Assessing the current utilization status of wearable devices in clinical research
CONCLUSIONS: Our findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3 years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention the...
Source: Clinical Trials - March 15, 2024 Category: Research Authors: Takashi Miyakoshi Yoichi M Ito Source Type: research

Assessing the current utilization status of wearable devices in clinical research
CONCLUSIONS: Our findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3 years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention the...
Source: Clinical Trials - March 15, 2024 Category: Research Authors: Takashi Miyakoshi Yoichi M Ito Source Type: research

Assessing the current utilization status of wearable devices in clinical research
CONCLUSIONS: Our findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3 years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention the...
Source: Clinical Trials - March 15, 2024 Category: Research Authors: Takashi Miyakoshi Yoichi M Ito Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

A safety estimand for late phase clinical trials where the analysis period varies over the subjects
CONCLUSION: It is valuable, and possible, to use the International Council for Harmonisation estimand framework not only for efficacy but also for safety evaluation, with the estimand driven by an interpretable, and relevant, clinical question.PMID:38425019 | DOI:10.1177/17407745241230933 (Source: Clinical Trials)
Source: Clinical Trials - March 1, 2024 Category: Research Authors: Katarina Hedman Vera Lisovskaja Per Nystr öm Source Type: research

Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial
CONCLUSIONS: Targeted source data verification of data critical to trial outcomes, which carried with it a substantial time investment, did not have an impact on study outcomes in this trial. This evaluation of the cost-effectiveness of targeted source data verification contributes to the evidence-base regarding the context where reduced emphasis should be placed on source data verification as the foremost monitoring activity.PMID:38420923 | DOI:10.1177/17407745231222019 (Source: Clinical Trials)
Source: Clinical Trials - February 29, 2024 Category: Research Authors: Renate Le Marsney Kerry Johnson Jenipher Chumbes Flores Shelley Coetzer Jennifer Darvas Carmel Delzoppo Arielle Jolly Kate Masterson Claire Sherring Hannah Thomson Endrias Ergetu Patricia Gilholm Kristen S Gibbons Source Type: research

Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial
CONCLUSIONS: Targeted source data verification of data critical to trial outcomes, which carried with it a substantial time investment, did not have an impact on study outcomes in this trial. This evaluation of the cost-effectiveness of targeted source data verification contributes to the evidence-base regarding the context where reduced emphasis should be placed on source data verification as the foremost monitoring activity.PMID:38420923 | DOI:10.1177/17407745231222019 (Source: Clinical Trials)
Source: Clinical Trials - February 29, 2024 Category: Research Authors: Renate Le Marsney Kerry Johnson Jenipher Chumbes Flores Shelley Coetzer Jennifer Darvas Carmel Delzoppo Arielle Jolly Kate Masterson Claire Sherring Hannah Thomson Endrias Ergetu Patricia Gilholm Kristen S Gibbons Source Type: research