摘要:

AbstractRandomized intervention trials play an important role in the identification of practical approaches to reducing major chronic diseases in our society. Very few such trials are likely to be possible, however, in coming years unless we adopt procedures less demanding and less costly than those used in the past. Towards this end some elements of an efficient prevention trial are discussed, including aspects of study design, criteria for eligibility and exclusion, procedures for data collection, follow‐up, endpoint ascertainment, and data analysis, and for ancillary studies. For example, possibilities for enhancing efficiency in the use of endpoint events include the selection of an appropriately weighted test statistic, the use of case‐control or case‐cohort sampling procedures in the processing of covariate data and specimens, and the notion of replacing a disease endpoint by an earlier or less expensive surrogate endpoint. Ideas for enhancing the efficiency of prevention trials will be illustrated in the context of a proposed Dietary Fat Intervention Trial for disease prevention in

ISSN:0277-6715    

DOI:10.1002/sim.4780090123

出版商:Wiley Subscription Services, Inc., A Wiley Company    

年代:1990

数据来源: WILEY

摘要:

AbstractThis study applied a cost‐effectiveness model to seven randomized trials. The model demonstrates the effect of design choices made in the planning stages of a clinical trial on the costs and benefits derived from conducting the trial. The study focused on one parameter used to calculate sample size: the minimum clinically important difference in event rates between control and experimental therapies. The study shows that the model can be operationalized to these trials. A computerized software package and manual has been developed to simplify the calculations. While there was some variation in the incremental cost‐effectiveness ratios across the seven trials in this study, all ratios may be below the funding threshold. This analytical technique can be used to demonstrate explicitly the resource consequences of the design of randomized trials and perhaps to set funding priorit

ISSN:0277-6715    

DOI:10.1002/sim.4780090124

出版商:Wiley Subscription Services, Inc., A Wiley Company    

年代:1990

数据来源: WILEY

摘要:

AbstractDuring recent decades we have seen an encouraging development of trial methodology. Less effort, however, has been devoted to the application of findings of trials to the practice of medicine. We cannot expect results of controiled trials alone to determine standard therapy, for clinical judgements are also required. Both beneficial and adverse effects are often only detectable on the group level. There are generally very few indications that drug effects differ qualitatively in subgroups of patients. It is important not only to prove or disprove effects, but also to find out how to implement a proper therapy for a majority of eligible patients. Four examples from treatment after myocardial infraction show that drug usage may not always be based upon results of clinical trials. The adoption of Swedish guidelines for thrombolytic therapy in acute myocardial infarction is taken as an example of an apparently optimal application of trial results in practice.

ISSN:0277-6715    

DOI:10.1002/sim.4780090125

出版商:Wiley Subscription Services, Inc., A Wiley Company    

年代:1990

数据来源: WILEY

摘要:

AbstractThe application of the results of clinical trials to medical practice depends in part upon the understanding and acceptance of study results by the practising physician. Involving non‐academic practitioners as investigators in streamlined trials is an effective means to increase enrolment and minimize cost. Streamlining data collection to accommodate the needs of the practitioner, however, decreases the amount of scientifically and clinically relevant data that are collected. More important, biased enrolment is more likely in this setting. Modifications in organization and design of the Myocarditis Treatment Trial form an example of streamlining an ongoing clinical trial to enhance enrolmen

ISSN:0277-6715    

DOI:10.1002/sim.4780090126

出版商:Wiley Subscription Services, Inc., A Wiley Company    

年代:1990

数据来源: WILEY

ISSN:0277-6715    

DOI:10.1002/sim.4780090127

出版商:Wiley Subscription Services, Inc., A Wiley Company    

年代:1990

数据来源: WILEY

ISSN:0277-6715    

DOI:10.1002/sim.4780090102

出版商:Wiley Subscription Services, Inc., A Wiley Company    

年代:1990

数据来源: WILEY