Clinical Trials Management
Spotlight

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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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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Features

Hands-On Therapeutic Training

The ideal scenario to deliver global clinical trials is to use project teams that already have conducted one or more studies in the same therapeutic indication. This experience provides the teams a "leg up" on preparing the protocol, identifying and selecting sites worldwide, and managing the conduct of the study to produce a quality and on-schedule outcome.
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Approaching Africa

The Declaration of Helsinki requires that control groups receive the “best” current treatment, not the “local” one. This shift in wording has profound implications.
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Educating the Public: A Critical, Unmet Need

During the past decade, spending on patient recruitment programs has grown 16% annually. In that same period, volunteer randomization rates have declined.
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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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