Update on FDAAA from ClinicalTrials.gov:
Basic Results Reporting at ClinicalTrials.gov and “Prior Publication”

(June 2008)

We have received questions concerning the posting of results at ClinicalTrials.gov (http://clinicaltrials.gov) in compliance with US Federal law and ”prior publication” decisions by journal editors.

As you may know, US Public Law 110-85, Title VIII, mandates the submission of “basic results” data for certain clinical trials of drugs, biologics, and devices, effective September 27, 2008. The law applies to trials that are not Phase 1 or small device feasibility studies, and that have at least one site in the US, regardless of who sponsors, finances, or conducts the trial. Certain other trials may also be covered by the law. In general, these summary results data must be submitted within 12 months of the completion of data collection for the primary outcome measure. The law also requires submission of results for pre-specified secondary outcome measures registered at ClinicalTrials.gov. Delays in submitting results may be granted for certain reasons, but not generally for journal submission. There could be significant penalties for failure to comply with this law.

These “basic results” include summary data tables of baseline characteristics, participant flow, outcomes, and adverse events. With the exception of several brief free-text fields for providing descriptions of the data, no narrative information is included (e.g., there is no discussion or conclusion section). There will be no patient level data.

The June 2007 ICMJE Update on Trial Registration[1] states that “the ICMJE will not consider results posted in the same primary clinical trials register in which the initial registration resides as previous publication if the results are presented in the form of a brief, structured (<500 words) abstract or table (p. 2).” The ICMJE recently reaffirmed this position at its 2008 annual meeting in Philadelphia.

Further, a January BMJ editorial[2] urges other journals to consider publication of results reported under the law to ClinicalTrials.gov for the following reasons:

Firstly, disclosure will be a legal requirement, so there is nothing editors can do about it if they still want to publish important trials of drugs and devices. Moreover, journals will continue to add value by publishing useful and readable trial reports that clinicians, the media, and patients can interpret and use. And, most importantly, the results disclosed for the FDA will not have been externally peer reviewed and will be preliminary. Peer review not only provides a stamp of quality assurance, it often leads to reanalysis of results.

Please feel free to contact me if you have any questions about this new feature of ClinicalTrials.gov.

Sincerely,
Deborah A. Zarin, M.D.
Director, ClinicalTrials.gov
Lister Hill National Center for Biomedical Communications,
National Library of Medicine
National Institutes of Health
dzarin@mail.nih.gov

1. ICMJE. Clinical trial registration: looking back and moving forward. Jun 2007. Accessed on September 22, 2008.

2. Groves T. Mandatory disclosure of trial results for drugs and devices. BMJ. Jan 2008 ;336:170.