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For health tech to thrive, don’t keep the evidence under wraps

Medical innovations now being developed could be transformative, but to safeguard consumers, test results must be out in the open

Elizabeth-Holmes

THE age of “” is upon us – in case you hadn’t noticed. Work that could transform healthcare is under way, yet the results don’t appear in peer-reviewed journals.

This issue has been brought to the fore by the case of Silicon Valley biotech firm . Its consumer blood test, combined with innovative lab technology, promise fast, accurate results relevant to dozens of illnesses, using pinprick samples, and at low cost.

Not so long ago, I warmly applauded Theranos for seeking clearance from the US Food and Drug Administration for its proprietary diagnostic tests, but cautioned that FDA clearance alone is not enough to protect consumers. Fast-forward to mid-October, when the Wall Street Journal ran an investigation with multiple anecdotal examples of potential issues with the company’s technology. Theranos has rebutted these, via its lawyers and in statements to the media.

But what about the science? I have long advocated that all medical research be transparent. If tests rely on a new technology, we need to know it works. That’s why I have favoured large-scale randomised trials for health-related interventions, testing by publicly funded stakeholders with no vested interests, improved peer review, thorough publication of findings, and the sharing of protocols and data sets.

Such measures will ultimately benefit innovators: strong evidence buttresses disruptive technologies, and makes a better case than any advert could.

“Strong evidence supports disruptive technologies and makes a better case than any advert could”

Given that health-related technology is ultimately about life-and-death situations, drugs have to prove their worth in randomised trials. For other aspects of healthcare, including lab testing, standards of evidence are lower. Laboratories can get accreditation, but for new technologies this is not enough.

èƵs need to know how a technology works and why it has advantages or disadvantages over existing ones. They need to see all the evidence. I trust in innovation, and perhaps Theranos will change the medical world. But first of all .