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10.1200/JCO.2015.61.4362 http://scihub22266oqcxt.onion/10.1200/JCO.2015.61.4362 C4554752!4554752 !26261263     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=26261263 &cmd=llinks): Failed to open stream: HTTP request failed! 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Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials |pdf=|usr=}}{{26261263 }} gab.com Text Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials JO: J Clin Oncol http://www.kidney.de/pget.php?&tw=1&pmid=26261263 #FOAvip PURPOSE: Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. METHODS: We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. RESULTS: In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. CONCLUSION: Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. Twit Text FOAVip Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials ????J Clin Oncol http://www.kidney.de/pget.php?&tw=1&pmid=26261263 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26261263 #FOAvip English Wikipedia <ref>{{Cite pmid|26261263 }}</ref> Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials #MMPMID26261263 Halperin DM ; Lee JJ ; Dagohoy CG ; Yao JC J Clin Oncol 2015[Sep]; 33 (26 ): 2914-9 PMID26261263 show ga PURPOSE: Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. METHODS: We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. RESULTS: In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. CONCLUSION: Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. |*Clinical Trials, Phase II as Topic [MESH] |*Research Design [MESH] |Clinical Trials, Phase III as Topic [MESH] |Gastrointestinal Neoplasms/*drug therapy [MESH] |Humans [MESH]Rational Clinical Experiment: Assessing Prior Probability and Its Impa(epmc).pdf DeepDyve Pubget Overpricing