Tag: Clinical Trials
11 Infant Deaths Halt Trial of Sildenafil in Pregnant Women
Aim of the trial was to improve blood flow to the placenta and promote fetal growth
Trials Supporting FDA Approval of Breakthrough Drugs Examined
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups
Variation in Quality of Trials for Atrial Fibrillation, Flutter
Most common trial endpoint is AF/AFL recurrence; rates of primary clinical endpoints are low
Many Organizations Not Meeting Trial Reporting Requirements
Only 19 percent of organizations use computer software to monitor compliance with Final Rule
Most Parents Willing to Enroll Child in Food Allergen Trials
Higher parental income only significant positive predictor of willingness to enroll child in trial
Early Studies Often Show Exaggerated Treatment Effect
Findings based on assessment of trials evaluating drugs, devices to treat chronic medical conditions
Criteria for Prostate Cancer Trials Disproportionately Exclude Blacks
Trials sponsored by academic investigators, cooperative groups more likely to use these criteria
‘Science Spin’ Found Prevalent in Biomedical Literature
Nature of spin varies, with highest variability in prevalence of spin seen in trials
Studies Often Fail to Include Info on T2DM Medication Adherence
Relative risks of good versus poor adherence to meds reduced for all-cause mortality, hospitalization
More Patients Enrolled in Cancer Trials Under ACA
Insurer approval rates rose from ~85 percent before Affordable Care Act to ~95 percent after
