Plans to promote participant retention and complete follow-up {18b}
The coordinating investigator of each trial will work with the trial sponsors and investigators to ensure subject enrolment and retention. Measures to minimise the patient withdrawal rate include careful patient selection, appropriate explanation of the trial requirements and procedures prior to first administration of trial medication and explanation of the differences between trial medication discontinuation and withdrawal of consent. If a patient has an AE that is judged by an investigator to be treatment-related, treatment can be interrupted or the dose can be reduced providing that the patient has completed the dose-escalation period.