Journal of the neurological sciences · 2025
Factors influencing timeliness of reporting results from multiple sclerosis related clinical trials to ClinicalTrials.gov.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Cwajna Mark, Hamouda Abdelrahman M, Kendall Nicholas, Ghozy Sherief, Atieh Fatima, Aboseif Albert, Ahmed Nada S, Kallmes David F, Arumaithurai Kogulavadanan, Abboud Hesham, Flanagan Eoin P
Аннотация
INTRODUCTION: Timely reporting of clinical trial results is both an ethical obligation and a legal requirement under Section 801 of the Food and Drug Administration Amendments Act (FDAAA). The law mandates that results from applicable clinical trials be submitted to ClinicalTrials.gov within 12 months of the study's primary completion date. We examined reporting compliance among multiple sclerosis (MS)-related randomized controlled trials registered on ClinicalTrials.gov.
METHODS: Using a previously validated algorithm, we identified highly likely applicable clinical trials (HLACTs) related to MS that were completed or terminated between January 2008 and June 2023. Trial characteristics were extracted, and reporting timeliness was analyzed using Kaplan-Meier estimates, logistic regression (12-month reporting), and Cox regression (5-year reporting).
RESULTS: Among 298 eligible trials, 64 (21.5 %) reported results within 12 months, while 268 (89.9 %) reported within five years. The reporting half-life was 18 months. Phase 1 and Phase 2 trials were more likely than Phase 4 trials to report within 12 months (OR 5.61, 95 % CI 1.43-23.82; p = 0.015). In contrast, Phase 2 trials were less likely than Phase 4 trials to report within five years (HR 0.57, 95 % CI 0.36-0.89; p = 0.013). Other characteristics, including funding source, intervention type, and enrollment, were not significantly associated with reporting timeliness.
CONCLUSION: Only a minority of MS trials complied with the mandated 12-month reporting deadline, although nearly 90 % reported within five years. Phase-specific differences in compliance highlight potential areas for improvement in trial transparency. These findings may inform future efforts to promote timely reporting, though further research is needed before direct policy implications can be drawn.
METHODS: Using a previously validated algorithm, we identified highly likely applicable clinical trials (HLACTs) related to MS that were completed or terminated between January 2008 and June 2023. Trial characteristics were extracted, and reporting timeliness was analyzed using Kaplan-Meier estimates, logistic regression (12-month reporting), and Cox regression (5-year reporting).
RESULTS: Among 298 eligible trials, 64 (21.5 %) reported results within 12 months, while 268 (89.9 %) reported within five years. The reporting half-life was 18 months. Phase 1 and Phase 2 trials were more likely than Phase 4 trials to report within 12 months (OR 5.61, 95 % CI 1.43-23.82; p = 0.015). In contrast, Phase 2 trials were less likely than Phase 4 trials to report within five years (HR 0.57, 95 % CI 0.36-0.89; p = 0.013). Other characteristics, including funding source, intervention type, and enrollment, were not significantly associated with reporting timeliness.
CONCLUSION: Only a minority of MS trials complied with the mandated 12-month reporting deadline, although nearly 90 % reported within five years. Phase-specific differences in compliance highlight potential areas for improvement in trial transparency. These findings may inform future efforts to promote timely reporting, though further research is needed before direct policy implications can be drawn.