Dynamic allocation of participants to treatments in a clinical trial has been an alternative to randomization for nearly 35 years. Design-adaptive allocation is a particularly flexible kind of dynamic allocation. Every investigation of dynamic allocation methods has shown that they improve...

Charles Manski of Northwestern argues that the drug approval process should be more continuous, so that patients can have access to beneficial drugs earlier and at the same time there are incentives for longer term studies than the current system produces, which could limit problems like those...

This paper highlights the status of the Indian biopharmaceutical industry and also makes a comparison with the global scenario. It also discusses the current situation regarding patenting biopharmaceuticals in India. [GIDR WP no. 168].

This paper models how the evolving field of pharmacogenomics (PG), which is the science of using genomic markers to predict drug response, may impact drug development times, attrition rates, costs,and the future returns to research and development (R&D). While there still remains an abundance of...

Arguments are being made more frequently to incorporate economic evaluations and quality of life assessments into clinical trials. Using two randomised, multicentre trials of radiotherapy for cancer as an example, this paper outlines: (1) the importance of including such assessments; (2) the...

Who gains from more information on the quality of pharmaceutical drugs? Are there incentives for voluntary post-approval clinical trials among pharmaceutical companies? Contrary to popular belief, this paper shows that it is not in the consumer interest that clinical evidence establishing the...

Randomized allocation of treatments is a cornerstone of experimental design, but has drawbacks when a limited set of individuals are willing to be randomized, or the act of randomization undermines the success of the treatment. Choice-based experimental designs allow a subset of the participants...

strbee analyzes a two-group clinical trial with a survival outcome, in which some subjects may "crossover" to receive the treatment of the other arm. Adjustment for treatment crossover is done by a randomization-respecting method that preserves the intention-to-treat p-value. Copyright 2002 by...

Repeated measurements are often collected over time to evaluate treatment efficacy in clinical trials. Most of the statistical models of the repeated measurements have been focusing on their mean response as function of time. These models usually assume that the treatment has persistent effect...

It has long been recognized that covariate adjustment can increase precision in randomized experiments, even when it is not strictly necessary. Adjustment is often straightforward when a discrete covariate partitions the sample into a handful of strata, but becomes more involved with even a...