%0 Journal Article %1 Chi2008 %A Chi, Yunchan %A Chen, Chia-Min %D 2008 %J Statistics in medicine %K AntineoplasticAgents AntineoplasticAgents:adverseeffects AntineoplasticAgents:therapeuticuse Biometry Biometry:methods ClinicalTrials DrugDiscovery DrugDiscovery:statistics&numericaldata Etoposide Etoposide:adverseeffects Etoposide:therapeuticuse Humans Kaposi Kaposi:drugtherapy Lymphoma Mantle-Cell Mantle-Cell:drugtherapy Models PhaseIIasTopic PhaseIIasTopic:statistics&numericaldata Sarcoma Statistical StochasticProcesses TreatmentOutcome %N 29 %P 6175-89 %R 10.1002/sim.3424 %T Curtailed two-stage designs in Phase II clinical trials. %U http://www.ncbi.nlm.nih.gov/pubmed/18816510 %V 27 %X When the accrual rate is low and the treatment period is long, a long observational period is required before information concerning the primary end point, such as binary response, becomes available in the study. Simon's two-stage designs are often employed in Phase II clinical trials to avoid giving patient an ineffective drug. Thus, if the new drug is ineffective then this design would certainly accelerate the process of drug discovery and development. However, for a promising new drug this design may still require a long observational period. Therefore, when drug safety is not a primary concern, this paper proposes curtailed two-stage designs to shorten the drug development process as soon as the treatment either shows lack of efficacy or is very effective. The proposed design is superior to Simon's two-stage designs in terms of savings in expected sample size and is much easier to implement in practice than stochastically curtailed Simon's designs. %@ 1097-0258

@article{Chi2008, abstract = {When the accrual rate is low and the treatment period is long, a long observational period is required before information concerning the primary end point, such as binary response, becomes available in the study. Simon's two-stage designs are often employed in Phase II clinical trials to avoid giving patient an ineffective drug. Thus, if the new drug is ineffective then this design would certainly accelerate the process of drug discovery and development. However, for a promising new drug this design may still require a long observational period. Therefore, when drug safety is not a primary concern, this paper proposes curtailed two-stage designs to shorten the drug development process as soon as the treatment either shows lack of efficacy or is very effective. The proposed design is superior to Simon's two-stage designs in terms of savings in expected sample size and is much easier to implement in practice than stochastically curtailed Simon's designs.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Chi, Yunchan and Chen, Chia-Min}, biburl = {https://www.bibsonomy.org/bibtex/2bbeef09d8247aa795d45e7e5c2054112/jepcastel}, city = {Department of Statistics, National Cheng-Kung University, Tainan, Taiwan.}, doi = {10.1002/sim.3424}, interhash = {b7fc91922d13a76cb78e0e5f8f72e28d}, intrahash = {bbeef09d8247aa795d45e7e5c2054112}, isbn = {1097-0258}, issn = {1097-0258}, journal = {Statistics in medicine}, keywords = {AntineoplasticAgents AntineoplasticAgents:adverseeffects AntineoplasticAgents:therapeuticuse Biometry Biometry:methods ClinicalTrials DrugDiscovery DrugDiscovery:statistics&numericaldata Etoposide Etoposide:adverseeffects Etoposide:therapeuticuse Humans Kaposi Kaposi:drugtherapy Lymphoma Mantle-Cell Mantle-Cell:drugtherapy Models PhaseIIasTopic PhaseIIasTopic:statistics&numericaldata Sarcoma Statistical StochasticProcesses TreatmentOutcome}, month = {12}, note = {5263<m:linebreak></m:linebreak>LR: 20090730; JID: 8215016; 0 (Antineoplastic Agents); 33419-42-0 (Etoposide); ppublish;<m:linebreak></m:linebreak>Fase II}, number = 29, pages = {6175-89}, pmid = {18816510}, timestamp = {2023-02-03T11:44:35.000+0100}, title = {Curtailed two-stage designs in Phase II clinical trials.}, url = {http://www.ncbi.nlm.nih.gov/pubmed/18816510}, volume = 27, year = 2008 }