An evaluation of amendment implementation activities in an early phase clinical trials unit.
Session type: Poster / e-Poster / Silent Theatre session
Clinical trial amendments are becoming increasingly complex in early phase clinical trial settings. Operational changes triggered by amendments demand appropriate resources to maintain compliance and timely implementation.
Study amendments, implemented in the Drug Development Unit at the Royal Marsden Hospital/The Institute of Cancer Research, between January 2017 and May 2018 were reviewed retrospectively using internal study folders and trackers. Data was collected on amendment type, categorization, main changes in the amendment and operational activities required towards effective implementation.
Over 17 months, 129 amendments were implemented for 63 trials, of which 105 amendments were substantial. Eighty-five amendments were categorised as A and 44 amendments were categorised as C. Twenty-eight studies had 2 or more amendments (range 2 -8).
64% of amendments were related to Patient Information Sheet (PIS) changes and 49% were related to protocol amendments. Nearly 50% (13/24) of non-substantial amendments were related to protocol or PIS. 78% of the amendments required staff training (changes to Protocol, PIS or patient related documents) and a further 67% amendments required operational activity changes (changes to lab manual, imaging manual, pharmacy manual, enrolment criteria, patient education for diary cards and study scheduling). 29% of the amendments triggered changes to study costing template.
This is a first comprehensive review of amendment management in the UK highlighting that the management of study amendments requires significant resources at site level. The operational requirements for effective implementation of amendments are intense, demanding time and resources from study coordinator, research nurse and study physician. All protocol /PIS amendments, irrespective of their categorization, required staff training.
Study budgets must be prepared to support appropriate resource requirements for timely management of study amendments. Developing a strong working partnership between Sponsor and site, along with knowledge of operationalising amendments is essential to effective management of amendments and meet timelines.