CLINICAL EVIDENCE
Developing International Standards for IVD Performance Evaluation
The Challenge
Regulatory authorities updated their requirements for manufacturers to demonstrate that diagnostics will have good performance in clinical practice. Good practice for generating data gathered in patients is well established for drugs, but is less established for diagnostics. The lack of international guidance for diagnostics performance evaluation is a barrier to efficient development and introduction of new diagnostics in clinical practice.
Our Focus
WP1 strengthens the foundations of diagnostic regulation by improving how regulatory evidence is developed, structured, and justified.
We will:
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Evaluate the need for development of an international standard for diagnostic performance.
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Propose our leadership in a collaborative initiative for a new standard within the international standards organisation ISO.
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Develop a draft document to guide state of the art methods for performance evaluation of diagnostics.
Why It Matters
Clearer, evidence-led standards for evaluation supports better regulatory decisions, reduces unnecessary delays, and gives innovators confidence about what is required.
What Success Looks Like
Advancing agreement on international standards on scientific evidence required to evaluate performance of diagnostics. An international standard will harmonise evidence requirements, cut duplication, and support faster, more consistent regulatory decisions – improving efficiency for manufacturers and access for patients.