# Presentation: 076848

## Slide 1

##    EVIDENCE THAT DEMANDS A VERDICT:  BIDIL AS A CASE FOR INCREASING MINORITY PARTICIPATION IN CLINICAL TRIALS

-    **EVIDENCE THAT DEMANDS A VERDICT:  BIDIL AS A CASE FOR INCREASING MINORITY PARTICIPATION IN CLINICAL TRIALS**

## The Current Picture:  
Industry Reality

**Industry Reality**

**“****No data available” is frequently cited**
**“****We can’t find ‘em”**
**“****We get our drugs approved anyway, so why bother?”**
**The race debate in medicine, “aren’t we all the same?”**
**Average is < 5% in pivotal trials supporting drug safety and efficacy**

## The Current Picture:  
Minority Perspective

**Minority Perspective**

**“****I don’t want to be a guinea pig”**
**Lack of education about the process and value-added benefits of participation in clinical trials**
** ****Lack of critical mass of minority physicians (particularly those doing research)**
**Negative experiences with health care system**
**Distrust due to tarnished industry image in the media**

## The Current Picture:  
FDA & NIH Perspective

**FDA & NIH Perspective**

**1994 NIH Guidelines on the inclusion of women and minorities in clinical trials required analysis of race and ethnicity but no requirement regarding degree of representation**
**1997 FDA Modernization Act required FDA and NIH to consult on inclusion of women and minorities in clinical trials**
**FDA supports it, encourages it, would like to see > of it but no mandate currently exists**

##  Why we should all be concerned

**Lack of minority physician and consumer participation affects:**
**Product development, standard of care**
**Product approvals (including those based on non-US data)**
**Targeted therapies based on genetics**
**Increasing evidence that race & ethnicity does matter in pharmacological treatment**

## BREAKING THE CYCLE

**Increasing Participation and Community Trust**

**Health**
**disparities**

**Poor trial**
**Recruitment**
**and retention**

**Overlook**
**differential**
**impact of**
**diseases by race/**
**gender/ethnicity**

**Perceived lack**
**of caring**
**affecting trust**

**Health system**
**unresponsiveness**

- Source: Office of AIDS Research, National Institutes of Health

## 
Is the product safe? 
Is the product effective?
Is the dose correct?
Is this the best therapy?
For me?............
  With approval of BiDil for the treatment of CHF in African American patients, the answer is YES!!! 

**Is the product safe? **
**Is the product effective?**
**Is the dose correct?**
**Is this the best therapy?**
**For me?............**
**  ****With approval of BiDil for the treatment of CHF in African American patients, the answer is YES!!!**

## Evidence that Demands a Verdict

**BiDil as “Exhibit A” demonstrates that race does matter in pharmacological treatment**
**A “representative sample” was key to identifying superiority of BiDil in African Americans**
**Trial stopped early due to overwhelmingly positive efficacy and safety**
**BiDil will save African American lives and reduce disparities**
**BiDil will give M.D.s greater confidence**

**Evidence that Demands a Verdict**

## Evidence that Demands a Verdict

**In approving BiDil, the FDA has a rare opportunity to make available a drug that has been shown to benefit African Americans with CHF, a population at high risk of disparate outcomes including premature death**
**Nitromed’s successful attempts to recruit African Americans in the BiDil clinical trial should serve as a model for concerted efforts to recruit minorities usually underrepresented in clinical trials**

**Evidence that Demands a Verdict**

## Recommendations

**Minority Community Perspective**
**Become informed & consent to participate**
**Pharmaceutical Industry Perspective**
**Increasing minority participation in all clinical trials is good business**
**FDA Perspective**
**Mandate, mandate, mandate**