A new peer-reviewed article co-authored by several Cytel scientists re-examines the way in which adaptive trials are designed and implemented within the oncology space. The wide ranging paper spans numerous topics including data considerations, statistical considerations, the commercial and scientific value of flexibility in adaptive designs, and also a “Holistic Approach” to program development, wherein development plans are not created study by study, but across phases.
One of the paper’s observations is the pivotal role that statisticians can play in every phase of drug development, and the need to make quantitative strategy feature more prominently in trial design. The author’s observe, “…it is difficult to know when statistical expertise is needed, and to know what is unknown or unaccounted for. If a statistician is unaware that a trial faces a particular issue, they cannot suggest a solution…”
To learn about the Holistic Approach to trial design, how to avoid design phase by phase, and other new methods to streamline oncology drug development, click the link below to download a complimentary paper.