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A26 A functional paradigm for clinical trial design
Abstracts
409
physicians. These benefits are compelling. However, these benefits must be carefully weighed with the need to retain scientific rigor. For instance, to determine the necessity for technician training, we sampled measurement error among community ophthalmic technicians. Errors of misclassification were 10% and higher for the study endpoint. This would have necessitated a costly 40% increase in sample size. The cost-effective solution, in lids case, was to retain technician training. Most technicians will be trained and certified by telephone. On going quality control will be achieved by rapid FAX/OCR editing of case-report forms. To insure that study procedures were consistent with community practice, we surveyed members of the American Glaucoma Society. This survey proved crucial in standardizing study equipment, procedures, implementing double-masking and selection of study endpoints. The OHTS has successfully integrated many features of a community-based trial while retaining most of the rigor and quality control associated with traditional randomized clinical trials. A25 COOPERATIVE CLINICAL TRIALS IN HEALTH SERVICES RESEARCH IN THE DEPARTMENT OF VETERANS AFFAIRS William G. Henderson
VA Hospital Hines, Illinois In the next few decades there is projected to be a large increase in the demand for health services in the Department of Veteran Affairs (DVA) due to the aging veteran population. In response to this situation, Congress has increased the DVA budget for health services research in hopes of making the health care delivery system more cost-effective. The DVA has started a new program in multicenter cooperative clinical trials in health services research. Three new coordinafng centers have been established in Hines, minois, Palo Alto, California, and Seattle, Washington. Cooperative clinical trials in health services research present some unique features compared to biomedical studies. The interventions sometimes involve reorganization of clinics. Because the interventions are often complex, relatively long feasibility phases prior to the main trial are needed. The unit of randomization and analysis can either be the clinic or the patient. Outcome variables, such as functional status, patient satisfaction and quality of life are often measured with less precision than outcome variables in biomedical trials. Utilization and costs of health services are otten of importance in these trials and the distribution of these variables departs in extreme fashion from Gaussian. Seven new trials have been assigned to the Hines Coordinating Center. Lessons learned from the planning of these trials and how the unique features described above were handled will be discussed. A26 A FUNCTIONAL PARADIGM FOR CLINICAL TRIAL DESIGN Mary Lou Greenfield and Mary C. Proctor
University of Michigan Medical Center Ann Arbor, Michigan Effective development and implementation of a clinical trial requires a proactive, dynamic process. Failure to provide this process will necessitate reactive management with a loss of the dynamic quality. We have developed a paradigm for clinical trial design and implementation which focuses upon function unified by an extensive communication process. Four phases of clinical trial conduct are identified: conceptualization, organization, initiation and implementation. Four related functions are described: originators, collaborators, facilitators and providers. The characteristics of each function are reported and the communication pathway which unites them is explored. The emphasis on function versus job classification or title allows developers to focus on the process to be initiated and allows individuals to perform various functions at different periods during the study. This paradigm highlights the need for a feedback mechanism which supports the process by allowing developers to recognize needs and modify the process without major design alterations. This prevents "fixing" the structure which would impede optimal development. We discuss this paradigm using examples from the clinical trials which led to its development and then describe the process by which it was validated.
409
physicians. These benefits are compelling. However, these benefits must be carefully weighed with the need to retain scientific rigor. For instance, to determine the necessity for technician training, we sampled measurement error among community ophthalmic technicians. Errors of misclassification were 10% and higher for the study endpoint. This would have necessitated a costly 40% increase in sample size. The cost-effective solution, in lids case, was to retain technician training. Most technicians will be trained and certified by telephone. On going quality control will be achieved by rapid FAX/OCR editing of case-report forms. To insure that study procedures were consistent with community practice, we surveyed members of the American Glaucoma Society. This survey proved crucial in standardizing study equipment, procedures, implementing double-masking and selection of study endpoints. The OHTS has successfully integrated many features of a community-based trial while retaining most of the rigor and quality control associated with traditional randomized clinical trials. A25 COOPERATIVE CLINICAL TRIALS IN HEALTH SERVICES RESEARCH IN THE DEPARTMENT OF VETERANS AFFAIRS William G. Henderson
VA Hospital Hines, Illinois In the next few decades there is projected to be a large increase in the demand for health services in the Department of Veteran Affairs (DVA) due to the aging veteran population. In response to this situation, Congress has increased the DVA budget for health services research in hopes of making the health care delivery system more cost-effective. The DVA has started a new program in multicenter cooperative clinical trials in health services research. Three new coordinafng centers have been established in Hines, minois, Palo Alto, California, and Seattle, Washington. Cooperative clinical trials in health services research present some unique features compared to biomedical studies. The interventions sometimes involve reorganization of clinics. Because the interventions are often complex, relatively long feasibility phases prior to the main trial are needed. The unit of randomization and analysis can either be the clinic or the patient. Outcome variables, such as functional status, patient satisfaction and quality of life are often measured with less precision than outcome variables in biomedical trials. Utilization and costs of health services are otten of importance in these trials and the distribution of these variables departs in extreme fashion from Gaussian. Seven new trials have been assigned to the Hines Coordinating Center. Lessons learned from the planning of these trials and how the unique features described above were handled will be discussed. A26 A FUNCTIONAL PARADIGM FOR CLINICAL TRIAL DESIGN Mary Lou Greenfield and Mary C. Proctor
University of Michigan Medical Center Ann Arbor, Michigan Effective development and implementation of a clinical trial requires a proactive, dynamic process. Failure to provide this process will necessitate reactive management with a loss of the dynamic quality. We have developed a paradigm for clinical trial design and implementation which focuses upon function unified by an extensive communication process. Four phases of clinical trial conduct are identified: conceptualization, organization, initiation and implementation. Four related functions are described: originators, collaborators, facilitators and providers. The characteristics of each function are reported and the communication pathway which unites them is explored. The emphasis on function versus job classification or title allows developers to focus on the process to be initiated and allows individuals to perform various functions at different periods during the study. This paradigm highlights the need for a feedback mechanism which supports the process by allowing developers to recognize needs and modify the process without major design alterations. This prevents "fixing" the structure which would impede optimal development. We discuss this paradigm using examples from the clinical trials which led to its development and then describe the process by which it was validated.