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Statistics and Statistical Careers in Clinical Trials

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Statistics and Statistical Careers in Clinical Trials Powered By Docstoc
					Statistics and Statistical Careers
         in Clinical Trials
              Joseph Massaro
         Department of Biostatistics
   Boston University School of Public Health
                jmm@bu.edu
                Clinical Trial
• Clinical trials: Trials to evaluate the
  effectiveness and safety of medications or
  medical devices by monitoring their effects on
  large groups of people (www.medterms.com).
Lipitor (Atorvastatin) Effect on MI/Death
       (from www.drugs.com/pro/lipitor.html)
      Example of a Clinical Trial Question on
          Advanced Placement Exam
• FDA will recommend a new cholesterol drug if there is
  sufficient evidence it reduces cholesterol >10 mg/dl
  more than placebo, on average, over 6 weeks. Let μE,
  μP = true mean 6-week cholesterol reduction (mg/dl)
  for the experimental and placebo, respectively.
      Example of a Clinical Trial Question on
          Advanced Placement Exam
• FDA will recommend a new cholesterol drug if there is
  sufficient evidence it reduces cholesterol >10 mg/dl
  more than placebo, on average, over 6 weeks. Let μE,
  μP = true mean 6-week cholesterol reduction (mg/dl)
  for the experimental and placebo, respectively.

  – A. What is the null and alternative hypothesis of interest?
      Example of a Clinical Trial Question on
          Advanced Placement Exam
• FDA will recommend a new cholesterol drug if there is
  sufficient evidence it reduces cholesterol >10 mg/dl
  more than placebo, on average, over 6 weeks. Let μE,
  μP = true mean 6-week cholesterol reduction (mg/dl)
  for the experimental and placebo, respectively.

  – A. What is the null and alternative hypothesis of interest?
     H0: μE - μP ≤ 10 vs. H1: μE - μP > 10
      Example of a Clinical Trial Question on
          Advanced Placement Exam
• FDA will recommend a new cholesterol drug if there is
  sufficient evidence it reduces cholesterol >10 mg/dl
  more than placebo, on average, over 6 weeks. Let μE,
  μP = true mean 6-week cholesterol reduction (mg/dl)
  for the experimental and placebo, respectively.

  – B. 200 people were in the clinical trial: 100 received
    experimental and 100 received control. The sponsor
    performed a paired t-test to test H0. Is this appropriate?
      Example of a Clinical Trial Question on
          Advanced Placement Exam
• FDA will recommend a new cholesterol drug if there is
  sufficient evidence it reduces cholesterol >10 mg/dl
  more than placebo, on average, over 6 weeks. Let μE,
  μP = true mean 6-week cholesterol reduction (mg/dl)
  for the experimental and placebo, respectively.

  – B. 200 people were in the clinical trial: 100 received
    experimental and 100 received control. The sponsor
    performed a paired t-test to test H0. Is this appropriate?
      No: the two groups are independent.
             Degrees and Careers
• To pursue a career in clinical trials, stat/biostat
  degrees to first consider are:
   – Bachelors (undergraduate)

   – Masters of Public Health (“concentration” in
     biostatistics)

   – Masters in Statistics/Biostatistics

   – Ph.D. in Statistics/Biostatistics
             Degrees and Careers
• Bachelors
  – Gets your “foot in door” – entry level jobs
  – To advance career as a clinical trials biostatistician,
    strongly consider graduate degree
  – Bachelors in stats/biostats not necessarily required
    to pursue graduate degree in stats/biostats
     • Mathematics
     • Biology
     • Need at least 2 semesters of Calculus and Linear Algebra
               Degrees and Careers
• Masters of Public Health (MPH)
   – MPH usually very applied curriculum (little statistical theory)
   – Again, gets your “foot in door” as clinical trial biostatistician
      • Probably can handle 50-75% of clinical trial analyses
   – To advance career as a clinical trial biostatistician, consider
     Masters or Ph.D. in statistics/biostatistics
   – Other clinical trial opportunities with MPH:
      • Require knowledge of statistics but not necessarily performing
        statistical analysis
          – Statistical Programmer
          – Data Manager
          – Trial Manager
           Degrees and Careers
• Masters in Statistics/Biostatistics
  – Applications and underlying theory
  – Often more than adequate to have a successful
    biostatistical career in clinical trials
     • Design clinical trials
     • Develop statistical plan for clinical trials
     • Carry out analysis
  – If “upper management” is a goal, consider Ph.D.
            Degrees and Careers
• Ph.D. in Statistics/Biostatistics
   – More applications/more advanced theory
   – Similar biostatistical opportunities as Master’s, but
     perhaps for more complex studies.
      • Also, present (and “defend”) designs and analysis
        results to regulatory agencies
   – Often required for upper
     management/supervisory positions
                      Intangibles
• Be a good “team” member – ability to work with
  others
• Ability/willingness to investigate and learn
• Starting out: willingness to do “entry level” tasks
   – EVERY task has an opportunity to learn
   – While in graduate school I performed data entry for
     two years
      • I learned in that time about how data is collected and
        managed for a clinical trial
   – Proofread clinical trial reports/manuscripts
   – Double-check computer output (quality control)
    Don’t Ignore Other Disciplines in
        Undergraduate Career
• E.g., Clinical trial statisticians need to be good
  writers (grammar, conciseness)
   – Manuscript writing for journals
   – Reports for FDA

				
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posted:11/7/2012
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