemia Lymphoma
  Society, Georgia CORE, IMPAC Medical Systems,
  National Cancer Institute, WebMD, CureToday.com,
  HealToday.com

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TrialCheck
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TrialCheck

• Cancer clinical trials information and software
  linking patients and physicians to trials.
• Launched November 2001
• Only not-for-profit cancer clinical trials
  matching service

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TrialCheck Unique in the Marketplace

• Comprehensive
• Thousands of trials including cooperative group,
  NCI and industry
• Precise
• Unique search algorithm eliminates trials for
  which patient is not eligible
• Customizable
• Defined users may code and enter intramural
  trials for local viewing
• User-friendly
• Patients and clinicians alike praise ease of
  search
• Updated help files and glossary to support
  patient and public searches
• Accessible on PDA

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TrialCheck Data Overview
Up-to-date performance sites
Cooperative Groups
Real-time
PDQ/ NCI (Clinical Trials.gov via PDQ)
Accurate protocol status
TrialCheck
Weekly
Precise screening
On demand
Comprehensive trial list
Pharma / Biotech
Quality Control Cleansing and Review Process
Confidential
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TrialCheck Matching Criteria

• Screen trials for patients using standardized
  eligibility criteria
• Cancer Type/Sub-type
• Age
• Prior treatment history
• Performance status
• Stage

Confidential
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TrialCheck Search Options

• Search by
• Protocol ID
• Performance site
• Anatomical site
• Drug
• Location city, state, zip

Confidential
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Creating Efficiencies

• Maintain institution-specific trial listings
  coded to meet standardized
• eligibility criteria
• Electronically track screenings, eligibility and
  enrollment of patients onto
• clinical trials
• Access on-demand to reporting regarding
  screening, eligibility, enrollment,
• and trial-related information
• Provide patient community access to trials at
  your institution via
• customized, framed interface in your website

Confidential
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(No Transcript)
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American Cancer Society
Confidential
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State of Georgia
Confidential
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TrialCheck

• Atlantic Health Sciences
• Carol G. Simon CC
• Cedar Rapids
• Hackensack
• Joan Karnell
• Warren Hospital
• Winchester Hospital
• South Western Vmt MC
• Mountain States Tumor
• Institute St. Lukes
• Gibbs Regional CC

Confidential
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Tracking Screening, Eligibility Enrollment

• TrialTracker, Web-based system
• Customized for institution (only those trials
  open and enrolling
• locally)
• Extensive reporting capabilities
• High-level How many screenings were completed
  in a
• given period of time
• Detail level How many African American Women
  were
• screened for X trial during a period of time

Confidential
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h
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TrialCheck Integrated With EMR

• IMPAC Medical Systems
• The only clinical trials system fully integrated
  with an electronic medical record application.
• All diseases
• Customized to be only those trials open and
  enrolling patients at
• the specific institution
• Real-time web services

Confidential
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TrialCheck
IMPAC EMR
Screening Window
Confidential
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Physician Impact on Enrollment
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Physician Encouragement

• 84 of patients enrolled in cancer clinical
  trials were encouraged by physician
• Where physician was neutral on enrollment
• 66 patients declined
• 18 tried to enroll
• 16 enrolled

• Where physician discouraged enrollment
• 100 patients declined

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Physician Effort to Educate

• Physician made moderate effort
• 41 enrolled
• 41 declined
• 18 tried to enroll
• Physician made great deal of effort
• 64 of patients enrolled
• 11 tried to enroll
• 25 declined

• Physician made little effort
• 69 declined
• 22 enrolled
• 9 tried to enroll

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• National Cancer Institute Educational Resources
  on Clinical Trials
• Rose Mary Padberg, RN, MA
• Clinical Trial Support Coordinator
• Office of Communication
• and Education

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Clinical Trials Education Series
DVD
Slideshows

• 20 multi-media resources
• Train-the-trainer program
• Targeted education and outreach

Workbooks
CD
Brochures/Booklets
Online course
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The Basic Workbook

• For
• Individuals wanting to develop a basic
  understanding of clinical trials
• Content
• Clinical trial process
• How clinical trials lead to advances in care
• Participant protection
• Barriers to participation
• Finding clinical trials
• Exercises and reviews

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The In-Depth Program

• For
• Health care professionals
• Others seeking a more in-depth understanding of
  clinical trials
• Content
• Same as basic workbook and more designing a
  trial and interpreting results
• Conducting, locating, and referring to trials
• Case study

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A Resource Guide for Outreach, Education, and
Advocacy

• For
• Individuals and organizations engaging their
  communities in clinical trials outreach and
  education activities
• Content
• Educating yourself and others
• Reaching underserved populations in your
  community outreach
• Working with the media
• Working with medical organizations

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Easy-to-Read Brochures

• For
• Cancer patients considering a clinical trial
  (English/Spanish)
• Medicare recipients considering a clinical trial
• Content
• What are clinical trials?
• What are my rights?
• What are the risk and benefits?
• What questions should I ask?
• What does Medicare pay for?

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Cancer Prevention Brochures

• For
• Healthy people who are at high risk for cancer
• Content
• What are prevention clinical trials?
• What will I be asked to do?
• What are my rights?
• What questions should I ask?
• Available in English and Spanish

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Providing Your Tissue for Research What You Need
To Know

• For
• Investigators
• Individuals who have been asked to provide tissue
  for research
• Content
• A targeted list of questions and answers on how
  and why tissue specimens are collected and used
  in research

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NEW! Taking Part in
Cancer Treatment Research Studies

• Updated look and text from original booklet
• Geared toward patients considering participation
  in a clinical trial
• Defines a clinical trial, discusses what to
  expect, and lists things to consider

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Understanding Cancer Clinical Trials DVD

• 17 minute DVDreplaces two videos
• Helps staff discuss clinical trials with
  potential participants
• Complements new booklet for potential clinical
  trial participants
• Format allows for skipping to specific sections

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Slide programs (English)

• Cancer Clinical Trials The Way We Make Progress
  Against Cancer
• Cancer Clinical Trials The Basics
• Cancer Clinical Trials In-Depth Information

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Slide programs (Spanish)

• Conversemos un ratoInformación para combatir el
  cáncer en su comunidad
• La historia de JoséY cómo él ayudo a encontrar
  nuevas maneras de prevenir el cáncer
• La historia de AnaY cómo ella recibió
  tratamiento para el cáncer

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Clinical Trials Education Series CD
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Web course

• Incorporating Cancer Clinical Trials Into Your
  Practice www.cancer.gov/clinicaltrialscourse

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PDQ Clinical Trials RegistryInformation Resource
and a Service

• Resource for patients and health professionals
• Identify clinical trials that may be an option
  for cancer-related care
• Service for investigators and other NCI
  Divisions
• PDQ helps meet trial registration mandates under
  FDAMA 1997, FDAAA 2007, ICMJE 2005 and 2007

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PDQ as an Information Resource

• Registry is a large and dynamically growing
  database
• 7,000 active trials
• 17,500 closed or completed trials
• 75 -100 new trials submitted directly to PDQ
  monthly
• 150 trials are added monthly from
  ClinicalTrials.gov
• 5,000 trials have links to 10,824 published
  results (citations in PubMed and ASCO meeting
  abstracts)
• Average of 180,000 searches a month on the web
  site
• Includes many types of trials
• Treatment, Diagnostic, Screening, Prevention,
  Supportive care, Genetics
• Behavioral studies, Educational/counseling/trainin
  g
• Natural history/epidemiology
• Biomarker/laboratory analysis, Tissue
  collection/repository
• Health services research

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To Order CTES Materials

• Free copies are available
• Call 18004CANCER
• Go to www.cancer.gov/publications

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Eliminating Disparities in Clinical Trials(EDICT)

• BackPack Project

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Goals

• To compile evidence based, best or promising
  Policies, Practices, Programs, and Projects that
  have been shown to help eliminate disparities in
  recruitment and retention of underrepresented
  groups in clinical trials.
• To make these resources available to researchers,
  advocates, policy makers, and healthcare
  providers.

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You can use the EDICT BackPack to

• Access Web-based resources to help eliminate
  disparities in clinical trials and other
  research.
• Identify potential partners with whom to consult
  or collaborate.

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For more information, contact

• Rosanne Trost, RN, MPH
• EDICT BackPack Project Manager
• Tel [phone]
• E-mail edictbackpack_at_bcm.edu
• www.bcm.edu/edict/backpack

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Presenters

• Katie Dalquist, American Cancer Society
• Katie.Dahlquist_at_cancer.org
• Larissa Tis, Coalition of Cancer Cooperative
  Groups
• ltis_at_cancertrialshelp.org
• Rose Mary Padberg, National Cancer Institute
  Cancer Information Service
• padbergr_at_mail.nih.gov
• Karen Torges, EDICT Backpack Project
• Karen.Torges_at_cancer.org