Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies
This article reviews the implementation challenges to the American Society of Clinical Oncology's ethical framework for including research biopsies in oncology clinical trials. The primary challenges to implementation relate to the definitions of secondary endpoints, the scientific and regulatory framework, and the incentive structure that encourages inclusion of biopsies. Principles of research stewardship require that the clinical trials community correctly articulate the scientific goals of any research biopsies, especially those that are required for the patient to enroll on a trial and receive an investigational agent...
Source: Clinical Trials - April 24, 2024 Category: Research Authors: Laura A Levit Elizabeth Garrett-Mayer Jeffrey Peppercorn Mark J Ratain Source Type: research
Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies
This article reviews the implementation challenges to the American Society of Clinical Oncology's ethical framework for including research biopsies in oncology clinical trials. The primary challenges to implementation relate to the definitions of secondary endpoints, the scientific and regulatory framework, and the incentive structure that encourages inclusion of biopsies. Principles of research stewardship require that the clinical trials community correctly articulate the scientific goals of any research biopsies, especially those that are required for the patient to enroll on a trial and receive an investigational agent...
Source: Clinical Trials - April 24, 2024 Category: Research Authors: Laura A Levit Elizabeth Garrett-Mayer Jeffrey Peppercorn Mark J Ratain Source Type: research
Reconsidering stepped wedge cluster randomized trial designs with implementation periods: Fewer sequences or the parallel-group design with baseline and implementation periods are potentially more efficient
CONCLUSION: If a three-sequence stepped wedge design with implementation periods is being considered for a future cluster randomized trial, then a corresponding modified design using only the first and last sequences should be considered if sole focus is on efficiency. However, a parallel-group design with baseline and implementation periods and analysis of covariance-based analysis can be a practical, efficient alternative. For stepped wedge designs with implementation periods and a larger number of sequences, modified versions that remove 'middle' sequences should be considered. Due to the potential sensitivity of design...
Source: Clinical Trials - April 23, 2024 Category: Research Authors: Philip M Westgate Shawn R Nigam Abigail B Shoben Source Type: research
Reconsidering stepped wedge cluster randomized trial designs with implementation periods: Fewer sequences or the parallel-group design with baseline and implementation periods are potentially more efficient
CONCLUSION: If a three-sequence stepped wedge design with implementation periods is being considered for a future cluster randomized trial, then a corresponding modified design using only the first and last sequences should be considered if sole focus is on efficiency. However, a parallel-group design with baseline and implementation periods and analysis of covariance-based analysis can be a practical, efficient alternative. For stepped wedge designs with implementation periods and a larger number of sequences, modified versions that remove 'middle' sequences should be considered. Due to the potential sensitivity of design...
Source: Clinical Trials - April 23, 2024 Category: Research Authors: Philip M Westgate Shawn R Nigam Abigail B Shoben Source Type: research
Considerations for open-label randomized clinical trials: Design, conduct, and analysis
Clin Trials. 2024 Apr 15:17407745241244788. doi: 10.1177/17407745241244788. Online ahead of print.ABSTRACTRandomization and blinding are regarded as the most important tools to help reduce bias in clinical trial designs. Randomization is used to help guarantee that treatment arms differ systematically only by treatment assignment at baseline, and blinding is used to ensure that differences in endpoint evaluation and clinical decision-making during the trial arise only from the treatment received and not, for example, the expectation or desires of the people involved. However, given that there are times when it is not feasi...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Karen M Higgins Gregory Levin Robert Busch Source Type: research
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies
Clin Trials. 2024 Apr 15:17407745241240401. doi: 10.1177/17407745241240401. Online ahead of print.ABSTRACTIn the last few years, numerous novel designs have been proposed to improve the efficiency and accuracy of phase I trials to identify the maximum-tolerated dose (MTD) or the optimal biological dose (OBD) for noncytotoxic agents. However, the conventional 3+3 approach, known for its and poor performance, continues to be an attractive choice for many trials despite these alternative suggestions. The article seeks to underscore the importance of moving beyond the 3+3 design by highlighting a different key element in trial...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Cody Chiuzan Hakim-Moulay Dehbi Source Type: research
Evaluating treatment efficacy in hospitalized COVID-19 patients, with applications to Adaptive COVID-19 Treatment Trials
CONCLUSIONS: The proposed methods comprehensively characterize the treatment effects on the entire clinical course of a hospitalized COVID-19 patient.PMID:38618926 | DOI:10.1177/17407745241238443 (Source: Clinical Trials)
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Dan-Yu Lin Jianqiao Wang Yu Gu Donglin Zeng Source Type: research
Considerations for open-label randomized clinical trials: Design, conduct, and analysis
Clin Trials. 2024 Apr 15:17407745241244788. doi: 10.1177/17407745241244788. Online ahead of print.ABSTRACTRandomization and blinding are regarded as the most important tools to help reduce bias in clinical trial designs. Randomization is used to help guarantee that treatment arms differ systematically only by treatment assignment at baseline, and blinding is used to ensure that differences in endpoint evaluation and clinical decision-making during the trial arise only from the treatment received and not, for example, the expectation or desires of the people involved. However, given that there are times when it is not feasi...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Karen M Higgins Gregory Levin Robert Busch Source Type: research
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies
Clin Trials. 2024 Apr 15:17407745241240401. doi: 10.1177/17407745241240401. Online ahead of print.ABSTRACTIn the last few years, numerous novel designs have been proposed to improve the efficiency and accuracy of phase I trials to identify the maximum-tolerated dose (MTD) or the optimal biological dose (OBD) for noncytotoxic agents. However, the conventional 3+3 approach, known for its and poor performance, continues to be an attractive choice for many trials despite these alternative suggestions. The article seeks to underscore the importance of moving beyond the 3+3 design by highlighting a different key element in trial...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Cody Chiuzan Hakim-Moulay Dehbi Source Type: research
Evaluating treatment efficacy in hospitalized COVID-19 patients, with applications to Adaptive COVID-19 Treatment Trials
CONCLUSIONS: The proposed methods comprehensively characterize the treatment effects on the entire clinical course of a hospitalized COVID-19 patient.PMID:38618926 | DOI:10.1177/17407745241238443 (Source: Clinical Trials)
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Dan-Yu Lin Jianqiao Wang Yu Gu Donglin Zeng Source Type: research
Considerations for open-label randomized clinical trials: Design, conduct, and analysis
Clin Trials. 2024 Apr 15:17407745241244788. doi: 10.1177/17407745241244788. Online ahead of print.ABSTRACTRandomization and blinding are regarded as the most important tools to help reduce bias in clinical trial designs. Randomization is used to help guarantee that treatment arms differ systematically only by treatment assignment at baseline, and blinding is used to ensure that differences in endpoint evaluation and clinical decision-making during the trial arise only from the treatment received and not, for example, the expectation or desires of the people involved. However, given that there are times when it is not feasi...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Karen M Higgins Gregory Levin Robert Busch Source Type: research
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies
Clin Trials. 2024 Apr 15:17407745241240401. doi: 10.1177/17407745241240401. Online ahead of print.ABSTRACTIn the last few years, numerous novel designs have been proposed to improve the efficiency and accuracy of phase I trials to identify the maximum-tolerated dose (MTD) or the optimal biological dose (OBD) for noncytotoxic agents. However, the conventional 3+3 approach, known for its and poor performance, continues to be an attractive choice for many trials despite these alternative suggestions. The article seeks to underscore the importance of moving beyond the 3+3 design by highlighting a different key element in trial...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Cody Chiuzan Hakim-Moulay Dehbi Source Type: research
Evaluating treatment efficacy in hospitalized COVID-19 patients, with applications to Adaptive COVID-19 Treatment Trials
CONCLUSIONS: The proposed methods comprehensively characterize the treatment effects on the entire clinical course of a hospitalized COVID-19 patient.PMID:38618926 | DOI:10.1177/17407745241238443 (Source: Clinical Trials)
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Dan-Yu Lin Jianqiao Wang Yu Gu Donglin Zeng Source Type: research
Considerations for open-label randomized clinical trials: Design, conduct, and analysis
Clin Trials. 2024 Apr 15:17407745241244788. doi: 10.1177/17407745241244788. Online ahead of print.ABSTRACTRandomization and blinding are regarded as the most important tools to help reduce bias in clinical trial designs. Randomization is used to help guarantee that treatment arms differ systematically only by treatment assignment at baseline, and blinding is used to ensure that differences in endpoint evaluation and clinical decision-making during the trial arise only from the treatment received and not, for example, the expectation or desires of the people involved. However, given that there are times when it is not feasi...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Karen M Higgins Gregory Levin Robert Busch Source Type: research
The 3 + 3 design in dose-finding studies with small sample sizes: Pitfalls and possible remedies
Clin Trials. 2024 Apr 15:17407745241240401. doi: 10.1177/17407745241240401. Online ahead of print.ABSTRACTIn the last few years, numerous novel designs have been proposed to improve the efficiency and accuracy of phase I trials to identify the maximum-tolerated dose (MTD) or the optimal biological dose (OBD) for noncytotoxic agents. However, the conventional 3+3 approach, known for its and poor performance, continues to be an attractive choice for many trials despite these alternative suggestions. The article seeks to underscore the importance of moving beyond the 3+3 design by highlighting a different key element in trial...
Source: Clinical Trials - April 15, 2024 Category: Research Authors: Cody Chiuzan Hakim-Moulay Dehbi Source Type: research
