The National Cancer Institute (NCI) agent formulary (NCI Formulary) was launched on January 11, 2017 as one of the first efforts of the Cancer Moonshot initiative. To develop the NCI Formulary, the Cancer Therapy Evaluation Program (CTEP), DCTD, NCI negotiated specific NCI Formulary Clinical cooperative research and development agreements (CRADAs) with pharmaceutical company collaborators that agreed to expand the use of their proprietary agents for studies supported by the NCI Formulary. The NCI Formulary CRADAs provide NCI-audited academic institutions access to these proprietary agents, thus eliminating the often-lengthy agent access process that occurs between such institutions and pharmaceutical companies.
Agents within the NCI Formulary are available to investigators at NCI-audited clinical sites for the conduct of clinical trials under investigator-held investigational new drug applications (INDs), as well as for pre-clinical research. CTEP’s clinical trial infrastructure will facilitate the conduct of the trials, from proposal submission and timely review by the collaborating pharmaceutical companies to agent distribution, serious adverse event submission, and clinical data reporting, while providing a coordination mechanism between the clinical investigators and the pharmaceutical company collaborators. A clinical Material Transfer Agreement between NCI and the clinical sites will formalize the expectations of each party.
To date, CTEP has successfully negotiated CRADAs with 9 different pharmaceutical companies to bring 27 different agents into the NCI Formulary. All of these potential cancer treatments are now available to over 300 different cancer centers and clinical trial sites that have been audited by NCI. One of the big advantages of the program is the ease with which combination trials can be set up using the Formulary. In addition, applications can be made by academic investigators to use the agents in non-clinical research.
The NCI Formulary allows for:
- Negotiation-free access to investigators through the NCI template agreement with the participating companies
- Less time to acquire the agents
- Unique opportunities to obtain agent from multiple companies to combine in one study
- The distribution of agents to occur at no cost to the investigator
- Enhances the clinical trial implementation process
- The Investigator to have control over the initial publication and presentation of the results
- An evolving list of agents from collaborating companies (see nciformulary.cancer.gov).