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Robert Califf ran the FDA twice — Duke's trial engine built him

Founder of the Duke Clinical Research Institute; commissioner 2016–17 and again from 2022; the evidence-infrastructure commissioner

About this entry

This is Jonathan Hare's account, with its provenance shown. The person or organization named has not yet claimed or corrected it.

Person

Who this is

In Jonathan Hare's account (S-192): he and Jack Lewin met with Califf numerous times across his commissionerships. This page awaits the email archive for the dates and substance; the Catalyst placeholder framing below preceded that account.

The public record, at web grade. A Duke cardiologist who built the Duke Clinical Research Institute into the largest academic clinical-trials organization in the world; FDA commissioner in 2016–17 and again from 2022 through the change of administration in 2025, with a Verily/Google chapter between; the American official most identified with the idea that health regulation is an evidence-infrastructure problem. In this record's network: that idea is this record's idea — the FDA pilot thread and the RNS approach exist precisely because trials, registries and adverse-event systems cannot share what they know; and the Duke seat puts him one corridor from McClellan's Duke-Margolis center.

Robert Califf — FDA Commissioner, FDA (Food & Drug Administration) — stands in the Executive Catalyst Graph's Federal Officials - Healthcare sector, the pathway running through Jack Lewin. A structural placeholder per S-101's instruction: the dossier — the exact context, dates, meetings and shared initiatives, drawn from Hare's archives — is in preparation in a dedicated research thread, so that this page, when it arrives, immediately recalls the relationship for its subject. Corrections and additions are invited now as ever: evidence@qpncatalyst.io.

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Connected from here

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Provenance

Where this came from

Everything above is a distillation. The primary source is published in full, so that any claim on this page can be walked back to what was actually said — and where the two differ, the source governs.

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What is missing, and how to fix it

This entry is deliberately incomplete. The gaps below are the things only certain people can settle — and settling one is a contribution like any other: recorded, timestamped and attributed to whoever made it.

If you were there

Correct anything wrong, add what only you know, or claim this entry as your own. Write to evidence@qpncatalyst.io and Jonathan directly (both are on the button) — a timestamped confirmation comes back with your submission attached, as your own independent record. No account, no permission, no institutional standing required.

Public contributions earn Publicity Premium; bringing others who were there earns Cascade Premium. Everything is valued retrospectively as outcomes verify, so nothing has to be priced up front.

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