Thread by @VincentRK

This thread will be an unpleasant reality check.

COVID in USA:
>2 million cases
Only 6 randomized trials (RCT) funded by NIH.
Accrual plan: 2500 patients.

What moral authority do we have to rebuke the UK NHS how they report or act on a 11500 person RCT which NHS funded?

In a country one-fifth the size, UK funded & enrolled 5 times more patients with COVID in RCTs than USA plans to accrue in a year.

RECOVERY trial compared usual care to antiviral, Dex, & HCQ

It found Dex saves lives. They did the right thing for citizens that funded the trial

I have been in this situation before, and this was absolutely the right call. We make this call frequently in oncology. People should look up history.

But that’s not the point of this thread. The point is the dismal investment we have in NIH funded randomized trials in the US.

For 2 million persons with COVID we have 6 publicly funded trials with a total planned accrual of ~2500.

2 of these test HCQ
2 remdesivir (with one arm baricitinib)
1 Tocilizumab

How are we planning to find best treatments to save lives with minimal investment in RCTs?

I have led & published 10 RCTs. 5 of these were publicly funded. 5 funded by Pharma.

To initiate & complete a publicly funded trial was worse than pulling teeth. It’s a miracle we succeed.

We need a massive increase in investment in publicly funded RCTs, & reform the process

Pharma RCTs give us new drugs. I’m proud to work with Pharma. I will continue to do so. But there are important questions for clinical practice that Pharma will not test. It’s simply too risky— we may find their drug doesn’t work. That’s why we have the NIH funded mechanism

From a severe lack of resources and funds, to a process that makes young investigators totally demoralized — we have a major problem in conducting randomized trials like the RECOVERY trial in the US.

We need to change this.

COVID is the challenge that we should view as an opportunity to invest and reform the publicly funded clinical trial system in America

It’s also important to be humble and not preach to other countries and their investigators how to release RCT results

There is one more unpleasant reality. At least in oncology.

Most randomized trials that lead to new drug approvals by FDA have hardly any American patients. Worse still they have <3% blacks. This is unacceptable coz the effects of a drug and the side effects can vary by race

Only publicly funded trials can ensure trials have a population demographics that resembles the US population.

Otherwise we are taking bigger risks than the ones we claim may happen if we change practice based on press release.