The US Food and Drug Administration (FDA) has offered guidance for exploratory investigational new drug (IND) studies to help streamline the earliest phases of clinical research in the development of life-saving medical interventions for cancer patients. This novel concept has been a major focus for the joint National Cancer Institute (NCI)-FDA Interagency Oncology Task Force (IOTF), which was established in 2003 to enhance and accelerate the overall process of developing new cancer diagnostics and therapeutics. The ability to study very small doses of experimental agents will allow researchers to test promising drugs and get information about their distribution and activity in the human body. This guidance will not only benefit the development of new cancer interventions, but has implications across drug and biologics development for all diseases.
“The FDA exploratory IND guidance documents are important steps in fulfilling our goals to help streamline cancer drug development by identifying the gaps and barriers that can be addressed through new approaches and new applications of scientific evidence,” said NCI Deputy Director Anna D. Barker, PHD. “Working through the IOTF, we were able to crystallize opportunities to accelerate progress in the cancer drug development process that will be enabled by this new FDA guidance.”
The guidance documents announced by the FDA are designed to increase the number of agents that can be tested in microdoses in small numbers of patients, which will allow many more agents to be evaluated before entering into a phase I clinical trial. This will enable researchers to conduct early proof-of-principle evaluations of compounds and target effects to identify the most promising drugs for more extensive testing.