Shortly after receiving his doctorate in 1978, Ed joined the Biostatistics Research Branch (BRB), which was part of the National Heart Lung and Blood Institute, at the National Institutes of Health. NIH was one of the early proponents of rigorous trial design, and was a hotbed of activity both in the sponsorship and research methodology of large trials.
At the NIH, Ed was involved in the design, implementation, and day-to-day activities of many large clinical trials. In response to the design complexities of the SHEP trial, initiated in 1984, Ed developed the now well-known Markov model approach for calculating sample size and power for clinical trials (1986). He soon adapted it for the log rank statistic (1988). Over the next 20 years he continued to develop and refine his Markov approach which serves as the basis of STOPP® .
At the time Ed joined the NIH, interim and group sequential analyses were becoming an important issue in clinical trials. Lan and DeMets (1983), also at the BRB, published their seminal article that introduced the spending function. Ed was still at the BRB when he extended his Markov approach to group sequential trials, as part of the design of the Women's Health Initiative, one of the largest and most important clinical trials of the NIH.
In 1992, Ed joined the Pharmaceutical Industry. Over the next ten years he held positions of increasing responsibility, eventually leading a group of 70 statisticians, programmers and data managers as Senior Director of Biostatistics and Data Management. Ed took a central role in the design, development and approval process of many drugs in many therapeutic areas, and interacted extensively with the FDA. Because of his unique background, Ed continued to play a pivotal role in the design and analysis of large trials, also in a variety of therapeutic areas.
Ed began his consulting business, BiostatHaven Inc., in 2002. This position allowed Ed to focus on his statistical and clinical trial savvy, and pursue his research interests. In 2005, BiostatHaven Inc., with Ed as Principle Investigator, was awarded a grant from the NIH to develop statistical software that would make widely available the methods he had developed for the design of clinical trials, especially with interim analyses. STOPP® software is a result of that endeavor. The insights Ed gained from over a decade as a researcher and applied trial statistician in the nation’s premiere health organization, as member of many teams during the decade he worked in the pharmaceutical industry, and as an expert consultant provided a unique perspective as he lead the development of STOPP.
Ed has had extensive involvement in DSMBs, while at the NIH, within the Pharmaceutical Industry, and as a consultant. In 2007, Ed was elected a fellow of the American Statistical Association.
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order STOPP® online by visiting STOPPsmart.comSTOPP® software was made possible by SBIR Grant Number R44CA101617 from the National Cancer Institute of the National Institutes of Health.