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Applied Clinical Trials-09-01-2005
Applied Clinical Trials
eShowcase
September 01, 2005
eShowcase
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Galt Associates (Sterling, VA) has brought together the original Halo web-based safety research and monitoring environment with its dsNavigator search engine for a new and improved Halo platform. Featuring streamlined yet powerful querying capabilities, the platform offers ready access to a vast array of information sources-including FDA and WHO datasets-while a sophisticated interface gives safety professionals automated tools and an intuitive way to manage and analyze data.
Low-Hanging Fruit: A Pilot Project to Standardize Case Report Forms
September 01, 2005
Special Section: The Critical Path Initiative-Part Two
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Making important data more consistent and more accessible has the potential to improve safety and efficacy.
Delivering on the eDiary Promise
September 01, 2005
Special Section: The Critical Path Initiative-Part Two
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Thoughtful application of eDiaries can make clinical development much more efficient.
A Declaration of Action
September 01, 2005
Special Section: The Critical Path Initiative-Part Two
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The FDA Initiative represents the challenge facing our industry.
Have We Pushed Our Pis Too Far?
September 01, 2005
Clinical Trial Insights
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Performance, compliance, and financial pressures are hitting investigators hard. What can sponsors and CROs do to help the situation?
Leveraging Clinical Trial Technology: Critical to the Initiative's Success
September 01, 2005
Special Section: The Critical Path Initiative-Part Two
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The clinical trial industry can thrive by offering easy-to-use technology to make data available earlier.
Driving Clinical Trial Innovation
September 01, 2005
Special Section: The Critical Path Initiative-Part Two
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Even with current trial management systems, steps can be taken right now to greatly increase efficiency.
FDA Compliance Priorities and Evolution
September 01, 2005
Feature Article
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This newly updated reference guide addresses the most difficult, emerging, and frequently asked GCP questions today.
Are There Real-World Benefits to the Critical Path Initiative?
September 01, 2005
Special Section: The Critical Path Initiative-Part Two
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As laudable as it may appear to be, the Critical Path Initiative will create as many problems as it solves.
Critical Path Initiative: A Conversation with Janet Woodcock, MD
September 01, 2005
Special Section: The Critical Path Initiative-Part Two
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The "Critical Path" is the scientific process through which a potential pharmaceutical, or medical device is transformed from a discovery into a medical product. Along the critical path, scientific tests and tools are used to predict whether a product candidate will be safe and effective, to assess how prototypes interact with the human body, and to guide the sponsor in choosing an appropriate dose and regimen or device size and/or placement. To bring a product to market successfully and efficiently, product sponsors need scientifically sound approaches.
Phase III Failures: What Can Be Done?
September 01, 2005
A Closing Thought
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Much has been written about the staggering costs of drug development and how the low Phase III success rates across the pharma industry have contributed to these costs. While safety outcomes explain many failures during the early development phase and have likewise played a prominent role in some highly publicized product withdrawals, efficacy failures in Phase III have received little attention. What we now know, however, is that a significant number of Phase III failures are attributable neither to issues of safety nor product differentiation, but to an inability to confirm efficacy against placebo.
New Era at FDA
September 01, 2005
View from Washington
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Commissioner Crawford's challenge is to restore public confidence in drug safety and approvals.