|Dose Finding in Drug Development---Study Design Considerations --CANCELLED
Monday, November 13, 2006
4:10 p.m.-5:00 p.m.
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
these doses. 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.