LUCID Workshops

How do I know my intervention is ready for testing in a definitive trial?

Professor Amanda Farrin

Background, aims and content

Guidance exists to inform the design and conduct of feasibility and pilot studies preceding definitive trials, including pre-specifying progression criteria to inform the decision to move to a definitive trial.  Progression criteria usually assess the feasibility of trial procedures, e.g. rates of recruitment, follow-up, and, sometimes, intervention delivery, or relate to key trial design estimates, such as event rates or sample size assumptions. There is, however, less guidance on determining if sufficient intervention development has been completed, in order to justify moving to a definitive RCT for intervention evaluation. 

This workshop will provide an overview of a recent paper, which introduces a novel framework for guiding the decision-making process for trial development: the Stroke Recovery and Rehabilitation Roundtable Trials Development Framework (SRRR-TDF) (Int J Stroke 2019, 14(8), 792-802).  Participants will then have the opportunity to consider how to apply or adapt the SRRR-TDF framework for different types of intervention types.  The workshop will comprise both short presentations and small-group work.

Target Group

Any researchers/academics/clinicians developing interventions and interested in learning more about how and when to proceed to a definitive trial evaluation.  No prior knowledge assumed.

** Participants should provide a brief description of the types of intervention typical in their area of research or clinical practice on registering to this workshop  **