Module 1: Evidence Generation – The HEOR Discipline That Doesn’t Exist

In Module 1 we establish why evidence generation has no rules or standards. We introduce the four individual traditions that have attempted to address this field and suggest a set of necessary questions that an evidence generation strategy must be able to answer.

• the four traditions – decision-theoretic, evidence synthesis, regulatory lifecycle, managerial – and their mutual isolation
• why devices, diagnostics and digital are structurally disadvantaged: no phased development, iterative product change, operator learning curves, no pivotal-trial milestone
• what an evidence generation plan is and how it differs from a gap analysis, a publication plan and a launch plan
• the three failure modes: evidence generated too late, evidence generated for nobody, evidence generated and disbelieved
• the questions that an evidence generation plan must answer

Module 2: Requirements – Who Is The Evidence For and How Will It Be Judged?

In this module we identify the decision-makers whose criteria the evidence must eventually satisfy and convert those criteria into evidentiary specifications that must be understood before any study is contemplated.

• mapping the decision landscape: regulator, HTA body, national payer, procurement, clinical adopter – and where their criteria diverge
• the EU HTA Regulation Joint Clinical Assessment, PICO scoping and residual national divergence
• early dialogue and scientific advice: EMA/HTA parallel advice, NICE advice and the thinner device pathway
• target product profiles and value propositions treated as evidentiary specifications rather than marketing artefacts
• the logical priority of identifying the decision-maker first: the evidence gap is undefined until the requirement is stated

Module 3: Diagnosis – What Evidence Exists and Where Are The Gaps? 

In Module 3 we discover how to apply the mapping methods of the evidence synthesis tradition to establish the current state of the evidence base and identify its gaps.

• the “big picture” review family: scoping reviews, mapping reviews, evidence and gap maps, and when each is appropriate
• constructing an evidence gap map: framework selection, dimensions, population and interpretation
• PRISMA-ScR and the reporting discipline that makes a diagnosis auditable rather than impressionistic
• the systematic-review-first principle and the research waste argument
• reading the map against the requirements: distinguishing absence of evidence from evidence that exists but will not be accepted

Module 4: Prioritisation – Which Evidence Gaps Are Worth Closing and In What Order?

In this module we confront the two incompatible reasons by which candidate studies are ranked and learn how to prioritise evidence generation.

• value of information (VOI) and the logic of research as investment appraisal
• rapid and heuristic VOI where no decision model exists or none can be afforded
• deliberative prioritisation: James Lind Alliance, CHNRI, Delphi and structured stakeholder ranking
• the analytic-deliberative bridge, its single demonstrated lineage and why it never became method
• prioritising under commercial constraint: sequencing, budget ceilings and the studies that will never be funded

Module 5: Design and Sequencing – What Type of Study Do We Need and When?

In Module 5 our focus is on matching study designs and data sources to a health technology’s stage of maturity and to the specific requirement each study must satisfy.

• IDEAL and IDEAL-D: staging evidence to technological maturity for devices and procedures
• choosing among RCT, pragmatic trial, registry, routine data and single-arm with external control
• registries and coordinated registry networks; MDR post-market clinical follow-up reframed as an evidence asset
• economic evidence: when to model, when to collect alongside and what a budget impact analysis can and cannot carry
• sequencing and dependency: the cost of running the right study in the wrong order

Module 6: Admissibility – Will Our Evidence Be Believed?

The acceptability of our evidence to a decision-maker is an up-front design constraint. In Module 6 we therefore learn how to design backwards from the appraisal rather than manage admissibility reactively.

• why evidence fails: not absence, but inadmissibility against a named methods guide
• real-world evidence credibility: HARPER, target trial emulation, the estimand framework, FDA and EMA positions
• appraisal and reporting standards – GRADE, CHEERS, ROBINS-I – used to anticipate criticism rather than satisfy editors
• what individual HTA bodies will and will not accept from device evidence and how to establish this in advance
• designing backwards from the appraisal: pre-registration, protocol discipline, transparency

Module 7 : Conditionality and Financing – Who Is Paying For the Evidence?

Module 7 addresses the arrangements under which access is granted while evidence is still being generated and who bears the costs and risks.

• coverage with evidence development, only-in-research, and the framework for choosing among coverage options
• managed entry, risk-sharing and outcomes-based agreements
• life-cycle HTA and research-oriented managed access
• NHS routes: Early Value Assessment, the MedTech Funding Mandate and evidence generation as a condition of adoption
• negotiating conditionality: what to concede, what to resist, and the long cost of a poorly specified condition

Module 8: Governance – How Will The Evidence Generation Plan be Kept Alive?

In our final Capstone module we will construct and document an integrated evidence generation plan and address responsibility for periodic ownership and revision of the plan.

• what the integrated evidence planning literature claims, who wrote it and why almost none of it is validated
• cross-functional ownership across clinical, regulatory, medical affairs, HEOR, market access and commercial
• triggers for revision: competitor entry, methods change, regulatory shift, disconfirming interim results
• documenting the plan so it is auditable rather than aspirational: structure, artefacts, decision log
• Capstone: building a complete evidence generation plan