April – May, 2023
About the Course
At every stage in drug development, decisions must be made notwithstanding that data regarding a compound's effectiveness and safety are severely limited. This is particularly true when deciding whether to progress to Phase 3 and, if so, with what dose, patient group and trial design. Assurance calculations such as the Probability of Success (PoS) have become recognised as important inputs to such decisions. PoS depends on the probability distribution of the drug's treatment effect in the proposed trial(s). There is rarely any trial evidence for this using the same formulation, dose, patient group and outcome, but the development team, colleagues in the same therapeutic area and others have substantial relevant expertise and knowledge.
Expert knowledge elicitation is a formal and rigorous process that can draw these elements together, to deliver the required probability distribution of the treatment effect.
The Sheffield Elicitation Framework (SHELF) is one of a small number of leading protocols for expert knowledge elicitation. SHELF is characterised by bringing experts together to share and debate the evidence and their opinions, in order to deliver a distribution that reflects a synthesis of knowledge and expert judgement.
The four sessions in this course provide an introduction to expert knowledge elicitation using SHELF, with emphasis on what is involved in implementing the protocol and the key role of the facilitator. Through a series of case studies, they will also show the versatility of SHELF to provide far more than a single distribution for a treatment effect.
Learning outcomes: the elements of expert knowledge elicitation; the challenges to good elicitation; the SHELF protocol and how it addresses those challenges; the importance of preparation; the roles of facilitator and recorder; uses and benefits in the pharmaceutical sector.
No prior training in statistics is required to follow this course.
Who Should Attend
-
Leaders and managers in any therapeutic area will need to know what is involved in elicitation, the resource levels it requires, the benefits it can give and how to interpret the results.
-
Development team members in any therapeutic area will need to be able to act as experts in an elicitation and to have confidence that the process is rigorous and fair.
-
Core skills personnel, particularly central biostatisticians, will need to be able to set up an elicitation and to participate as facilitators or recorders. The course will provide a foundation for these people, but further training will typically be required.