Description :

The randomized phase ii trial is a well known platform for testing the efficacy of novel agents in oncology with the potential of minimizing some of the pitfalls inherent in the single arm phase ii design 7 such studies fall into three main groups including randomized selection design pick the winner in which the best of two or more . Ratain mj sargent dj optimising the design of phase ii oncology trials the importance of randomization european journal of cancer 2008 to appear simon r thall pf ellenberg ss new designs for the selection of treatments to be tested in randomized clinical trials stat med 1994 13 5 7417 429. The optimal design of phase ii studies continues to be the subject of vigorous debate especially studies of newer molecularly targeted agents the observations that many new therapeutics fail in definitive phase iii studies coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials further emphasize the critical importance of . Drug development in oncology is a fast evolving field with numerous challenges 1 more than 1000 antineoplastic agents anas were under investigation in 2018 2 oncology had the highest overall attrition rate for us food and drug administration fda approval from phase i 95 between 2006 and 2015 phase ii 92 and phase iii 67 trials 34 the community aims to limit the recruitment . The 2018 new drugs in oncology pre annual meeting seminar focuses on the theoretical and practical aspects of both recently approved drugs and those on their way to approval topics covered will include mechanisms of action administration toxicity and side effect management and use in the clinic all pre annual meeting seminars are ticketed sessions and are not included in 2018 annual