Evidence map›Paper›PMID 26242226›Full record

ReviewEuropean journal of clinical pharmacology2015

The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.

Claudia Pansieri, Chiara Pandolfini, Maurizio Bonati

Abstract readHistorical ArticleReview
PubMed Publisher
In one paragraph

Review in European journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Claudia PansieriDepartment of Public Health, Laboratory for Mother and Child Health, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Via La Masa 19, 20156, Milan, Italy.
Chiara PandolfiniDepartment of Public Health, Laboratory for Mother and Child Health, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Via La Masa 19, 20156, Milan, Italy.
Maurizio BonatiDepartment of Public Health, Laboratory for Mother and Child Health, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Via La Masa 19, 20156, Milan, Italy. maurizio.bonati@marionegri.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeQuality of care is strongly influenced by evidence-based medicine, a large part of which is based on results obtained from clinical trials. If trials are conducted in secret, patient safety is at risk. Several mandates-legal, editorial, financial, and ethical-have tried to influence the disclosure of clinical trials, first by encouraging registration in publicly accessible registers and, second, by calling for the publication of results. Not all these initiatives have reached high rates of compliance, but the succession of national and international events over a few years gave an important boost to information disclosure. This article provides a chronicle of the succession of the events, from the historical calls to the recent EMA policy and WHO statement, and public consultations requested by the NIH, and the HHS, which will inevitably change the international panorama. The path of these new policies is moving towards more supervised clinical research. Individual scientific institutions can also contribute, at the local level, to such an ethical endeavor as is improving research transparency, by disclosing information on the trials coordinated by their own researchers.

resultsThe way is long and complex, but, if everyone contributes there could be a prompt, worldwide diffusion of the findings of clinical trials, and therefore a more possible evidenced-based medicine.

Indexed as

Clinical Trials as TopicDisclosureEthics, ResearchHistory, 20th CenturyHumansNational Institutes of Health (U.S.)Peer ReviewUnited StatesWorld Health OrganizationClinical trials as topic/legislation and jurisprudenceGovernment regulationPublication biasRegistries

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.