Applied Clinical Trials-09-01-2005

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.

Making important data more consistent and more accessible has the potential to improve safety and efficacy.

Thoughtful application of eDiaries can make clinical development much more efficient.

The FDA Initiative represents the challenge facing our industry.

Performance, compliance, and financial pressures are hitting investigators hard. What can sponsors and CROs do to help the situation?

The clinical trial industry can thrive by offering easy-to-use technology to make data available earlier.

Even with current trial management systems, steps can be taken right now to greatly increase efficiency.

This newly updated reference guide addresses the most difficult, emerging, and frequently asked GCP questions today.

As laudable as it may appear to be, the Critical Path Initiative will create as many problems as it solves.

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.

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.

Commissioner Crawford's challenge is to restore public confidence in drug safety and approvals.