Planning and generating evidence is required from early development and continues in to post-marketing. Below is a flavour of the type of evidence that is typically required (not exhaustive)

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Evidence requirements: 

For payers  (NICE, IQWIG etc)

• Value (health economics, cost-effectiveness, budget impact, burden of illness)

• Patient impact (outcomes, PRO, QoL & utility)

For Health authorities (EMA, MHRA, FDA)

• Benefit-risk assessment: evidence accumulates and new products have to demonstrate a positive benefit-risk balance. Involve monitoring safety and effectiveness (reporting in PBRER), post-approval commitments (PASS, PAES, other epidemiological studies), implementation and evaluation of risk minimisation interventions, qualitative and quantitative BRA (models, see benefits and risks page)

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Prior to clinical development: what is the current unmet medical need (including incidence/prevalence) including standard of care (competitive landscape)? what would be the impact of introducing an effective therapy? What is the primary endpoint for subsequent clinical trials (measurable and accurate)? What are the potential safety concerns? 

During clinical development: what evidence is required over the 3 phases? what regulatory requirements need to be met? how to handle the accumulation of evidence and will it lead to a conclusion of a positive benefit-risk balance (i.e., guide regulatory submission)?

Post-approval: Benefit-risk assessment tasks, evaluation of further indications

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