Applied Clinical Trials-02-01-2003

With the rapid geographical expansion of clinical trials, industry professionals are increasingly willing to set up studies in exotic locations. Although their initial concerns about the quality of data from far-flung studies have dissipated, debate continues about the ethics of performing trials in new locations, especially in developing nations.

Mock inspections can effectively test the preparedness of a site or sponsor-and also train employees to handle a real FDA inspection.

The latest wrinkle in the European Union?s clinical trials rules debate comes from modifications of the draft text at the core of its proposal.

Sponsors tackle international research challenges to develop AIDS, malaria, and TB therapies for developing nations.

It may seem impossible to do what we know is right?to try to save time and money by spending time and money.

To minimize time to market, sponsors must explore new subject recruitment techniques.

What happens in the six months before a trial is just as important as what happens during the trial.