Related Experiment Videos
Design and analysis of group-randomized trials in cancer: a review of current practices
David M Murray1, Sherri L Pals, Jonathan L Blitstein
1Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA. dmurray@cph.osu.edu
Background:
Previous reviews have identified problems in the design and analysis of group-randomized trials in a number of areas. Similar problems may exist in cancer research, but there have been no comprehensive reviews.
Methods:
We searched Medline and PubMed for group-randomized trials focused on cancer prevention and control that were published between 2002 and 2006. We located and reviewed 75 articles to determine whether articles included evidence of taking group randomization into account in establishing the size of the trial, such as reporting the expected intraclass correlation, the group component of variance, or the variance inflation factor. We also examined the analytical approaches to determine their appropriateness.
Results:
Only 18 (24%) of the 75 articles documented appropriate methods for sample size calculations. Only 34 (45%) limited their reports to analyses judged to be appropriate. Fully 26 (34%) failed to report any analyses that were judged to be appropriate. The most commonly used inappropriate analysis was an analysis at the individual level that ignored the groups altogether. Nine articles (12%) did not provide sufficient information.
Conclusions:
Many investigators who use group-randomized trials in cancer research do not adequately attend to the special design and analytic challenges associated with these trials. Failure to do so can lead to reporting type I errors as real effects, mislead investigators and policy-makers, and slow progress toward control and prevention of cancer. A collaborative effort by investigators, statisticians, and others will be required to ensure that group-randomized trials are planned and analyzed using appropriate methods so that the scientific community can have confidence in the published results.
Related Concept Videos
Cancer Survival Analysis
Comparing the Survival Analysis of Two or More Groups
Hazard Ratio
For example, in a clinical trial evaluating a...
Randomized Experiments
Simple randomization
Simple...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Clinical Trials
There are four phases in a clinical trial. A phase one...