Summary
This article discusses the reasons and procedures for participant and investigator-initiated discontinuation of treatment or full withdrawal of consent in clinical trials, emphasizing continued participant follow-up.
Treatment Discontinuation in Clinical Trials
Highlights
Reasons for Discontinuation
Treatment discontinuation can be initiated by either the investigator or the participant, and can be either temporary or permanent. Participants have the right to discontinue their investigational medicinal product (IMP) or completely withdraw their consent from trial participation at any point during the study.
Continued Participant Follow-up
Even if participants discontinue the IMP, significant efforts should be made to encourage them to continue participating in the trial, attending scheduled visits and assessments. More detailed information can be found in section 3.3.4 of the protocol.