- Continuing education on recent advances in biostatistics
|Talks focused on translating recent advances in biostatistics into practice.||Biostatistics Seminar Series|
During the 2015-16 academic year, the Harvard Catalyst Biostatistics Program will present a series of talks based on recent advances in biostatistics, but with a focus on translation of those ideas to biostatistical practice. Speakers will provide detailed examples of the application of methods, often including discussion of software, code, and worked examples.
If you missed our December course on Methods of Analysis of Genetic Studies with Dr. Liming Liang, you can now view it on our Past Seminars page.
Cyrus Mehta, PhD; Charles Liu, PhD; Yannis Jemiai, PhD; Scott Evans, PhD
April 4, 11, 25, & May 2, 2016
April 4: 8:00am-12:00pm, DFCI (450 Brookline Ave.), SM 308/309
April 11: 8:00am-12:00pm, Kresge G1/Snyder Auditorium (677 Huntington Avenue)
April 25: 8:00am-12:00pm, Kresge G1/Snyder Auditorium (677 Huntington Avenue)
May 2: 8:00am-12:00pm, Kresge G1/Snyder Auditorium (677 Huntington Avenue)
Reservations are requested.
This four-part workshop will introduce participants to modern methods for designing Phase I, II, and III clinical trials. The lecture material will be followed by hands-on exercises with the East® software to consolidate understanding of the material. The focus is on understanding the concepts rather than the technical and mathematical details. Participants are required to bring laptops to Sessions 2-4 and will receive an East® license through 2016.
April 4, Session 1 (8:30am-11:00am): Clinical Trials: Today and Tomorrow
Lecture: We will discuss a few challenging issues in clinical trials today and a few issues that will be of increased importance in the future. Topics include noninferiority, pragmatism, and benefit:risk evaluation using the desirability of outcome ranking (DOOR).
Slides from Dr. Evans's presentation: [PDF] and [PDF]
April 11, Session 2 (8:00am-noon): Dose Escalation for Phase I Oncology Trials
Lecture: Limitations of 3+3 method; Introduction to Bayesian model-based methods such as Continual Reassessment Method (CRM), modified Toxicity Probability Interval (mTPI) method, Bayesian Logistic Regression Model (BLRM), and Product of Independent beta Probabilities Escalation (PIPE) method.
Software Exercises: Evaluate operating characteristics of various methods under different dose-toxicity assumptions to inform the best choice of design parameters.
Slides from Dr. Lui's presentation [PDF]
April 25, Session 3 (8:00am-noon): Group Sequential Designs for Phase III Trials
Lecture: Early efficacy stopping; alpha spending; futility boundaries; p-values and confidence intervals adjusted for early stopping; extensions to multiple treatment arms.
Software Exercises: Design and monitoring of the CAPTURE trial for percutaneous coronary intervention
May 2, Session 4 (8:00am-noon): Adaptive Designs for Phase II and Phase III Trials
Lecture: Sample size re-estimation in group sequential designs; integrated Phase II/III designs with dose selection and sample size re-estimation at the end of Phase I.
Software Exercises: Design of the Valor trial for acute myeloid leukemia; design of the Advent trial for HIV induced diarrhea.
Jacqueline Starr, PhD, MS, MPH, and Kyu Ha Lee, PhD
April 27, 2016
12:30pm-1:30pm, HSPH, Building 2, Room 426
Please join us for this meeting of the Harvard Catalyst Biostatistics Journal Club. The leaders of this meeting will be Dr. Jacqueline Starr, PhD, MS, MPH, Associate Member and Director of the Epidemiology and Biostatistics Course at The Forsyth Institute, and Kyu Ha Lee, PhD, Assistant Research Investigator at The Forsyth Institute. Please contact Megan Scott for call-in information.
Mark Vangel, PhD
Assistant Professor of Radiology, HMS; Biomedical Imaging Core, MGH
June 22, 2016
12:30pm-1:30pm, MGH, 50 Staniford Street, Suite 560
Please join us for this meeting of the Harvard Catalyst Biostatistics Journal Club. The leader of this meeting will be Dr. Mark Vangel, Assistant Professor of Radiology at Harvard Medical School. Please contact Megan Scott for call-in information.
See also our past biostatistics seminars.