Lawrence Rubinstein, Ph.D.

Biography

Lawrence Rubinstein received a Ph.D. in mathematical statistics from the Univ. of Maryland (1978). He has been in the Biometrics Research Program, NCI since 1985. He has published in a variety of areas relating to both clinical and pre-clinical studies. He helped to define methods for determining the required sample size in phase 3 studies. He has been involved in developing new designs for phase 0 trials and phase 1 trials and defining appropriate designs for phase 2 trials. He was involved with establishing and updating the RECIST response criteria and participated in a 10-year review of phase 1 trial risks and benefits. He participated in the development of the in-vitro assay analysis tools used for the NCI human tumor cell line screen and was responsible for statistical analyses that determined the degree of correlation between in-vitro and in-vivo results, for that screen, and phase 2 clinical results. His current responsibilities involve primary statistical review and advising capacities on NCI/CTEP clinical studies, helping to design and analyze NCI/DCTD pre-clinical and early clinical studies, as well as service on data monitoring committees, national clinical trials steering committees, and statistical liaison responsibilities with national cancer clinical trials organizations. He is on the statistical editorial board of the Journal of the National Cancer Institute and the editorial board of Clinical Cancer Research.

Research Interests

Design, monitoring and analysis of clinical trials; pre-clinical drug screening and developmental clinical trials; gynecologic, gastrointestinal, and central nervous system cancer.