Lawrence V Rubinstein
Affiliation: National Institutes of Health
- Therapeutic studiesL V Rubinstein
Biometric Research Branch, National Cancer Institute, Bethesda, Maryland, USA
Hematol Oncol Clin North Am 14:849-76, ix. 2000..This shared problem gives rise to statistical designs with basic similarities across the three trial types...
- Design issues of randomized phase II trials and a proposal for phase II screening trialsLawrence V Rubinstein
Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA
J Clin Oncol 23:7199-206. 2005....
- Randomized phase II designsLarry Rubinstein
National Cancer Institute, Bethesda, Maryland, USA
Clin Cancer Res 15:1883-90. 2009....
- The statistics of phase 0 trialsLarry V Rubinstein
Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
Stat Med 29:1072-6. 2010..The phase 0 trial promises to become an increasingly important tool for facilitating and speeding the development of new therapeutic agents, particularly in oncology...
- Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?Lori E Dodd
Division of Cancer Treatment and Diagnosis, Branches of Biometric Research, Investigational Drug, Cancer Investigations, and Diagnostic Imaging, National Cancer Institute, Rockville, MD 20892, USA
J Clin Oncol 26:3791-6. 2008..When such designs are not practical, BICR is not recommended as a general strategy for reducing bias. However, BICR may be useful as an auditing tool to assess the reliability of marginally positive results...
- Dose escalation trial designs based on a molecularly targeted endpointSally Hunsberger
Biometrics Research Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Stat Med 24:2171-81. 2005..A limited simulation study is performed and the designs are compared with respect to the dose level at the end of escalation and the number of patients treated on study...
- An information-intensive approach to the molecular pharmacology of cancerJ N Weinstein
Laboratory of Molecular Pharmacology LMP, Division of Basic Science, National Cancer Institute NCI, National Institutes of Health, Bethesda, MD 20892, USA
Science 275:343-9. 1997..It remains to be seen how effective this information-intensive strategy will be at generating new clinically active agents...
- Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trialsJ I Johnson
Developmental Therapeutics Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA
Br J Cancer 84:1424-31. 2001..0001). Structural parameters of the drugs analysed included compound molecular weight and hydrogen-bonding factors, both of which were found to be predictive of hollow fibre activity...