Authorities Recognize a Need to Encourage Pediatric Drug Development

A new reference guide clarifies uncertainty surrounding this sometimes misunderstood document.

Long overlooked as global drug innovators, Japanese pharmaceutical companies are gaining attention for their novel clinical development programs.

Arthur L. Caplan, Ph.D., chair of the University of Pennsylvania's Department of Medical Ethics, expressed his frank views about issues that are ailing the drug industry today during his DIA Keynote Address in mid-June.

New requirements for clinical research teams, and administrative responsibilities and constraints for investigators conducting noncommercial trials.

Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.

The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).