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Cancer clinical trials in the USA: patient eligibility, generalizability of results and technology transfer.

The impact of changes in the source population of patients for cancer clinical trials in the USA is considered. The first change, which has already taken place, is the recent trend of including patients treated of community hospitals in cooperative group and other randomized trials. This change was designed to augment accrual to studies, and to disseminate state-of-the-art information on patient care. The change has been shown to be a successful one, with community hospitals providing high quality participation in the trials. In addition, the research protocols have been seen to influence the care of many patients treated off-protocol. The inclusion of community hospitals in the trials clarifies our understanding of the generalizability of the results of the trials. The issue of generalizability is, however, obscured by the fact that the great majority of cancer patients are not treated on protocols. Indeed most of them are ineligible for protocols. The rationale for strict eligibility is unclear in many cases, and its use greatly reduces accrual and casts doubt on the generalizability of results. In the future, more care should be paid to the selection of the source population for clinical trials.

Clinical Trials as Topic↗

Skin cancer/melanoma public and professional education in Hawaii: an integrated approach to technology transfer.

The CCPH skin cancer/melanoma education components which have been implemented to date have had an impact on the public and professional target audiences. The comic book/TV/radio media campaign, conducted during the summer months of 1981, appears to have raised public skin cancer/melanoma knowledge levels and positively affected behavior. Results of the physician training sessions also suggest immediate posttraining gains. Follow-up data may provide evidence of long-term knowledge and behavior change. Materials for health and personal services professionals are in final production and, based on the success of completed components, should contribute to improved skin cancer prevention, detection and treatment practices in Hawaii.

Education, Medical, Continuing↗

Application of gene transfer technologies to the production of enzyme reference materials: example of gamma-glutamyltransferase.

Protein reference materials are traditionally prepared by purification from mammalian or human tissues. The supply of these tissues is limited; consequently, there is a growing need for applied molecular and cellular biology technologies for the production of human recombinant proteins. This is especially true when only small amounts of the proteins are available in the tissues. We review the current knowledge necessary for high-level production of such proteins in different heterologous expression systems, using our data on gamma-glutamyltransferase (EC 2.3.2.2) as an example. We describe the steps required to achieve the expression of enzymes and other proteins in Escherichia coli, yeast, or mammalian cells. We list many of the problems investigators may face in preparing recombinant proteins, and provide information on selecting the most appropriate system as well as the most favorable experimental conditions. Depending on the expression system, recombinant proteins can potentially be obtained for most, if not all, enzymes of interest in clinical chemistry, and such proteins should possess characteristics very similar to those of the corresponding human native proteins. Studies suggest that these products can be used as reference materials in clinical chemistry laboratories.

Animals↗