An evaluation of amendment implementation activities in an early phase clinical trials unit.


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Bindumalini Rao Baikady1,Satyanarayana Seeramreddi2,Dimitrios Magkos2,Sasha Gayle2,Mahesha Ganegoda2,Udai Banerji2,Johann de Bono2,Juanita Lopez3,Anna Minchom3,Praradchaya Lamb2
1The Institute Of Cancer Research,2The Institute Of Cancer Research and The Royal Marsden NHS Foundation Trust,3The Royal Marsden NHS Foundation Trust and The Institute Of Cancer Research

Abstract

Background

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.

Method

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.

Results

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.

Conclusion

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.