SPECIAL POPULATIONS IN CLINICAL TRIALS

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SPECIAL POPULATIONS IN CLINICAL TRIALS

• OBSERVATIONS OF A CONSUMER/PATIENT ADVOCATE
• IN THE ORGANIZATION AND EXECUTION
• OF
• SPECIAL POPULATION CLINICAL TRIALS
• AND
• RECCOMENDATIONS
• TO
• DEVELOPING SCIENTISTS
• Westley Sholes, MPA

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POINTS TO CONSIDER
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SPECIAL POPULATIONS IN CLINICAL TRIALS

• SPECIAL POPULATIONS ARE DEFINED IN SEVERAL
  WAYS
• RACE ETHNICITY
• AGE
• GENDER
• INCOME
• GEOGRAPHY
• SEXUAL ORIENTATION
• LANGUAGE

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SPECIAL POPULATIONS IN CLINICAL TRIALS

• EACH GROUP MAY HAVE GROUP ATTITUDES AND/OR
  FEARS.
• AN INDIVIDUAL MAY BE IN MORE THAN ONE GROUP
  .
• RECRUITMENT AND RETENTION MAY PRESENT
  SPECIAL CHALLENGES, I.E MINORITIES

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SPECIAL POPULATIONS IN CLINICAL TRIALS

• TEN COMMON IMPEDIMENTS
• TO
• RECRUITING AND RETAINING MINORITIES
• 1 Lack of understanding of Minorities'
  Knowledge, Attitudes and Practices regarding
  cancer.
• 2 Lack of protocols specific for cancers
  most often seem in minority populations or
  geographical area

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SPECIAL POPULATIONS IN CLINICAL TRIALS
1 Lack of understanding of
Minorities' Knowledge, Attitudes and
Practices regarding cancer. 2 Lack of
protocols specific for cancers most often
seem in minority populations or
geographical area.
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SPECIAL POPULATIONS IN CLINICAL TRIALS

• 3 Different tumor incidence in minority groups
  compared to whites.
• 4 Treatment protocols not available at
  patient's preferred treatment site- (HMO, PPO,
  Non Medical Center site etc.)

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SPECIAL POPULATIONS IN CLINICAL TRIALS

• 5 Financial constraints and Requirement of
  costly diagnostic procedures at specific times
  during course of treatment.
• 6 Time consuming for patients, who can often
  not afford time-off work or time away from
  home and children.

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SPECIAL POPULATIONS IN CLINICAL TRIALS

• 7 Lack of bilingual providers and use of
  translators does not promote adequate
  communication between patients/families
• and providers.
• 8 Concept of "guinea pig" still prevalent.

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SPECIAL POPULATIONS IN CLINICAL TRIALS

• 9 Lack of awareness of existing protocols by
  physicians and by the community.
• 10 Time consuming for physicians and staff to
  explain and translate protocols and consent
  forms for patients and/or family member (s).

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SPECIAL POPULATIONS IN CLINICAL TRIALS

• RECOMMENDATIONS
• ?DEVELOP MAINTAIN AN AWARENESS OF THE SPECIAL
  SOMETIMES NON-SCIENTIFIC ASPECTS OF THE
  POPULATIONS OF INTEREST.
• ? MAINTAIN AWARENESS OF THE DIFFICULT TASK OF
  BALANCING
• ADVANCEMENT OF SCIENCE
• PERSONAL ASPIRATIONS
• PATIENT BENEFIT