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A major non-profit advocacy group is asking that a large government trial comparing treatments for sepsis be shut down.

Critics Demand Stop to ‘Guinea Pig’ Sepsis Clinical Trial

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Clovers trial seeks to determine which IV fluids, vasopressors combo works best to curb sepsis
Half of trials on the European Union Clinical Trials Register are non-compliant with the European Commission's requirement that all trials post results to the registry within 12 month of completion

Compliance With Requirement to Report Results on EUCTR Is Poor

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Half of trials on European Union Clinical Trials Register are non-compliant with requirements
The median data age in clinical trials in journals with a high impact factor is about three years at publication

Data Age in Clinical Trials Is About Three Years at Publication

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Trials funded by government were associated with significantly longer time to publication
Published trials have larger treatment effects than unpublished trials

Publication Characteristics Tied to Treatment Effects

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Larger tx effects for published versus unpublished trials; larger effects in non-English publications
Few participants in clinical trials have strong concerns about the risks of data sharing

Most Research Participants Not Concerned About Data Sharing

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93 percent very or somewhat likely to allow their data to be shared with university scientists
Few participants in clinical trials have strong concerns about the risks of data sharing

Most Research Participants Not Concerned About Data Sharing

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93 percent were very or somewhat likely to allow their data to be shared with university scientists
Rural and urban cancer patients with uniform care access through participation in a SWOG (formerly the Southwest Oncology Group) treatment trial have similar outcomes

Similar Outcomes for Rural, Urban Cancer Patients in SWOG Trials

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Few differences between rural, urban patients in cancer outcomes with uniform access to cancer care
Use of appropriate statistical methodology can allow for the synthesis of data collected as part of traditional clinical trials with real-world data

Tools, Methods of RCTs Can Be Adapted to Real-World Settings

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3 options described for applying approaches used in randomized controlled trials to real-world data
There have been 11 lung-related infant deaths after pregnant women in the Netherlands were given sildenafil (Viagra) to boost the growth of their babies while in the womb.

11 Infant Deaths Halt Trial of Sildenafil in Pregnant Women

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Aim of the trial was to improve blood flow to the placenta and promote fetal growth
Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization

Trials Supporting FDA Approval of Breakthrough Drugs Examined

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Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups