Applied Clinical Trials-03-01-2005

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

The benefits of clinical site networks may outweigh the costs when sponsors consider the enhanced quality and timeliness as well as potential impact on enrollment.

Meeting today's drug development challenges by better preparing study coordinators

A simple game of chance clears up the confusion over what randomization can and cannot do.

Informed consent takes place in the brain. While that seems obvious, the implications of that statement go much deeper. To a great extent, both bioethics and federal policy are based on 17th century assumptions by philosophers such as Descartes-who knew nothing of the structure and function of the brain.

The Declaration of Helsinki requires that control groups receive the “best” current treatment, not the “local” one. This shift in wording has profound implications.

Will the new pediatric and ethics initiatives receive enough funding to make them truly work?

A challenge that intersects the global community

New policies aim to simplify testing for single-pill combos and products that combine drugs with medical devices.