The Clinical Trials Facilitation and Coordination Group has drawn up a document that provides recommendations for sponsors regarding the authorization and conduct of complex clinical trial from a current perspective.
In this document, a complex clinical trial is considered to have a complex clinical trial design if it has separate parts that could constitute individual clinical trials and/or is characterized by extensive prospective adaptations such as planned additions of new Investigational Medicinal Products (IMP) or new target populations. These separate parts will be designated “sub-protocols” or different study cohorts and arms, depending on the context. Another option is carrying out several studies with a common master protocol between them. Examples of complex clinical trial designs are basket (one IMP or combination in several populations), umbrella (several IMPs or combinations in a single population) and platform trials (several IMPs or combinations in several populations).
The CTFG has stablished key recommendations regarding design, scientific integrity, quality of trial conduct, clinical feasibility, safety, data integrity, benefit-risk balance and data transparency, among others.