Applied Clinical Trials-04-01-2003

More than 1000 contract research organizations exist worldwide, and the number is growing. CROs differ widely in size and profile. Before a project can be contracted out, sponsors often spend valuable time searching for the CRO that best fits the project's specifications. Consultants are often needed to help hew a path through this jungle, a task made all the more difficult by the intentional withholding of information that would help sponsors decide. The World Wide Web would be an excellent means for CROs to communicate relevant and fluid information about their companies, and herein I offer a model for CROs to use.

For years, clinical trials have been largely sheltered from the liability lawsuit crisis that has plagued other industries. That is changing.

Recruiting children to participate in clinical drug trials is an activity closely scrutinized by regulators, bioethicists, ethics committees, institutional review boards, and the popular press. The FDA acknowledges the vulnerability of pediatric subjects and has implemented heightened regulatory safeguards. Pediatric clinical trials represent a powerful, emotional platform because of the potential for conflict of interest among a number of parties, including pharmaceutical company sponsors, study investigators, and parents.

As the number and complexity of clinical trials grows-lengthening clinical trial durations and raising costs-sponsors and CROs need a way to streamline trial management, shorten study durations, and reduce expenditures. Customer relationship management (CRM) strategies update the paper-intensive methods of the past and offer an innovative approach to managing clinical trials-an approach that focuses on strengthening relationships between trial participants, especially investigators and subjects.

Pediatrics and geriatrics are the latest hot topics in the EU, so the CPMP is at least starting to help companies develop new clinical trials for children.

FDA is revising its policies that govern electronic recordkeeping, clarifying standards for measuring subject outcomes, and seeking to encourage pediatric studies.

If it?s not clear who?s in charge, then no one is?and process improvement can be undermined.

When outsourcing clinical supply activities, you can improve communications efficiency by integrating your supplier's organization system with your own.