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Pharmaceutical Executive: The Power of Observation
January 30, 2012
Observational studies present a compelling real-world corollary to the classic randomized clinical trial. Download this article to learn how you can build your evidence portfolio. -
Registries for Evaluating Patient Outcomes: A User's Guide
January 30, 2012
Outcome leads the development of best practices for designing and implementing patient registries for real-world observational research. Download the Agency for Healthcare Research & Quality (AHRQ) 2nd edition of Registries for Evaluating Patient Outcomes. -
The Power of Observation
January 26, 2012
As the name implies, in observational studies one 'observes.' The choice of therapy is determined by the patient and her physician rather than protocol, and, -
Making Observational Studies Count
January 26, 2012
There is substantial interest in using observational epidemiologic research in combination with randomized clinical trials (RCTs) and meta-analyses to support decisionmaking by regulators, payers, and -
Patient Registries for Understanding the Natural History of Diseases
January 26, 2012
Understanding the natural history of a disease - its characteristics. management. and outcomes with or without treatment - is critical for developing new therapies. identifying -
GRACE Principles: Recognizing High-Quality Observational Studies of Comparative Effectiveness
January 26, 2012
Comparative effectiveness (CE) has been defined as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, -
The Contribution of Early-phase Clinical Data to a Drug’s Integrated Cardiac Safety Portfolio
January 16, 2012
This article examines the financial and time benefits to incorporating intensive ECG and QT/QTc monitoring in early-phase clinical studies. -
Optimising Patient-Centric Services
December 19, 2011
The cost of avoidable hospitalisations and disease progression in the United States has reached the unprecedented level of some $290bn per year; in turn these -
Regulatory Implications of Technology Platforms for Patient-Centric Services
December 19, 2011
The rise in healthcare costs has outpaced Gross Domestic Product (GDP) growth since the 1970s. Contributing factors are avoidable hospitalizations and disease progression that add -
Why Do I Need Regulatory Affairs Certification (RAC)?
December 19, 2011
Regulatory Affairs Certification (RAC) is the badge that proves the person carrying it has done the legwork to speak authoritatively in matters that are vital
