Challenges in conducting paediatric trials with off-patent drugs.

ABSTRACT:

Introduction

For more than two decades several initiatives have emerged to increase recruitment of paediatric patients in drug trials. While trials of newly approved drugs have successfully included paediatric patients in their drug development plan, the collection of safety and efficacy data in paediatric patients treated with off-patent drugs poses a major challenge.

Aim

This paper aims to draw attention to problems and solutions across countries in investigator-initiated trials with off-patent drugs and recommendations for improvement.

Discussion

Off-patent drugs represent a particular challenge when they are included in a paediatric trial; these trials are frequently investigator-initiated and have limited resources, off-patent drugs are used in clinical settings

SUBMITTER: Haslund-Krog SS 

PROVIDER: S-EPMC8253945 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature