The Clinical Trials Core is organized to support all aspects of the clinical studies associated with the Molecular Oncology Program Project, including the design of protocols, recruitment of patients, pharmacokinetic analysis of anti-tumor agents, and statistical analysis of clinical and laboratory data. The four components of the Clinical Trials Core are Clinical Data Management, Research Data Management, Biostatistics, and the Clinical Pharmacology Laboratory. The functions of Clinical Data Management are to assist in patient enrollment, manage clinical trials data, and assure the quality of the data for all three projects. Research Data Management will develop disease-specific data bases for all MOPP cancers similar to the myeloma data base. Biostatistics will work closely with all MOPP investigators to develop timely statistical analyses of the clinical and laboratory endpoints of each of the nine clinical protocols. The Clinical Pharmacology Laboratory will provide pharmacokinetic analyses of several of the anti-tumor agents used in the clinical protocols, so that the project leaders can address their correlative laboratory hypotheses. Thus, the goals of the Clinical Trials Core are: (1) to facilitate and coordinate the clinical and statistical design of Phase I and II trials in the MOPP and to help recruit eligible patients for these studies; (2) to provide clinical management of patients on MOPP protocols and to collect, store, and analyze both the clinical outcome data and laboratory data for each protocol; (3) to provide correlative pharmacokinetic and pharmacodynamic drug analyses for specific protocols; and (4) to assist with the development and implementation of future protocols, based on knowledge gained from the initial MOPP studies. Specific areas that will be developed the Clinical Trials Core that will enhance support of ongoing and future MOPP protocols, the development of disease-specific laboratory databases for all cancers studied in the MOPP application, and to use the Clinical Pharmacology Laboratory to pursue novel patient treatment modalities.
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