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Comprehensive Pharmacovigilance and eHealth Surveillance
The monitoring of newly approved drugs for safety, primarily by the pharmacovigilance of voluntary adverse event reporting, is broadly recognized as being haphazard, slow, and inaccurate. This paper proposes an alternative method of integrating comprehensive pharmacovigilance with eHealth patient records for automatic, real-time adverse drug event reporting from across very large patient populations.
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Subject Diversity Is Good for the Business of Medicine
With the advent of personalized medicine and purported "race-based therapies" such as BilDil in the news, it is time the pharmaceutical industry makes a more concerted effort to engage racial and ethnic minority groups and the rural poor in clinical research.
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Raising the Standards for Clinical Integration
Estimates suggest that biopharmaceutical companies spend more than $150 million per year on data exchange. The industry needs to work smarter, faster, and with fewer resources.
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Standardizing CTAs: International Efforts
Most pharmaceutical companies place a high priority on reducing their costs to offset pressure on profit margins. They also struggle to accelerate the development of profitable new drugs: Based on drug sale statistics, pharmaceutical companies lose substantial revenue each day a new drug is delayed from reaching the market.
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Probing Ethics in Human Research
Perhaps a way forward is to refocus our efforts on a "culture of conscience," since our conscience often guides our actions.
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State Regulation of Clinical Trials
For those conducting clinical trials, strict adherence to state regulatory requirements makes sound business sense.
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