EMA Releases Guideline on Conducting Clinical Trials for Atrial Fibrillation Products

clinicatrials2

Raps.org: By Alexander Gaffney, 8/15/12 The European Medicines Agency (EMA) has released a new guideline for sponsors of products to prevent strokes in patients with non-valvular atrial fibrillation (AF). EMA notes the guideline fills a void left by other guidance documents on antiarrhythmics used to prevent AF, which do not address stroke prevention and systemic embolic events […]

Novel incentive-based approaches to adherence

Ctj.sagepub.com: July 30, 2012. Background Adherence to medications for chronic conditions is often very low, limiting the benefit to patients, even when the medications are effective and have favorable side effect profiles. Purpose This article reviews some of the prior work on treatment adherence, introduces novel concepts from behavioral economics that can be used to design interventions to […]

The Importance of Potential Studies That Have Not Existed and Registration of Observational Data Sets

American Medical Association: August 8, 2012 Knowing the complete results of all conducted studies on a question of interest is important to avoid publication and selective outcome reporting biases1 and to obtain a reliable picture of the evidence. However, in many types of research, the problem of selectively missing information does not pertain only to studies that […]

The Combined Impact of Virtual Reality Neurorehabilitation and Its Interfaces on Upper Extremity Functional Recovery in Patients With Chronic Stroke

American Heart Association: 8/7/12 Although there is strong evidence on the beneficial effects of virtual reality (VR)-based rehabilitation, it is not yet well understood how the different aspects of these systems affect recovery. Consequently, we do not exactly know what features of VR neurorehabilitation systems are decisive in conveying their beneficial effects. Methods—To specifically address this […]

The effectiveness of dual antiplatelet treatment in acute ischemic stroke patients with intracranial arterial stenosis: a subgroup analysis of CLAIR study

Onlinelibrary.wiley.com: AUG 7, 2012 Dual antiplatelet therapy with clopidogrel and aspirin reduces the presence and number of microembolic signals in patients with large artery disease. However, whether it is effective in patients with intracranial disease alone remains uncertain. We performed a subgroup analysis of the The CLopidogrel plus Aspirin for Infarction Reduction (CLAIR in acute stroke […]

Developing core outcome sets for clinical trials: issues to consider

Trialsjournal.com: August 6, 2012 Selection of appropriate outcomes or domains is crucial when designing clinical trials to compare directly the effects of different interventions in ways that minimise bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, […]

Some thoughts on sample size: A Bayesian-frequentist hybrid approach

The Society for Clinical Trials: August 3, 2012 Background Traditional calculations of sample size do not formally incorporate uncertainty about the likely effect size. Use of a normal prior to express that uncertainty, as recently recommended, can lead to power that does not approach 1 as the sample size approaches infinity. Purpose To provide approaches for calculating sample […]

Statistics from ISRCTN Register

Controlled-trials.com: 7/30/12 All the information is as of June 2012. Figures given below represent the number of trials added to the ISRCTN Register or ClinicalTrials.gov per year or per month, not the number of trials started or taking place at any particular moment in time. Study domains represented in ISRCTN register: the ISRCTN disease classification is […]

Poststroke Balance Improves With Yoga

Stroke.ahajournals.org: 7/26/12 Balance impairment is common after stroke; modified yoga may be able to improve balance and other important poststroke variables. Scientific-evidence is needed to support such treatment interventions. The purpose of this study was to assess the impact of a yoga-based rehabilitation intervention on balance, balance self-efficacy, fear of falling (FoF), and quality of life […]

United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study

There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators’ role in clinical investigation. Our objective was to study private-sector clinics involved […]

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