Data we want it all and we want it now..

Data we want it all and we want it now..

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.