J Am Med Inform Assoc - Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration.


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JECTIVE: To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)--namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed.MATERIALS AND METHODS: Observational study using computerized analysis of publicly available Medline article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010-2011, and data from the ClinicalTrials.gov (CTG) trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as the percentage of trials that registered the trial before enrolling the first participant within a 60-day grace period. We also examined timely registration rates by year of all phase II and higher interventional trials in CTG (registry-based sample).RESULTS: To determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) of trial journal articles included the trial ID. In 88.3% the trial-article link is stored within a structured Medline field. To evaluate timely registration, we analyzed trials referenced by 451 articles from the selected five journals. A total of 60% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began in 2008 were registered in a timely manner). In the registry-based sample, the timely registration rates ranged from 56% for trials registered in 2006 to 72% for trials registered in 2011.DISCUSSION: Adherence to URM requirements for registration and trial ID inclusion increases the utility of PubMed and links it in an important way to clinical trial repositories. This new integrated knowledge source can facilitate research prioritization, clinical guidelines creation, and precision medicine.CONCLUSIONS: The five selected journals adhere well to the policy of mandatory trial registration and also outperform the registry in adherence to timely registration. ICMJE's URM policy represents a unique international mandate that may be providing a powerful incentive for sponsors and investigators to document clinical trials and trial result publications and thus fulfill important obligations to trial participants and society.

Resumo Limpo

jectiv determin whether two specif criteria uniform requir manuscript urm creat intern committe medic journal editor icmjenam includ trial id registr within manuscript time registr trial followedmateri method observ studi use computer analysi public avail medlin articl data clinic trial registri data analyz purpos set five icmj found journal look trial articl publish journal data clinicaltrialsgov ctg trial registri measur adher trial id inclus polici percentag trial journal articl contain valid trial id within articl journalbas sampl adher time registr measur percentag trial regist trial enrol first particip within day grace period also examin time registr rate year phase ii higher intervent trial ctg registrybas sampleresult determin trial id inclus analyz clinic trial articl five journal total trial journal articl includ trial id trialarticl link store within structur medlin field evalu time registr analyz trial referenc articl select five journal total articl regist time manner improv trend trial initi later year eg trial began regist time manner registrybas sampl time registr rate rang trial regist trial regist discuss adher urm requir registr trial id inclus increas util pubm link import way clinic trial repositori new integr knowledg sourc can facilit research priorit clinic guidelin creation precis medicineconclus five select journal adher well polici mandatori trial registr also outperform registri adher time registr icmj urm polici repres uniqu intern mandat may provid power incent sponsor investig document clinic trial trial result public thus fulfil import oblig trial particip societi

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