THE CONDUCT OF CLINICAL-TRIALS AND GOOD CLINICAL PRACTICES - THE SPONSORS PERSPECTIVE

The Guideline, ''Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies,'' which was issued by the Center for Veterinary Medicine (CVM) in October 1992 is intended to improve standards of clinical re search. The purpose of clinical trials is to obtain data to support do se selection and to confirm the dose for regulatory approval of New An imal Drug Applications (NADA). The processes and procedures described in the Guideline should improve the ''fitness for use'' of data from c linical trials. Clinical investigators who desire to work with drug sp onsors must understand the tenor of the Guideline and implement its re commendations when conducting pivotal clinical research. Protocols in which procedures are clearly described and responsibilities for monito rs and investigators defined, in concert with a preplanned definitions of source data supported by appropriate quality control and quality a ssurance procedures, will ensure that the basis of approval for new an imal drugs is defensible.