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The Research Registry - Answering the call to register every research study involving human participants.

Agha R, Rosin D - Ann Med Surg (Lond) (2015)

View Article: PubMed Central - PubMed

Affiliation: Balliol College, University of Oxford, UK.

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In a more recent study, Jones et al. assessed 585 clinical trials that had recruited at least 500 participants and were prospectively registered on ClinicalTrials.gov and completed by January 2009... Why is this important? In 2013, the DoH changed to state:“Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject … …Negative and inconclusive as well as positive results must be published or otherwise made publicly available …... Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. ” This move away from clinical trials to “every research study” has important ramifications... Further evidence of the gap is provided in an article written by those working at ClinicalTrials.gov itself titled: Registration of observational studies: Is it time? This adds to several other recent calls to register protocols for observational research... Indeed Chalmers et al. have written specifically on how to increase value and reduce waste when research priorities are set... One of their recommendations was that research funders and regulators should strengthen and develop sources of information about research that is in progress, ensure that they are used by researchers, insist on the publication of protocols at study inception, and encourage collaboration to reduce waste... We wish to address this by allowing retrospective registration for all those studies not prospectively registered prior to recruitment of the first participant and which have not yet been published in a journal... We have also recently been endorsed by the IDEAL Collaboration, an initiative to improve the quality of surgical research... Its Chair Professor Peter McCulloch commented: “We welcome this initiative which allows registration of studies and protocols at every stage of the innovation lifecycle. ” The ResearchRegistry.com is work in progress and will evolve with time to meet the needs of the community... We call on readers, authors, reviewers, editors and the scholarly community at large to encourage use of this service for the benefit of us all and future generations.

No MeSH data available.


Studies registered on Clinicaltrials.gov, by year and funding source (taken from Gill, 20129).
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fig1: Studies registered on Clinicaltrials.gov, by year and funding source (taken from Gill, 20129).

Mentions: Journal editors have been influential in raising awareness about these issues. In 2004, the International Committee of Medical Journal Editors (ICMJE) made registration of clinical trials a requirement for publication in their journals [8]. This led to a sharp increase in the number of trials being registered which did not occur when the US Federal Drug Administration (FDA) called for it in 2002 (see Fig. 1) [9]. In 2008, the Declaration of Helsinki (DoH) made registration of Clinical Trials mandatory and hence it became an ethical requirement in addition to a regulatory one.


The Research Registry - Answering the call to register every research study involving human participants.

Agha R, Rosin D - Ann Med Surg (Lond) (2015)

Studies registered on Clinicaltrials.gov, by year and funding source (taken from Gill, 20129).
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4388910&req=5

fig1: Studies registered on Clinicaltrials.gov, by year and funding source (taken from Gill, 20129).
Mentions: Journal editors have been influential in raising awareness about these issues. In 2004, the International Committee of Medical Journal Editors (ICMJE) made registration of clinical trials a requirement for publication in their journals [8]. This led to a sharp increase in the number of trials being registered which did not occur when the US Federal Drug Administration (FDA) called for it in 2002 (see Fig. 1) [9]. In 2008, the Declaration of Helsinki (DoH) made registration of Clinical Trials mandatory and hence it became an ethical requirement in addition to a regulatory one.

View Article: PubMed Central - PubMed

Affiliation: Balliol College, University of Oxford, UK.

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

In a more recent study, Jones et al. assessed 585 clinical trials that had recruited at least 500 participants and were prospectively registered on ClinicalTrials.gov and completed by January 2009... Why is this important? In 2013, the DoH changed to state:“Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject … …Negative and inconclusive as well as positive results must be published or otherwise made publicly available …... Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. ” This move away from clinical trials to “every research study” has important ramifications... Further evidence of the gap is provided in an article written by those working at ClinicalTrials.gov itself titled: Registration of observational studies: Is it time? This adds to several other recent calls to register protocols for observational research... Indeed Chalmers et al. have written specifically on how to increase value and reduce waste when research priorities are set... One of their recommendations was that research funders and regulators should strengthen and develop sources of information about research that is in progress, ensure that they are used by researchers, insist on the publication of protocols at study inception, and encourage collaboration to reduce waste... We wish to address this by allowing retrospective registration for all those studies not prospectively registered prior to recruitment of the first participant and which have not yet been published in a journal... We have also recently been endorsed by the IDEAL Collaboration, an initiative to improve the quality of surgical research... Its Chair Professor Peter McCulloch commented: “We welcome this initiative which allows registration of studies and protocols at every stage of the innovation lifecycle. ” The ResearchRegistry.com is work in progress and will evolve with time to meet the needs of the community... We call on readers, authors, reviewers, editors and the scholarly community at large to encourage use of this service for the benefit of us all and future generations.

No MeSH data available.