Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development.

ABSTRACT: Oncology drug development is among the most challenging of any therapeutic area, with first-in-human trials expected to deliver information on both safety and activity. Until recently, therapeutic approaches in oncology focused on cytotoxic chemotherapy agents, ruling out even the possibility of enrolling normal healthy volunteers (NHVs) in clinical trials due to safety considerations. The emergence of noncytotoxic modalities, including molecularly targeted agents with more favorable safety profiles, however, has led to increasing numbers of clinical pharmacology studies of these agents being conducted in NHVs. Beyond rapid enrollment and cost savings, there are other advantages of conducting specific types of studies in NHVs with the goal of more appropriate dosing decisions in certain su

SUBMITTER: Ahmed MA 

PROVIDER: S-EPMC6951451 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature