Effectiveness of adaptive designs for phase II cancer trials.

摘要: Abstract Background Evaluation of new therapies for cancer has suffered a paradigm shift in the last years. The use innovative and more efficient designs is priority scientific community; nevertheless, this kind design not yet wide spread. Purpose In paper will examine effectiveness adaptive compared with traditional phase II clinical trials. Methods We reviewed group abstracts records between 1980 2008 extracted data regarding statistical design, year publication, evaluated product, localization, sample size results Results Nine hundred eighty-nine trials were identified from them 333 19 included review. Two papers located 16 most frequent Standard up down designs, continual reassessment methods its variation Bayesian approaches. More than 80% studies different schemes chemotherapy. Adaptive only drugs any treatment combination often localizations both lung, haematology malignancies, colon cancers. Conclusions are point view but they widely used because complex computationally intensive needed, substantial effort planning lack regulatory guidance.