Prioritisation and design of clinical trials

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...

Using economic modelling to contribute to the prioritisation and design and clinical trials: ready for prime time

It is now generally recognised that health systems internationally have resource constraints and need to set priorities in selecting the interventions they fund. Hence considerations of value for money are central in health policy worldwide. Cost-effectiveness analysis is a formal assessment of value, and is central to how many health care systems make resource allocation decisions. The purpose...

Clinical Trials Study Design

Observational Studies: Observational studies provide a mechanism for clarifying the epidemiology and risk factors/exposures that place populations at risk for disease. Observational studies assist in identifying clinical outcomes that might aid in predicting future disease. This type of study allows researchers to draw conclusions about responses to variables; they allow for associations but no...

ST4241: Design and Analysis of 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...