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Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop

Autor: V G, De Gruttola, P, Clax, D L, DeMets, G J, Downing, S S, Ellenberg, L, Friedman, M H, Gail, R, Prentice, J, Wittes, S L, Zeger

Publikováno v: Controlled clinical trials. 22(5)

We report on recommendations from a National Institutes of Health Workshop on methods for evaluating the use of surrogate endpoints in clinical trials, which was attended by experts in biostatistics and clinical trials from a broad array of disease a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::bb9d73e5014e3e1ed459f22000f98171
https://pubmed.ncbi.nlm.nih.gov/11578783

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A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. Vesnarinone Trial Investigators

Autor: J N, Cohn, S O, Goldstein, B H, Greenberg, B H, Lorell, R C, Bourge, B E, Jaski, S O, Gottlieb, F, McGrew, D L, DeMets, B G, White

Publikováno v: The New England journal of medicine. 339(25)

Vesnarinone, an inotropic drug, was shown in a short-term placebo-controlled trial to improve survival markedly in patients with severe heart failure when given at a dose of 60 mg per day, but there was a trend toward an adverse effect on survival wh

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::f69755305b5f558aeadefd2dd1411688
https://pubmed.ncbi.nlm.nih.gov/10328721

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Effect of amlodipine on mode of death among patients with advanced heart failure in the PRAISE trial. Prospective Randomized Amlodipine Survival Evaluation

Autor: C M, O'Connor, P E, Carson, A B, Miller, M L, Pressler, R N, Belkin, G W, Neuberg, D J, Frid, A B, Cropp, S, Anderson, J H, Wertheimer, D L, DeMets

Publikováno v: The American journal of cardiology. 82(7)

Investigations of calcium antagonists in patients with advanced heart failure have raised concern over an increased risk of worsening heart failure and heart failure deaths. We assessed the effect of amlodipine on cause-specific mortality in such pat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::b4337471274baa72a14a5d36655340fc
https://pubmed.ncbi.nlm.nih.gov/9781971

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Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group

Autor: M, Packer, C M, O'Connor, J K, Ghali, M L, Pressler, P E, Carson, R N, Belkin, A B, Miller, G W, Neuberg, D, Frid, J H, Wertheimer, A B, Cropp, D L, DeMets

Publikováno v: The New England journal of medicine. 335(15)

Previous studies have shown that calcium-channel blockers increase morbidity and mortality in patients with chronic heart failure. We studied the effect of a new calcium-channel blocker, amlodipine, in patients with severe chronic heart failure.We ra

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::6d0f6eab06607f36fb5bc6f0b308e41c
https://pubmed.ncbi.nlm.nih.gov/9091790

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Group sequential comparison of changes: ad-hoc versus more exact method

Autor: J W, Lee, D L, DeMets

Publikováno v: Biometrics. 51(1)

There are many clinical trials in which we are interested in comparing changes in responses between two treatment groups sequentially. Investigators might assume a simple linear model, take the average of the ordinary least square estimators of slope

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https://pubmed.ncbi.nlm.nih.gov/7766776

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Insights from monitoring the CPCRA didanosine/zalcitabine trial. Terry Beirn Community Programs for Clinical Research on AIDS

Autor: T R, Fleming, J D, Neaton, A, Goldman, D L, DeMets, C, Launer, J, Korvick, D, Abrams

Publikováno v: Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association. 10

The design, conduct, and analysis of clinical trials that evaluate the safety and efficacy of treatment interventions in patients with HIV infection provide many scientific challenges. A recently completed randomized trial of didanosine (ddI) and zal

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::cff1546e012821b74c4b95779e0aec2c
https://pubmed.ncbi.nlm.nih.gov/7552519

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