Naitee Ting

Boehringer-Ingelheim Pharmaceuticals Inc., Department of Biostatistics and Data Sciences

“Design of Dose-Response Clinical Trials”

Date: Thursday, September 21, 2017
Time: 2:45 p.m.
Location: 301 Biological Sciences

In the process of drug discovery and drug development, understanding the dose-response relationship is one of the most challenging tasks. It is also critical to identify the right range of doses in early stages of clinical development so that Phase III trials can be designed to confirm some doses within this dose range. Usually at the beginning of Phase II, there is not a lot of available information to help guiding the study design. At this stage, Phase II clinical studies are needed to establish proof of concept (PoC), to identify a set of potentially effective and safe doses, and to estimate dose-response relationships.

Challenges in designing these studies include: selection of the dose frequency and the dose range, choice of clinical endpoints or biomarkers, and use of control(s), among others. Consequences of bad Phase II study designs may lead to the delay of the entire clinical development program or the waste of R&D investment. Misleading results obtained from poor designs could cause a Phase III program to confirm a wrong set of doses, or to stop developing a potentially useful drug. Therefore, it is critical to consider an entire drug development plan, to make best use of all the available information, and to include all relevant experts in designing Phase II dose response clinical trials. This presentation discusses some of these considerations.

Upcoming Exams

STAT 1000 A03 Final
Friday, August 25 at 1:30 p.m.

STAT 2000 A01 Final
Friday, August 25 at 6:00 p.m.

Upcoming Seminar

Statistics seminar: Naitee Ting: “Design of Dose-Response Clinical Trials” — Thursday, September 21 at 2:45 p.m., 301 Biological Sciences.

Where are they now?

Keumhee Chough, M.Sc. (1985)

You Liang, Ph.D. (2015)