Presentient in Clinical Leader: when one trial leads to rethinking them all

Clinical Leader's chief editor, Dan Schell, has published a piece on our co-founder Dan Nicolau and the observation that led to Presentient. It is worth reading, not least because, as Schell notes himself, the company is not really the story.

The story starts on a COVID ward in Oxford in the earliest weeks of the pandemic. Dan, a physician-scientist called back to the UK to help, noticed that patients with COPD and severe asthma were largely absent from the ward, when everyone expected them to fare the worst against a respiratory virus. Rather than dismissing it, he started making phone calls: to colleagues in Australia, China, Romania, the United States. The same pattern kept coming back. Many of those patients were routinely using inhaled corticosteroids.

That observation became the STOIC trial, which compared inhaled budesonide against standard care in early COVID, was stopped early once the evidence became difficult to argue with, and went on to inform treatment recommendations in several countries.
The part that stayed with him was not the drug. It was the question the trial raised about trials themselves: if a study is already telling you the answer, why wait until the end to acknowledge it? Blinding exists for good reasons, and the article is clear-eyed about the tension between rigour and speed. But most pivotal studies still follow a roadmap fixed long before the first patient enrols.

Dan took the question to Tom Coates, and the two of them, in Tom's telling, spent six months "locked in a basement trying to work out how to solve blinding". Presentient followed in 2022.

The piece also touches on the FDA's Real-Time Clinical Trials initiative and why both founders think the assumptions underpinning trial design are due to shift.

Read the full article at Clinical Leader.