Data we want it all
Dr. John Campbell
And we want it now.
Covid-19 vaccines and treatments: we must have raw data, now
https://www.bmj.com/content/376/bmj.o102
Data should be fully and immediately available for public scrutiny
2009 - 2012
https://clinicaltrials.gov/ct2/show/N...
Governments spent billions stockpiling Tamiflu
Majority of trials sponsored by manufacturer
Papers ghostwritten, paid by the manufacturer
Academics who requested access to the data for independent analysis were denied
Godlee F. We want raw data, now. BMJ2009;339:b5405doi:10.1136/bmj.b5405.
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Godlee F, Clarke M Why don’t we have all the evidence on oseltamivir?BMJ2009;339:b5351.doi:10.1136/bmj.b5351 pmid:19995815
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Cohen D Complications: tracking down the data on oseltamivir. BMJ2009;339:b5387.doi:10.1136/bmj.b5387 pmid:19995818
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Doshi P Neuraminidase inhibitors—the story behind the Cochrane review. BMJ2009;339:b5164.doi:10.1136/bmj.b5164 pmid:19995813
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Today
Despite the global rollout of covid-19 vaccines and treatments,
the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public
This is morally indefensible for all trials, but especially for those involving major public health interventions.
Pfizer’s pivotal covid vaccine trial, designed, run, analysed, and authored by Pfizer employees.
The company and the contract research organisations that carried out the trial hold all the data.
Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, (NCT04368728).
Moderna data
may be available … with publication of the final study results in 2022
Datasets will be available upon request and subject to review once the trial is complete
Eestimated primary completion date 27 October 2022 (NCT04470427).
AstraZeneca
As of 31 December 2021
timelines vary per request and can take up to a year upon full submission of the request
Regeneron’s phase III trial of monoclonal antibody therapy REGEN-COV
Participant level data will not be made available to others EMU)
Should the drug be approved, sharing will be considered
Remdesivir
US National Institutes of Health, (funders) The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives
In our view, there is no dilemma
the anonymised individual participant data from clinical trials must be made available for independent scrutiny.
US Food and Drug Administration, freedom of information request to the agency for Pfizer’s vaccine data
UK, Medicines and Healthcare Products Regulatory Agency
does not proactively release clinical trial documents
Transparency and trust
Transparent decision making is essential.
At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars
The BMJ supports vaccination policies based on sound evidence.
The same applies to treatments for covid-19
Data must be available when trial results are announced, published, or used to justify regulatory decisions.
There is no place for wholesale exemptions from good practice during a pandemic.
The public
Has paid for covid-19 vaccines through vast public funding of research
that takes on the balance of benefits and harms
has a right and entitlement to those data, as well as to the interrogation of those data by experts.
Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.
The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further;
it is to protect the health of their populations.
We need complete data transparency for all studies, we need it in the public interest, and we need it now.
