PubMed · 11366237
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J S James. 1999-02-19. Strategy trials: the answer?. https://pubmed.ncbi.nlm.nih.gov/11366237/
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Incremental progress will likely continue to be made in the treatment of lung cancer using the conventional treatment modalities. However, there is now hope that the development of noncross-resistant modalities that can be accomplished using the technology of gene transfer may hasten the progress made in this disease. Although significant progress has been made, the practical application of the various strategies to the treatment of cancer patients in clinical trials has yielded only very limited results. For the strategies of introducing suicide genes, replacing defective tumor-suppressor genes, and inactivating oncogenes, considerable progress will need to be made particularly with regard to the ability of vectors to selectively and efficiently target tumor cells in order for many of these strategies to become effective. With regard to the application of gene therapy to immunotherapy, major responses are not likely at this time since these innovative therapies are being developed in patients with advanced disease. However, it is very likely that these pioneering clinical trials will provide important clinical and immunological information that will be the basis for future attempts to effectively harness the immune system against lung cancer.
BACKGROUND: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards. METHODS: From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials. RESULTS: Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items. CONCLUSIONS: Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed.
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