Exploratory investigational new drug (IND) studies, which are also called phase 0 trials, will facilitate targeted therapies being tested in patients earlier in the drug development process. These trials are an integral part of the joint early therapeutics development program, the latest collaborative effort between DCTD and Center for Cancer Research that is known as the NCI Experimental Therapeutics Program (NExT). This initiative uses pharmacokinetic and pharmacodynamic principles to streamline the development of novel cancer therapeutics by rapidly screening new drugs in humans before making a commitment in time and resources to a full therapeutic development plan.
NCI investigators provide clinical trial expertise, a national clinical development infrastructure, and a relationship with pharmaceutical companies to the new exploratory IND trials. These studies will perform first-in-human mini-trials that will validate the initial scientific rationale of a new drug by gathering pharmacological data directly from human volunteer patients. CTEP’s role is to oversee the clinical development. Other DCTD programs also are involved in this joint venture, including the Developmental Therapeutics Program, the Cancer Diagnosis Program, CIP, and RRP.