BioNJ’s Health Equity in Clinical Trials Initiative Overview 

• NJ Baseline – BioNJ will ascertain a baseline of New Jersey’s diversity in clinical trials versus other states from which to build.
• MBA Business Plan Competition – BioNJ introduced a first-of-its-kind MBA Business Plan Case Competition to promote the next generation of diverse clinical trial innovators and deliver useful protocols and successful models that can be used nationally to strengthen diversity in clinical trials and expand health equity.
• Connecting the Dots – BioNJ will facilitate Connecting the Dots via a virtual platform featuring projects that our companies are undertaking for sharing of information and cross collaboration.
• Trust – Building trust is critical and must be built into each facet of the plan. This will be an overarching theme and incorporated into all aspects.
• Directory – Directory of ideas and talent as well as recognizing the efforts of individuals (including winning ideas, entries, competition participants, sponsors, and volunteers)

Health equity is achieved when every person has the opportunity to “attain his or her full health potential” and no one is “disadvantaged from achieving this potential because of social position or other socially determined circumstances.”

Health inequities are reflected in differences in length of life; quality of life; rates of disease, disability and death; severity of disease; and access to treatment.

*CDC: https://www.cdc.gov/chronicdisease/healthequity/index.htm

Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry

“The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan… to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials.”

“FDA advises sponsors to seek diversity in clinical trial enrollment beyond populations defined by race and ethnicity, including other underrepresented populations defined by demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity.”

Source: U.S. Food & Drug Administration, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

The Drug Development/Clinical Trial Process & Impact

Clinical Trials – What You Need to Know Video

Download a pdf of PhRMA’s whitepaper  The Impact of Industry-Sponsored Clinical Trials

Status of Clinical Trial Recruitment

Clinical Trials Remain Unrepresentative – while the FDA, NIH, and other federal agencies identified insufficient demographic diversity in clinical trials as being a significant priority in 1993, further progress is needed.

Table 1. Percent Participation in Clinical Trials by Subpopulation for New Molecular Entities and Therapeutic Biologics Approved in 2020.

* The percentage of all other races combined (American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, Other, Unknown/Unreported) makes up 100% of race category.
*The percentage of Non-Hispanic and Unknown/Unreported ethnicity makes up to 100% of ethnicity category.
*The percentage of Patients from anywhere else in the world makes up to 100% of geographic category.

Download a pdf of the Steering Committee List.

Partnership Benefits for All Sponsors

• Beneficiary of the five key deliverables from the initiative (NJ Baseline, MBA Business Plan Competition, Connecting the Dots, Trust and Directory)
• Inclusion of Partner Organization’s Health Equity-related initiatives on BioNJ Health Equity web portal (thousands of global visitors expected on a monthly basis)
• Corporate logo on Health Equity web portal
• Recognition at MBA Business Plan Competition (reaching students in MBA, PharmD and MD programs from partner universities) and other initiative events
• Opportunity to distribute Health Equity-related whitepapers (sent to ~15,000 names) and thought leadership via BioNJ social media (reaching 8,000+ users across five platforms)
• Participation in collective effort towards generating solutions and innovating
• Inclusion in op-eds highlighting New Jersey’s leadership role in HEQ

In addition to the above, the following Sponsorship Categories receive:

Champion – $100,000 – Limited to 6

• Organization featured as Champion and Trusted Advisor on all promotional and informational materials
• Leadership role in BioNJ’s Health Equity in Clinical Trials Strategy
• Seat on BioNJ’s Health Equity in Clinical Trials Strategy Steering Committee
• Key role in determining direction of the work
• Organization representative prominently featured at related events and on all materials promoting the effort
• Organization featured as a Founder of the MBA Business Plan Competition
• Opportunity to serve as a Judge for MBA Business Plan Competition
• Opportunity to showcase organization’s efforts to increase diversity in clinical trials during MBA Business Plan Competition
• Opportunity to interact with students directly during the MBA Business Plan Competition

Changemaker – $75,000

• Organization featured as Changemaker on all promotional and informational materials
• Seat on BioNJ’s Health Equity in Clinical Trials Strategy Steering Committee
• Key role in determining direction of the work
• Organizational representative featured as Committee Member on Health Equity web portal
• Organization featured as a Supporter of the MBA Business Plan Competition
• Opportunity to serve as a Judge for the MBA Business Plan Competition
• Opportunity to interact with students directly during the MBA Business Plan Competition

Connector – $50,000

• Organization featured as Connector on select promotional and informational materials
• Seat on BioNJ’s Health Equity in Clinical Trials Strategy Steering Committee
• Organizational representative featured as Committee Member on Health Equity web portal
• Organization featured as a Supporter of the MBA Business Plan Competition

Contributor – In Kind

• Organization featured as an In-Kind Contributor on select promotional and informational materials
• Opportunity to contribute tangible efforts to move the work forward
• Organization featured as a Supporter of that specific area of work of contribution