PubMed · 9365485
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M Griffiths. 1997-11-08. "Underpowered" trials.. https://doi.org/10.1016/s0140-6736(05)65189-6
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The Department of Defense (DoD) military health system has responsibility for providing medical care for more than 8 million beneficiaries. This article discusses initiatives related to both the providing and purchasing of oncology services. A description of health care coverage under TRICARE, the Department's managed care program, which utilizes military treatment facilities and civilian health care providers, is provided. Participation in clinical trials by the DoD beneficiaries, oncology services in military treatment facilities, quality management programs, cancer research, and the development of new technologies to enhance early cancer detection are presented. Access to research trials and new technologies is necessary for a comprehensive approach to cancer care. Clinical trials have been the vehicle by which the oncology community developed most of its formal clinical evidence for the efficacy of various treatment approaches. The Department participates in clinical trials through cooperative group membership or affiliation. Through an interagency agreement with the National Cancer Institute, DoD beneficiaries have available the option of participating in NCI-sponsored clinical trials through the direct military care system or through civilian care with reimbursement for approved protocols nationwide. The DoD has been actively involved in breast cancer research since 1992 and prostate and ovarian cancer research since 1997. The goals of the cancer research programs are to expedite and facilitate breakthroughs in research, support innovative, and exploratory ideas with a vision to foster new directions, address neglected issues, and bring new investigators into the research arena. The program incorporates the consumer perspective by involving consumers in the decision-making process. The DoD health care system trains experts in the management of cancer patients and provides a multidisciplinary approach to care through the direct military health care system or through network providers as part of the TRICARE system. Although cost containment is key, the delivery of high quality health care that is easily accessible is a primary goal of the military health system. Provision of a comprehensive benefits package that includes a spectrum of care and employing outcomes measurements to evaluate care that is appropriate for the patient's disease is essential.
Human gene therapy trials directed at hereditary diseases, including adenosine deaminase (ADA) deficiency, familial hypercholesterolemia, and cystic fibrosis, are reviewed. Human gene therapy involves the introduction and expression of recombinant genes in somatic, nonreproductive cells with the intent to reverse or prevent a particular disease. Two methods for introducing genes into human cells are currently being used in clinical trials. Ex vivo gene delivery involves removing targeted cells from the patient's body, introducing the recombinant gene into the cells, and placing the modified cells back into the patient's body. In vivo gene delivery involves placing the recombinant gene directly into the patient's body, targeting the tissue or cell of interest. The transfer of the recombinant gene into the cell and the subsequent expression of the transgene product are the rate-limiting steps for successful gene therapy. A variety of methods, including the use of modified viruses and synthetic vectors, are currently being used in clinical trials. Since the approval and initiation of the first human gene therapy trial to treat ADA deficiency in 1989, there have been more than 170 approved gene therapy trials in the United States. More than 1500 patients have been enrolled in human gene therapy trials worldwide. Preliminary clinical trials have targeted diseases such as ADA deficiency, familial hypercholesterolemia, and cystic fibrosis. These trials have employed variable designs and strategies, making interpretation of the results difficult. However, the initial data are encouraging, and the procedures have been well tolerated. The clinical utility of human gene therapy remains to be defined; immediate efforts will focus on improving vector design to limit toxicity and enhance the efficiency of gene transfer.
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