𝔖 Bobbio Scriptorium
✦   LIBER   ✦

The quest for unbiased research: Randomized clinical trials and the CONSORT reporting guidelines

✍ Scribed by Dr Kenneth F. Schulz


Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
487 KB
Volume
41
Category
Article
ISSN
0364-5134

No coin nor oath required. For personal study only.

✦ Synopsis


Abstract

The large and increasing number of randomized clinical trials in all of medicine has prompted the introduction of guidelines that are intended to improve the quality of the research and of the published papers derived from such investigations. These guidelines for reporting clinical trials, the Consolidated Standards of Reporting Trials (the CONSORT statement) were set forth by a group of journal editors, statisticians, biomedical investigators, and editors. The CONSORT statement has been published in several major medical journals and is likely to have a major impact on editorial policies as well as the design of such investigations. I have invited Dr Kenneth F. Schulz of the Centers for Disease Control and Prevention, a leading investigator in the evaluation of clinical trials and a participant in the design of the CONSORT guidelines, to prepare this brief summary for the Annals. The CONSORT statement is expected to have a substantial effect on the peer review of clinical trials, and it promises to elevate the quality of such investigations. Future submissions to the Annals will be evaluated in the context of these guidelines.


πŸ“œ SIMILAR VOLUMES


Guidelines for assessing the performance
✍ Alan Phillips πŸ“‚ Article πŸ“… 2000 πŸ› John Wiley and Sons 🌐 English βš– 76 KB πŸ‘ 2 views

## This paper seeks to help statisticians in the pharmaceutical industry to assess their own competency and to encourage continued development. The approach adopted is to clarify the role of statisticians in Phase II/III clinical research. Objective criteria for assessing performance in terms of qua

A comparison of the randomized play-the-
✍ D. S. Coad; William F. Rosenberger πŸ“‚ Article πŸ“… 1999 πŸ› John Wiley and Sons 🌐 English βš– 91 KB πŸ‘ 2 views

We consider a clinical trial model comparing an experimental treatment with a control treatment when the responses are binary. For fixed significance level and power, we compare the expected number of treatment failures for two designsthe randomized play-the-winner rule and the triangular test. The

The combination of cisplatin, doxorubici
✍ Vincenzo De Lisi; Giorgio Cocconi; Francesco Angelini; Francesco Cavicchi; Franc πŸ“‚ Article πŸ“… 1996 πŸ› John Wiley and Sons 🌐 English βš– 482 KB πŸ‘ 2 views

## BACKGROUND. In a randomized Phase I1 study, the authors evaluated the activity and toxicity of the new cisplatin, doxorubicin, and mitomycin C (PAM) comhination, that includes cisplatin (P) instead of 5-fluorouracil as in the 5-fluorouracil, doxorubicin, and mitomycin C (FAM) Combination, in pat

Practical issues in quality of life asse
✍ JΓΌrg Bernhard; Heidi Gusset; Christoph HΓΌrny πŸ“‚ Article πŸ“… 1998 πŸ› John Wiley and Sons 🌐 English βš– 130 KB πŸ‘ 2 views

Quality of life (QOL) assessment has become an integrated part in some advanced disease trials and to a lesser extent in early disease trials conducted by the Swiss Group for Clinical Cancer Research (SAKK). In general, the concept of QOL endpoints and the additional work of collecting these data is