• Quality Assurance
  • Ongoing

More-EUROPA

An ethical framework for generating and using patient-relevant real-world data to support regulatory decision-making.

Background / Rationale

While randomized controlled trials (RCTs) remain the mainstay in drug development, approval, and reimbursement, the potential of real-world data (RWD) to contribute to the understanding of drug effects is increasingly realized. Evidence, based on RWD – real world evidence (RWE) – can contribute significantly to the evidence to support decision-making throughout all phases of (clinical) drug development, as well as improve efficiency in the design and conduct of clinical trial programs.

Objectives

Our main objective is to gain a good overview of the factors that play a role in the ethical use of RWD.

Methodology

We will do a systematic qualitative review of literature and policies and conduct patient/stakeholder-interviews.

Expected Results / Implications / Perspectives

An ethical framework for the ‘ethics of registry data use in regulatory decision making’ will be developed outlining practice-oriented standards for consent, use and access (and issues concerning de-identification), transparency, commercialization, diversity/gender and others. The framework development will engage patient-representatives and could help inform novel policies by shedding light on the ethical tensions inherent in using registry data for regulatory decision-making

Further Information

You can find further information about the project here.