Risk-benefit trade-offs and precision utilities in phase I-II clinical trials
CONCLUSIONS: Herein, we first describe why it is essential to consider clinical practice when designing a clinical trial and outline a stepwise process for doing this. We then review a precision phase I-II design based on utilities tailored to prognostic subgroups that characterize efficacy-toxicity risk-benefit trade-offs. The design chooses each patient's dose to optimize their expected utility and allows patients in different prognostic subgroups to have different optimal doses. We illustrate the design with a dose-finding trial of a new therapeutic agent for metastatic clear cell renal cell carcinoma.PMID:38111231 | DO...
Source: Clinical Trials - December 19, 2023 Category: Research Authors: Pavlos Msaouel Juhee Lee Peter F Thall Source Type: research
Risk-benefit trade-offs and precision utilities in phase I-II clinical trials
CONCLUSIONS: Herein, we first describe why it is essential to consider clinical practice when designing a clinical trial and outline a stepwise process for doing this. We then review a precision phase I-II design based on utilities tailored to prognostic subgroups that characterize efficacy-toxicity risk-benefit trade-offs. The design chooses each patient's dose to optimize their expected utility and allows patients in different prognostic subgroups to have different optimal doses. We illustrate the design with a dose-finding trial of a new therapeutic agent for metastatic clear cell renal cell carcinoma.PMID:38111231 | DO...
Source: Clinical Trials - December 19, 2023 Category: Research Authors: Pavlos Msaouel Juhee Lee Peter F Thall Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022
CONCLUSIONS: Future methods development should prioritize methods for SW-CRTs with binary or time-to-event outcomes, small numbers of clusters, continuous recruitment designs, multivariate outcomes, or time-dependent repeated measures. Trialists, journal editors, and peer reviewers should be aware that SW-CRTs have additional methodological requirements over parallel arm designs including the need to account for period effects as well as complex intracluster correlations.PMID:37990575 | DOI:10.1177/17407745231208397 (Source: Clinical Trials)
Source: Clinical Trials - November 22, 2023 Category: Research Authors: Pascale Nevins Mary Ryan Kendra Davis-Plourde Yongdong Ouyang Jules Antoine Pereira Macedo Can Meng Guangyu Tong Xueqi Wang Luis Ortiz-Reyes Agn ès Caille Fan Li Monica Taljaard Source Type: research
