Clinical Trials Agreement

Between pharmaceutical company and National Cancer Institute for development of new drug

Summary | Correlation Table

CLINICAL TRIALS AGREEMENT BETWEEN [NAME OF PHARMACEUTICAL COMPANY] AND THE DIVISION OF CANCER TREATMENT AND DIAGNOSIS, NCI FOR THE CLINICAL DEVELOPMENT OF [NAME OF DRUG]

The Division of Cancer Treatment and Diagnosis (“DCTD”), National Cancer Institute (“NCI”), recognizes the importance of the pharmaceutical industry in the clinical development of new anti-cancer agents. DCTD wishesfoster collaboration with industry whenever possible. As part of its missionimprove cancer care, DCTD shares with industry the important goal of defining the contribution of a new drug or biologic in the treatment of cancer. DCTD therefore recognizes and supports the need of a private sponsorfocus at the appropriate time on clinical trials which leada New Drug Application (“NDA”) or a Biologics License Application (“BLA”) since an NDA and a BLA, once approved, are the vehicles through which new anti-cancer therapies become widely availablecancer patients. Thus DCTD considers it appropriate for the investigators sponsored by DCTDdo clinical trials of interest to, and partially supported by a pharmaceutical firm, provided that the trials have scientific merit and are consistent with the overall goals of the investigators and DCTD.

Inasmuch as DCTD coordinates a large volume of clinical research with new anti-cancer agents, industry recognizes DCTD's needbe aware of industry's plans for the clinicaldevelopment of new agents of mutual interest, particularly if a pharmaceutical firm wishesuse the resources of the DCTD-supported clinical trials mechanism. Industry also recognizes the necessity of preserving the spirit of free and open inquiry among clinical investigators.

The following statement serves as the basis for the codevelopment of [name of drug] by Collaborator and DCTD.

SECTION ONE.

DEFINITIONS

“Adverse Event” means an adverse clinical event as defined under  IND Safety Reports and other applicable Federal Regulations. NCI shall establish and maintain records and make reportsthe FDA for the following Adverse Events: (1) all serious, unexpected adverse events, (2) any significant increase in the frequency of serious expected adverse events, and (3) any significant increase in the frequency of therapeutic failures. Specific NIH and NCI guidelines and policies for reporting Adverse Drug Experience, as well as common toxicity criteria, have been developed. These guidelines and policies appear in the “Investigator's Handbook: A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, and Diagnosis, National Cancer Institute.”21 C.F.R. § 312.32