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The quality of atrial fibrillation/atrial flutter trials is variable

Variation in Quality of Trials for Atrial Fibrillation, Flutter

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Most common trial endpoint is AF/AFL recurrence; rates of primary clinical endpoints are low
Many organizations are not meeting the trial registration and results reporting requirements clarified by "The Final Rule

Many Organizations Not Meeting Trial Reporting Requirements

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Only 19 percent of organizations use computer software to monitor compliance with Final Rule
The majority of caregivers of children with food allergy are willing to consider participation in clinical trials for food allergy immunotherapy

Most Parents Willing to Enroll Child in Food Allergen Trials

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Higher parental income only significant positive predictor of willingness to enroll child in trial
Trials to evaluate drugs or devices used to treat chronic medical conditions that are published early in the chain of evidence often show an exaggerated treatment effect compared with subsequent trials

Early Studies Often Show Exaggerated Treatment Effect

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Findings based on assessment of trials evaluating drugs, devices to treat chronic medical conditions
Almost half of clinical trials for prostate cancer use criteria that disproportionately exclude black men

Criteria for Prostate Cancer Trials Disproportionately Exclude Blacks

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Trials sponsored by academic investigators, cooperative groups more likely to use these criteria
Spin in biomedical literature (also referred to as "science hype") is prevalent

‘Science Spin’ Found Prevalent in Biomedical Literature

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Nature of spin varies, with highest variability in prevalence of spin seen in trials
Studies often fail to include information on outcomes by medication adherence in type 2 diabetes

Studies Often Fail to Include Info on T2DM Medication Adherence

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Relative risks of good versus poor adherence to meds reduced for all-cause mortality, hospitalization
The Affordable Care Act may have enabled more privately insured patients to enroll in clinical trials for cancer treatments

More Patients Enrolled in Cancer Trials Under ACA

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Insurer approval rates rose from ~85 percent before Affordable Care Act to ~95 percent after
Many men in the control arm of a screening trial undergo prostate-specific antigen testing during 15 years of follow-up

PSA Testing Frequency High in Control Arm of Screening Trial

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Over 15 years of follow-up, considerable proportion of men undergo prostate-specific antigen testing
For development of oncology drugs in Japan

Strategies Compared for Cancer Medication Submission Lags

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Shorter submission lag for global trial, early-initiation bridging strategy vs late-initiation strategy