Publications & White Papers

Archive for March, 2009

Recruitment models in clinical trials

March 30th, 2009

Anisimov VV (2009). Recruitment models in clinical trials. Pharmaceutical Outsourcing, March/April 2009,1–10.

An update on discordance

March 26th, 2009

An update on discordance

Ohad Amit & Frank Mannino

An update on discordance

March 26th, 2009

An update on discordance

Ohad Amit & Frank Mannino

Recruitment Modeling and Predicting in Clinical Trials

March 15th, 2009

Anisimov VV (2009). Recruitment modeling and predicting in clinical trials, Pharmaceutical Outsourcing 10(1): 44–48.

Penalized designs of multi-response experiments

March 15th, 2009

Penalized designs of multi-response experiments

Valerii Fedorov and Yuehui Wu

An adaptive optimal design for the Emax model and its application in clinical trials

March 15th, 2009

An adaptive optimal design for the Emax model and its application in clinical trials

March 2nd, 2009

An adaptive optimal design for the Emax model and its application in clinical trials

Sergei Leonov and Sam Miller

Abstract: A project team working on a compound to treat Alzheimer’s disease is carrying out a first-time-in-human dose-escalation study in patients. The team wished to maximize the efficiency of the study by using doses targeted at maximizing information about the dose-response relationship within certain safety constraints. We have developed an adaptive optimal design tool to recommend doses when the response follows an Emax model, with functionality for pretrial simulation and in-stream analysis. We present the results of a simulation to investigate the operating characteristics of the applied algorithm.