Titlebook: Cancer Clinical Trials; A Critical Appraisal Hans Scheurlen,Richard Kay,Michael Baum Conference proceedings 1988 Springer-Verlag Berlin Hei

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The Use of Data Bases and Historical Controls in Treatment Comparisonsic suggested by the title they assigned to me. They were aware that I have been an outspoken critic of the idea that data bases and historical control groups can be used reliably to compare treatments. Since I have already presented my ideas in writing several times, I will merely summarize them bri

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Limitations and Advantages of Meta-analysis in Clinical Trialsran and Welt- man 1985). By meta-analysis we mean a quantitative synthesis of data across several different but related studies. This usually entails the application of uniform methods of statistical analyses and/or data presentation. Reasons for performing a meta-analysis include confirmation of a

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Overview of Adjuvant Radiotherapy for Breast Cancert radiotherapy are updated and analyzed collectively. Briefly, these overviews, which were based on individual patient data for over 10000 patients with more than 6000 deaths, showed conclusively that radiotherapy had no appreciable affect on mortality in the first 5–10 years of follow-up, but they

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Overview of Randomized Trials of Postoperative Adjuvant Radiotherapy in Breast Cancere then, a large number of trials have addressed this issue, but the impact of this treatment on long-term survival still remains clouded. This is due partly to the long natural history of breast cancer and partly to the changing approach to primary treatment, where a trend toward less surgery and mo

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Combining Randomized and Nonrandomized Patients in the Statistical Analysis of Clinical Trialss internal validity since the treatment groups are randomly selected. The trial may not be of practical use, however, unless it also has external validity. The patients who are studied in the trial are only a small portion of the patients who satisfy the trial entry criterion. Eligible patients may

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The Comprehensive Cohort Study: The Use of Registry Data to Confirm and Extend a Randomized Trial that the patients in the trial are not representative of all patients who could be treated. Thus, the trial results may be unbiased but not generalizable. A means of verifying the external validity of the trial is given by the comprehensive cohort study design (Olschewski and Scheurlen 1985). In th

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Treatment Decisions in Breast Cancer in the extent of mastectomy for early breast cancer. A 1983 questionnaire (Gazet et al. 1985) to British surgeons about their treatment of primary breast cancer reported no consensus in respect of primary surgery, pattern of referral for postoperative radiotherapy or the use of adjuvant systemic tr

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The Crooked Path Toward the Objectivation of Therapeutic Experiencenderstand our present situation, it might be helpful to survey the historical development of clinical trials and to consider what was the basis for decisions in therapeutics before, or still is concomitant with, the introduction of such clinical trials.

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Strategies for Subgroup Analysis in Clinical Trialsdividual (or comparisonwise) . value. In a clinical trial multiple comparisons occur when analyses are repeated at several points in time, when pairwise comparisons are made among more than two treatment groups, when there is more than one end point being tested, or when the same hypothesis is tested on different subgroups of patients.