PhRMA Joins with National Minority Quality Forum and Microsoft to Address Diversity in Clinical Trials

NMQF: June 18, 2013 The Pharmaceutical Research and Manufacturers of America (PhRMA) announced today that it is partnering with the National Minority Quality Forum (NMQF) and Microsoft to help increase diversity in clinical trials. “Promoting awareness and creating connectivity that can translate into enhanced participation in clinical trials by a diverse patient population is a priority […]

ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study

BMC Medical Research Methodology: June 18, 2013 Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts […]

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents

Trials: June 19, 2013 Background One mechanism to increase participation in research is to solicit potential research participants’ general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. Purpose The objective is to enable the collection of […]

The Long Term Multi-Center Observational Study of Dabigatran Treatment in Patients with Atrial Fibrillation: (RELY-ABLE) Study

CIRCULATIONAHA:  June 14, 2013 Background—During follow up of between 1 and 3 years in the RE-LY trial, two doses of dabigatran etexilate were shown to be effective and safe for prevention of stroke or systemic embolism in patients with atrial fibrillation (AF). There is a need for longer term follow up of patients on dabigatran […]

Effect of B-Vitamins and Lowering Homocysteine on Cognitive Impairment in Patients With Previous Stroke or Transient Ischemic Attack

STROKEAHA: June 13, 2013 Background and Purpose—High plasma total homocysteine (tHcy) has been associated with cognitive impairment but lowering tHcy with B-vitamins has produced equivocal results. We aimed to determine whether B-vitamin supplementation would reduce tHcy and the incidence of new cognitive impairment among individuals with stroke or transient ischemic attack ≥6 months previously. Methods—A […]

Why caution is recommended with post-hoc individual patient matching for estimation of treatment effect in parallel-group randomized controlled trials: The case of acute stroke trials

Statistics in Medicine: June 12, 2013 A post-hoc individual patient matching procedure was recently proposed within the context of parallel group randomized clinical trials (RCTs) as a method for estimating treatment effect. In this paper, we consider a post-hoc individual patient matching problem within a parallel group RCT as a multi-objective decision-making problem focussing on […]

New National Public Opinion Poll Shows Majority of Americans Would Participate in Clinical Trials if Recommended by Their Doctor

Research America: June 12, 2013 More than two-thirds (72%) of Americans say it’s likely they would participate in a clinical trial if recommended by their doctor, but only 22% say a doctor or other health care professional has ever talked to them about medical research, according to a new national public opinion poll commissioned by […]

End of Study Transition From Study Drug to Open-Label Vitamin K Antagonist Therapy

CIRCOUTCOMES: June 11, 2013 Background—To evaluate the previously reported excess of thromboembolic events during the 30 days after the end of study (EOS) visit when participants transitioned from blinded therapy to open-label vitamin K antagonist. Methods and Results—At the EOS visit, open-label vitamin K antagonist was recommended, and the international normalized ratio (INR) was not to […]

Progression of Atrial Fibrillation after a Failed Initial Ablation Procedure in Patients with Paroxysmal Atrial Fibrillation: A Randomized Comparison of Drug Therapy vs. Re-Ablation

AHA – June 7, 2013 Background—The aim of this prospective randomized study was to assess if an early re-ablation was superior to AAD therapy in patients with previous failed PVI. Methods and Results—Patients with paroxysmal AF eligible for AAD therapy or re-ablation after a previous failed initial PVI procedure were eligible for this study and […]

Dabigatran Versus Warfarin

Effects on Ischemic and Hemorrhagic Strokes and Bleeding in Asians and Non-Asians With Atrial Fibrillation Background and Purpose—Intracranial hemorrhage rates are higher in Asians than non-Asians, especially in patients receiving warfarin. This randomized evaluation of long-term anticoagulation therapy subgroup analysis assessed dabigatran etexilate (DE) and warfarin effects on stroke and bleeding rates in patients from […]

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