Need for confidence intervals in reporting clinical trials

Confidence Intervals in Analysis and Reporting of Clinical Trials

Regulatory agencies around the world have recommended reporting confidence intervals for treatment differences along with the results of significance tests. SAS provides easy and convenient ways to produce confidence intervals using procedures such as PROC GLM and PROC UNIVARIATE in conjunction with ODS (output delivery system). In this paper, I will discuss the relationship between significanc...

Safety reporting in randomized clinical trials - a need for improvement.

The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and adequate sample size and power calculati...

Standards of reporting Ayurvedic clinical trials — Is there a need?

Reported lack of efficacy of Ayurvedic treatments in clinical trials is often not due to inefficacy of the treatment itself, but arises from inadequacies of trial design. This paper argues that trials of Ayurvedic interventions should exclusively use its multi-component, individualized and inherently holistic approach, and that general guidelines for rigorously reporting such clinical trials sh...

Repeated confidence intervals for adaptive group sequential trials.

This paper proposes a method for computing conservative confidence intervals for a group sequential test in which an adaptive design change is made one or more times over the course of the trial. The key idea, due to Müller and Schäfer (Biometrics 2001; 57:886-891), is that by preserving the null conditional rejection probability of the remainder of the trial at the time of each adaptive change...

Patient confidence in clinical trials.