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Letter to Professor Chris Butler, Principle Trial requesting results

Dr Tess Lawrie writes to Professor Chris Butler requesting the interim results of the trial which as been paused due to ‘supply issues’


Dear Professor Butler

PRINCIPLE: request for interim data on “paused” ivermectin arm

We note from press reports and the PRINCIPLE website that the ivermectin “arm” of

PRINCIPLE is “currently paused due to temporary supply issues”.

We are updating our Systematic Review and Meta-Analysis of ivermectin in Covid-19

(Am. J. Therap. 28, e434-e460) and should like to request your interim results as at the

“pause” point, ideally via de-identified Individual Participant Data (IPD).

You may be aware of recent critiques of meta-analyses based on summary data only

(e.g. Lawrence et al. Nat. Med. 27(11), 1853). There is growing advocacy elsewhere for

access to de-identified IPD for all clinical trials.

Although meta-analyses based on IPD are considerably more laborious than those based

on summary data, it is clear that new standards are being called for.

As a large and visible clinical trial of ivermectin, we should like to request interim results

for the ivermectin and control arms and de-identified IPD for inclusion in our updated

Systematic Review.

Please let us know your terms and data protection requirements for release of your deidentified

IPD.

Yours sincerely

Theresa A Lawrie MB BCh PhD

EbMCsquared, Northgate House, Upper Borough Walls, Bath BA1 1RG


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