Historical Information

1
(No Transcript)
2

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

3
The Current Picture
Industry Reality

• No data available is frequently cited
• We cant find em
• We get our drugs approved anyway, so why
  bother?
• The race debate in medicine, arent we all the
  same?
• Average is lt 5 in pivotal trials supporting drug
  safety and efficacy

4
The Current Picture
Minority Perspective

• I dont 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

5
The Current Picture
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
  gt of it but no mandate currently exists

6
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

7
BREAKING THE CYCLE
Increasing Participation and Community Trust
Overlook differential impact of diseases by
race/ gender/ethnicity
Poor trial Recruitment and retention
Health disparities
Perceived lack of caring affecting trust
Health system unresponsiveness
Source Office of AIDS Research, National
Institutes of Health
8
Patients Needs as Consumers of a Prescribed
Medication

• 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!!!

9
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

10
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
• Nitromeds 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

11
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