AN OVERVIEW OF THE CLINICAL TRIAL ENGAGEMENT NETWORK
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1 AN OVERVIEW OF THE CLINICAL TRIAL ENGAGEMENT NETWORK Gary Puckrein, Ph.D. President and CEO National Minority Quality Forum Salvatore Alesci, MD, PhD VP, Scientific & Regulatory Affairs PhRMA
2 Participation and Retention in Clinical Trials is Particularly Challenging among Minorities African Americans represent 12% of the U.S. population but only 5% of clinical trial participants Hispanics make up 16% of the population but only 1% of clinical trial participants By 2020, minorities are projected to account for over 40% of the U.S. population By 2050, Hispanics will make up to 29% of the U.S. population (emerging majority )
3 Key Environmental Drivers of the Need for Increased Diversity in Clinical Trials SCIENTIFIC Testing the safety and effectiveness of new medicines should accurately reflect the changing demographic of the patient population that will eventually take them REGULATORY Both domestically and internationally, regulators and other stakeholders are demanding more data from diverse populations ETHICAL Clinical trials in which minorities are underrepresented may not adequately serve the health needs of these communities OPERATIONAL Delays in recruitment costs billions and keeps novel therapies away from the patients that will benefit from them
4 Barriers to Diversity in Clinical Trial Participation Patient Socio-cultural: language, fear/mistrust (i.e. Tuskegee syphilis experiment) Economic barriers: patient costs (medical procedures and tests) and economic constraints (lost wages, lack of transportation, etc.) Individual barriers: lack of time, childcare, lack of information Institutional Provider relationships: minimal provider outreach in minority clinical trial recruitment Barriers in study design: clinic hours evening/weekend hours Organizational & resources: staff, funds and institutional status to facilitate opening a range of trials; and linguistically and literacy-appropriate information
5 The Current Clinical Trial Operational Model is not Best Suited to Address this Challenge Temporary networks Information highly siloed No capacity to effectively identify and distinguish communities with a unique risk for a particular disease
6 Clinical Trials Are Highly Localized 50% of all registration trials occur in 10 states 52% of all FDA drug trials occur in 445 zip codes (out of 38,000)
7 A partnership to increase diversity in clinical trials by raising awareness and connectivity among patients, sponsors, investigators, healthcare providers, their institutions and advocacy organizations across the nation The Campaign
8 I m In is a patient-centered community-focused campaign designed to improve health by increasing clinical trial participation among traditionally underrepresented populations, including individuals of varied races and ethnicities
9 Three-pronged Approach Digital Media Media Relations Advocacy We seek to engage a variety of organizations to serve as I m In Champions, including: Patient advocacy organizations Provider advocacy groups Clinical trials sponsors and researchers Member companies Elected officials
10 Digital Media Social Media Platforms Facebook: facebook.com/joinimin YouTube: youtube.com/joinimin Snapshot of Success Twitter followers: 692 Twitter impressions: 2,430,905 YouTube video views: 721
11 Engagement Opportunities Share Resources Engage on Digital Media Participate in/ Host Events Media Relations Distribute information to your members/contacts Have posters and/or brochures available for outreach Post about the campaign on your social media platforms Write a post for organization blog Add the campaign button to your website homepage Host an I m In representative at an upcoming member meeting or event Present I m In at an upcoming event Become an I m In media spokesperson Submit an opinion editorial or LTE to your local newspaper
12 Trial sites and investigators Pharma companies Points of care (i.e., hospitals, physician offices,) Patient communities
13 The National Health Index (NHI) A subsidiary of the NMQF with the goal to provide real-time information about the health of the American population, the care that they receive, and the trends that are shaping health status Millions of tables, maps, charts and graphs segmented by geography, age, gender, race and ethnicity The NHI provides demographic intelligence about infectious diabetes, heart disease, cancer, and other chronic diseases at the zip code level: Prevalence, costs, outcomes, Rx drug use and many other data sets to define the impact of disease by race/ethnicity, age and gender Identify unmet needs (i.e., undiagnosed populations) Forecast trends
14 The National Profile of Diabetes
15 Defining Lung Cancer at the Zip Code Level
16 Zip code-level Disease Mapping Helps Answer Important Questions Who? What? Where? When? Why?
17 What We Have Learned 70% of African Americans reside in 2,500 out of 38,000 zip codes 50% of Hispanics reside in 1,500 out of 38,000 zip codes These minority populations are served by approximately 500 hospitals and 40,000 primary care physicians
18 A community-centered physical and virtual network connecting patients and their advocacy organizations, research sponsors and investigators, healthcare providers and points of medical care to facilitate and accelerate diversity in participation to clinical trials: Built around data warehouse, analytic and communications systems Helps engage diverse populations who share a common disease experience Facilitates communications between researchers and community providers who serve those populations
19 CTEN Data Warehouse Core Components National Health Index (NHI) A comprehensive database defining disease prevalence by zip code powered by data gathered from electronic medical records, administrative billing data and consumer-originated data. Patient Registry A database of patients and healthy subjects from minority communities interested in participating in a clinical trial National Research Directory A relational database with full contact information for points of care, key opinion leaders, volunteer and faith-based organizations serving minority communities Investigator Registry A database of experienced investigators and physicians interested in becoming involved from minority communities
20 Clinical Trial Recruitment Center Unfettered access to the most comprehensive repository of minority-serving physicians, investigators, clinics and hospitals customized to meet the unique needs of your clinical trial teams
21 HOW PATIENT REGISTRY WORKS
22 CREATE A PATIENT PROFILE
23 PATIENT REGISTRATION PAGE
24 IDENTIFYING A DISEASE INTEREST
25 The Clinical Trial Engagement Centers (CTECs) Points of care located in diverse communities with access to large populations underrepresented in clinical trials: Capacity to conduct clinical trials or commitment to build capacity History of active engagement with their surrounding community Commitment to engage in campaign and contribute data (as appropriate) to the CTEN
26 ARE YOU IN?
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