BDH

1
BDH
Clinical Research Services, Inc.
Basil D. Halliday, M.Sc. President CEO

Discovering Tomorrows Healthcare Solutions Today
2

• INCREASING MINORITY PARTICIPATION IN CLINICAL
  TRIALS CHALLENGES AND POTENTIAL SOLUTIONS

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
• Tarnished industry image in the media

5
The Current Picture
FDA 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 fixed-dose drug regimens
  are in need of revision due to inter-patient
  interracial variability in PK PD

7
(No Transcript)
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?.............

9
Well Known Differences

• Research in the last 35 years has uncovered
  significant differences among racial and ethnic
  groups
• African American hypertensives respond better to
  monotherapy with diuretics
• African American hypertensives less responsive to
  monotherapy with ACE inhibitors
• African Americans show higher blood levels,
  faster therapeutic response, and greater toxicity
  for a given dose of a tricyclic antidepressant
• African Americans respond better to BiDil

10
Clinical Trials

• Minority participation and representation
• Increasingly important
• Difficult to achieve
• Can cause costly delays in clinical trials
  execution and drug approval process
• Each day delay in recruitment and approval costs
  1M per day (TIME IS MONEY)

11
Potential Solutions
Industry

• Clinical trials specifically for priority
  populations
• Increased use of minority physicians as
  investigators
• Invest in long term relationships and
  partnerships with minority communities (dont
  just give )
• Educate, educate, educate about the clinical
  research process, eg. pharmaceutical industry not
  involved in Tuskegee, DTC education

12

• in the past, men of other races have for the
  large part, interpreted our diseases, often
  tinctured with inborn prejudices.
• Charles Garvin, M.D., member, Editorial board,
  Journal of the National Medical Association,
  circa 1930s

13
Potential Solutions
Minority Perspective

• Educate, educate, educate about the importance
  and value-added benefits of clinical trials
  participation (eg. free, state-of-the-art
  medical care
• Create a pipeline of future physicians, minority
  scientists/researchers
• Become informed and then consent to
  participate

14
Potential Solutions
FDA Perspective

• Legislative mandate (potential magic bullet)
• Denial of marketing approval without
  representative sample
• Specific guidance on degree of representation
  required
• Mandate, mandate, mandate

15
Take Home Messages

• Need to increase minority participation
• Ethically appropriate
• Scientifically sound
• Win-win-win situation for healthcare, patients
  and the pharmaceutical industry

16
Minority Participation in Clinical Trials

• Impact will be felt from Wall Street to Main
  Street, suburbs and urban centers
• Greater access to untapped or previously
  problematic markets
• Increased Rx writing by MDs and high volume due
  to increased trust with patients
• Build relationships with ethnic minority
  communities

17
Making a Difference Current Initiatives by BDH

• CRISP
• BDH generated Investigator Initiated Clinical
  Trials
• HBCU lecture Series on Clinical Research
• Minority Community outreach and education through
  IRBs
• NIH grant reviewers education on minority
  inclusion in clinical trials as part of the grant
  review and funding process
• CBC legislative mandate for representative
  sample

18
(No Transcript)