The outline of reports for comparative efficacy trials (Phase III) is similar to that for safety and efficacy trials. There are many additional issues, however, to consider. For example, the reporting of treatment assignment (randomization) and masking procedures is necessary to assure readers about the internal validity of the trial. This is important because readers want to know how this was implemented. This is a mechanism that reviewers will use to assess the validity of the study.
The motivation and assumptions for the target sample size should be included, especially in a situation where the primary results are “negative” findings. The impact of various prognostic variables should be addressed with appropriate statistical analyses to demonstrate that treatment effects are not due entirely to them. Although the intent-to-treat principle should be followed in randomized trials, it is helpful to report on the results of various exploratory analyses as well.
Since the methods have direct implications on the validity of the results, top-line journals require thorough descriptions. They also expect supplemental reports. When the article is available online, there can be links to more detailed descriptions, figures, graphs, and tables.
- The CONSORT (Consolidated Standards of Reporting Trials) Group) updated its guidelines for the reporting of clinical trials, which appeared in multiple journals and is available online: Examine the CONSORT checklist and Flow Diagram in the CONSORT statement. These standards have been adopted by major medical journals.
- Schulz, K, D. Altman, D. Moher and for the CONSORT Group. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trial. Ann Intern Med June 1, 2010 152:726-732
- There are several extensions of the original CONSORT statement which can also be examined at the CONSORT website focusing on reporting patient safety. equivalence and non-inferiority trials, cluster trials, and other topics.
- Ioannidis JPA, Evans SJW, Getzsche PC, O’Neill RT, Altman DG, Schultz K, Moher D for the Consort Group. Better reporting of harms in randomized trials: An extension of the CONSORT statement. Annals of Internal Medicine 2004; 141:781-788.
- Piaggio, G., Elbourne, D., Altman, D., Pocock, S., Evans, S. for the CONSORT Group. Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT statement. JAMA 2006; 295: 1152-1160.
Conflict of Interest Section
ExampleIn the VALIANT trial (NEJM 2003, in Wk 5 course material) the authors state
- “Supported by a grant from Novartis Pharmaceuticals.” and
- that some of them also received financial payments from Novartis for serving as consultants, and some of them also have stock equity in Novartis. Anyone who reads the article should attempt to examine the statements about financial support and conflicts, in order to judge whether the article may present a biased viewpoint.