Reporting clinical trials

Updated methods for reporting clinical trials.

The reporting of early clinical trials is in evolution. As new drugs that target molecules that are selectively altered in cancer cells become available, much more will be expected from early trials than was expected in the past. Our concept of phase I trials that only determine maximum tolerated dose and recommended phase II dose of a drug will be replaced by different endpoints. These will in...

Methodological Reporting of Randomized Clinical Trials

BACKGROUND: Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking cl...

Reporting Bayesian analyses of clinical trials.

Many clinicians wrongly interpret p-values as probabilities that treatment has an adverse effect and confidence intervals as probability intervals. Such inferences can be validly drawn from Bayesian analyses of trial results. These analyses use the data to update the prior (or pre-trial) beliefs to give posterior (or post-trial) beliefs about the magnitude of a treatment effect. However, for th...

Reporting of clinical trials in Gut: the CONSORT statement. Consolidated Standards of Reporting 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...