INCEPT will adhere to appropriate Danish laws regulations, the Helsinki Declaration, and the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) guidelines.
Appropriate patient consent will be obtained before inclusion in the platform trial; as critically ill patients admitted to the intensive care unit are generally temporarily incompetent, we will adhere to the Danish regulations for deferred consent by independent trial guardians and next of kin until patients are able to provide informed consent themselves.
We aim to pro-active involveme the Health Ministry, the Danish Medicines Agency, the Good Clinical Practice (GCP) units and the Danish Regions early in the progress.
The challenges of conducting a pragmatic platform trial embedded in clinical practice adhering to relevant legal and ethical frameworks, which are mostly developed for industry-initiated trials of new drugs and interventions, will be handled.
Through surveys and interviews with patients, relatives, clinicians and other stakeholders we will assess acceptance and preferences for involvement in trial design (e.g. co-enrolment, number of interventions), choice of interventions (prioritisation), choice of outcome measures (quality, quantity and ranking) and trial conduct (e.g., timing and mode of consent and follow-up).