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Statistics and Statistical Careers in Clinical Trials

Statistics and Statistical Careers in Clinical Trials. Joseph Massaro Department of Biostatistics Boston University School of Public Health jmm@bu.edu. Clinical Trial.

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Statistics and Statistical Careers in Clinical Trials

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  1. Statistics and Statistical Careers in Clinical Trials Joseph Massaro Department of Biostatistics Boston University School of Public Health jmm@bu.edu

  2. 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).

  3. Lipitor (Atorvastatin) Effect on MI/Death(from www.drugs.com/pro/lipitor.html)

  4. 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.

  5. 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?

  6. 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

  7. 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?

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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)

  15. 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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