Methods and Biostatistics in Oncology by Raphael L. C. Araújo & Rachel P. Riechelmann

Author:Raphael L. C. Araújo & Rachel P. Riechelmann
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

Conclusions

An ideal phase I trial would be efficiently performed with the minimum number of patients being exposed to sub-therapeutic or toxic doses, leading to accurate determination of an RP2D, a toxicity profile for an agent and a decision about its ongoing development. Sadly, the designs for such trials remain elusive, with clinical trials in the real world being beset by compromises, particularly given the tension between the need for rapid drug development due to cost and the need for generating optimal data and dose decisions. There has been an exponential increase in the number of oncological agents being trialled, but the approval rate for oncology drugs remains poor and the time for drug development is prolonged compared with the time for the development of drugs with non-oncological indications [72, 73]. Continuing to run the same style of clinical trials as we have in the past will not lead to improvements in the efficiency and cost-effectiveness of drug development. However, there is room for optimism, given the increasing prevalence of new technologies—such as high-throughput screening techniques and computational-based network platforms—to drive rational combinations, as well as adaptive trial designs to meet these challenges.

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