A decade of breast cancer clinical investigation: results as reported in the Program/Proceedings of the American Society of Clinical Oncology.

Chlebowski, RT; Lillington, Linda

doi:10.1200/jco.1994.12.9.1789

Cited by 28 publications

(10 citation statements)

References 13 publications

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“…Our results were similar to previous reviews of oncology RCTs [8-10,16,19-21]. Where differences exist these seem to be justified given the differences in the types of trials funded by HTA and NCI.…”

Section: Discussionsupporting

confidence: 89%

Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

Dent

Raftery

2011

Trials

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BackgroundPrevious research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios.MethodsData on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1) statistically significant in favour of the new treatment, 2) statistically significant in favour of the control treatment 3) true negative, 4) truly inconclusive, 5) inconclusive in favour of new treatment or 6) inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials.ResultsData from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not) in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%). The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative). The results were classified as truly inconclusive (i.e. failed to answer the question asked) for 24% of comparisons (20/85). HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials.ConclusionsThe pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that existed were plausible given the differences in the types of trials -HTA trials are more pragmatic. The results indicate HTA trials are compatible with equipoise. This classification usefully summarises the results from clinical trials and enables comparisons of different portfolios of trials.

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Section: Discussionsupporting

confidence: 89%

Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

Dent

Raftery

2011

Trials

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“…Chlebowski and Lillington found that 16% of trials comparing adjuvant therapies for localised breast cancer, but only 2% of trials for advanced breast cancer, favoured experimental treatment 23. We similarly found that trials for advanced solid tumours were less likely than other trials to favour experimental treatment.…”

Section: Discussionsupporting

confidence: 57%

Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis

Joffe

Harrington²,

George³

et al. 2004

BMJ

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“…An analysis of abstracts on the treatment of breast cancer submitted to a major oncology conference over 10 years showed that, although approximately 16% of randomized trials examining adjuvant chemotherapy showed a significant benefit to the experimental arm, only 2% of trials in advanced-stage disease showed a significant benefit for the experimental arm. 4 In fact, advanced-stage trials were more likely to show a significantly worse result for the experimental than the control arm, and the 2% rate of positive results was less than the expected rate of false positive trials. The point of this analysis was to show that it is difficult to perform any trial in oncology that shows a significant benefit for the new therapy-especially in settings such as advanced disease.…”

mentioning

confidence: 97%

Editorial: Perils and Pitfalls of Clinical Trials—Experience from Human Oncology

Pitson

Fyles

2000

Veterinary Internal Medicne

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A decade of breast cancer clinical investigation: results as reported in the Program/Proceedings of the American Society of Clinical Oncology.

Cited by 28 publications

References 13 publications

Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis

Editorial: Perils and Pitfalls of Clinical Trials—Experience from Human Oncology

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