Analyzing the same data in two ways: a demonstration model to illustrate the reporting and misreporting of clinical trials.
- 1 July 1989
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 7 (7) , 969-978
- https://doi.org/10.1200/jco.1989.7.7.969
Abstract
The methods used to analyze and interpret clinical trials of chemotherapy may have a major impact on the conclusions that are drawn in papers reporting them. To illustrate this problem, we constructed a hypothetical clinical trial in which patients with metastatic cancer were treated with chemotherapy. The following two articles provide reports of this trial, analyzed by methods that we would interpret as being of low and high quality, respectively. In the present report, we describe briefly the methodological differences that led to the opposite conclusions based on this single set of data. The errors of reporting and omissions of the first article (A) are similar to those that have been extracted from recent issues of the Journal of Clinical Oncology and other leading cancer journals, although they have not all appeared within a single report. This demonstration model illustrates problems in the reporting of clinical trials and suggests guidelines for improved reporting.This publication has 7 references indexed in Scilit:
- The Thrombogenic Effect of Anticancer Drug Therapy in Women with Stage II Breast CancerNew England Journal of Medicine, 1988
- Criteria of tumor response used in clinical trials of chemotherapy.Journal of Clinical Oncology, 1985
- Influence of measurement error on assessment of response to anticancer chemotherapy: proposal for new criteria of tumor response.Journal of Clinical Oncology, 1984
- Analysis of survival by tumor response.Journal of Clinical Oncology, 1983
- On the receiving end—II. Linear analogue self-assessment (LASA) in evaluation of aspects of the quality of life of cancer patients receiving therapyEuropean Journal of Cancer and Clinical Oncology, 1983
- Toxicity and response criteria of the Eastern Cooperative Oncology GroupAmerican Journal of Clinical Oncology, 1982
- The effect of measuring error on the results of therapeutic trials in advanced cancerCancer, 1976