Perspectives in clinical research · 2025
Analyzing Subject Expert Committee meeting of minutes as a strategic metric for evaluating India's clinical research trajectory.
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.
Khan Tahir Ishrak, Jani Ashutosh, Kotla Pooja N
Аннотация
BACKGROUND: In India, the Central Drugs Standard Control Organization (CDSCO) regulates drug, device, and cosmetics to support evidence-based decisions, and the Ministry of Health and Family Welfare established Subject Expert Committees (SECs) for drug approvals and clinical trials (CTs). Initially, established as New Drug Advisory Committees with 12 panels in 2011, they were restructured as Subject Expert Committees (SECs) in 2014 and expanded to 25 panels in 2015, a COVID-19-specific SEC were introduced in April 2020 to expedite vaccine and therapeutic assessments. This study analyses four years of SECs meeting minutes to assess decision-making trends and regulatory consistency.
METHODS: A systematic review of the SECs' meeting minutes was conducted from January 1, 2018, to December 31, 2021. Applications were grouped into two categories: CTs and marketing authorization (MA), with consideration of waiver status. Each submission was further classified based on its regulatory outcome as approved, requiring modifications, or rejected.
RESULTS: Over 48 months, 551 s meetings reviewed 4563 agenda items, of which 3557 (77.95%) were evaluable, including 2170 (61.01%) CT applications and 1383 (38.88%) for MA, irrespective of a waiver request. Applications seeking a CT waiver were significantly more likely to be rejected (cOR: 10.13 [6.90, 14.87], P < 0.001), while oncology-related waivers had a higher approval likelihood (cOR: 7.18 [4.14, 12.48], P < 0.001). Variability in meeting minutes highlighted inconsistencies in decision-making and documentation across SEC panels.
CONCLUSION: Our analysis of 4563 s applications shows high approval rates, particularly in oncology, ophthalmology, and vaccines. However, inconsistencies in meeting documentation limit transparency and regulatory predictability. Standardized reporting guidelines could enhance consistency, transparency, and stakeholder confidence in regulatory decisions.
METHODS: A systematic review of the SECs' meeting minutes was conducted from January 1, 2018, to December 31, 2021. Applications were grouped into two categories: CTs and marketing authorization (MA), with consideration of waiver status. Each submission was further classified based on its regulatory outcome as approved, requiring modifications, or rejected.
RESULTS: Over 48 months, 551 s meetings reviewed 4563 agenda items, of which 3557 (77.95%) were evaluable, including 2170 (61.01%) CT applications and 1383 (38.88%) for MA, irrespective of a waiver request. Applications seeking a CT waiver were significantly more likely to be rejected (cOR: 10.13 [6.90, 14.87], P < 0.001), while oncology-related waivers had a higher approval likelihood (cOR: 7.18 [4.14, 12.48], P < 0.001). Variability in meeting minutes highlighted inconsistencies in decision-making and documentation across SEC panels.
CONCLUSION: Our analysis of 4563 s applications shows high approval rates, particularly in oncology, ophthalmology, and vaccines. However, inconsistencies in meeting documentation limit transparency and regulatory predictability. Standardized reporting guidelines could enhance consistency, transparency, and stakeholder confidence in regulatory decisions.