Adaptive Budgets in Clinical Trials

Adaptive Design for Clinical Trials

Adaptive design is a trial design that allows modifications to some aspects of the trial after its initiation without undermining the validity and integrity of the trial. Adaptive design makes it possible to discover and rectify inappropriate assumptions in trial designs, lower development costs and reduce the time to market. It has become very attractive to the pharmaceutical industries. In th...

Physician remuneration in industry-sponsored clinical trials: the case for standardized clinical trial budgets.

Practical Bayesian adaptive randomisation in clinical trials.

While randomisation is the established method for obtaining scientifically valid treatment comparisons in clinical trials, it sometimes is at odds with what physicians feel is good medical practice. If a physician favours one treatment over another based on personal experience or published data, it may be more appropriate ethically for that physician to use the favoured treatment, rather than e...

Using biomarkers prospectively in adaptive clinical trials

A standard approach to biomarker research is to retrospectively examine interactions between biomarkers and treatment effects. An alternative approach of examining such interactions prospectively has advantages. First, if the biomarker information is required for randomization then eliminates missing biomarker information. Another is that nonresponding biomarker subtypes in a multiarmed trial t...

Evaluation of Clinical Trials

In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...