Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals.
PLoS Med
; 10(12): e1001566; discussion e1001566, 2013 Dec.
Article
em En
| MEDLINE
| ID: mdl-24311990
ABSTRACT
BACKGROUND:
The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration-approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals. METHODS ANDFINDINGS:
We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched PubMed for corresponding publications. Data were extracted independently from ClinicalTrials.gov and from the published articles for trials with results both posted and published. We assessed the time to first public posting or publishing of results and compared the completeness of results posted at ClinicalTrials.gov versus published in journal articles. Completeness was defined as the reporting of all key elements, according to three experts, for the flow of participants, efficacy results, adverse events, and serious adverse events (e.g., for adverse events, reporting of the number of adverse events per arm, without restriction to statistically significant differences between arms for all randomized patients or for those who received at least one treatment dose). From the 600 trials with results posted at ClinicalTrials.gov, we randomly sampled 50% (nâ=â297) had no corresponding published article. For trials with both posted and published results (nâ=â202), the median time between primary completion date and first results publicly posted was 19 mo (first quartileâ=â14, third quartileâ=â30 mo), and the median time between primary completion date and journal publication was 21 mo (first quartileâ=â14, third quartileâ=â28 mo). Reporting was significantly more complete at ClinicalTrials.gov than in the published article for the flow of participants (64% versus 48% of trials, p<0.001), efficacy results (79% versus 69%, pâ=â0.02), adverse events (73% versus 45%, p<0.001), and serious adverse events (99% versus 63%, p<0.001). The main study limitation was that we considered only the publication describing the results for the primary outcomes.CONCLUSIONS:
Our results highlight the need to search ClinicalTrials.gov for both unpublished and published trials. Trial results, especially serious adverse events, are more completely reported at ClinicalTrials.gov than in the published article.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Editoração
/
Ensaios Clínicos como Assunto
Tipo de estudo:
Clinical_trials
Limite:
Humans
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article