UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination.

ABSTRACT:

Background/aims

Clinical trials provide an opportunity to identify new treatments and can offer patients access to treatments otherwise unavailable. However, approximately 10% of paediatric clinical trials discontinue before the trial has completed. If this premature termination is because the trial treatment(s) being investigated are identified to be ineffective or unsafe, it results in the abrupt discontinuation of the investigational medicinal product for participants. For some participants, there may not be other treatment options to pursue at the trial-end. Trials prematurely terminating can be a distressing experience for all involved and currently there is little published evidence about the guidance provided to healthcare professionals in the event of premature trial termin

SUBMITTER: Pluess-Hall H 

PROVIDER: S-EPMC11986081 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature