The Health Research Authority is facing a judicial review over its work to further clinical trial transparency, the Guardian reported today. The judicial review was launched in March by Richmond Pharmacology Ltd, a contract research organisation that runs clinical trials on behalf of pharmaceutical companies.
The Health Research Authority (HRA) is a UK body set up to protect and promote the interests of patients and the public in health research in the UK. It has been working to make clinical trials more transparent: In September 2013 the HRA made registration of a clinical trial a condition of approval to run that trial and in April this year they started asking researchers applying to run a clinical trial to declare that all past clinical trials they ran have been registered. If the decision in the judicial review goes against it, this fantastic work could be overturned.
Síle Lane, Director of Campaigns, Sense About Science, co-founding organisation of the AllTrials campaign said:
“It is shocking that a company is using court action to try to stop transparency. Hidden and unregistered trials are compromising patient care, and, rightly, causing public outrage. The HRA has really led the way with its proposals to check that clinical trials aren’t kept hidden during the trial approval process. Hundreds of members of the public, patients, researchers, doctors and pharmacists have told the HRA that this is exactly what it should be doing. They want the HRA to help right the injustice done to the thousands of patients who have taken part in clinical trials that have been kept hidden. I find it deplorable that one company is trying to stop that.”
At every stage the HRA has consulted widely on its proposals and received overwhelmingly positive support. Read this summary of responses to its consultations for strong and moving words from members of the public, patients, doctors, pharmacists and researchers on why they want the HRA to work to increase clinical trial reporting.
In February 2013, HRA joined AllTrials saying: “Health Research Authority and National Research Ethics Service, now part of the HRA, have long endorsed the registration of research and subsequent publication of research results. We are delighted to sign up to the petition, which is entirely consistent with our remit to protect and promote the interests of patients and the public in health research.”
In May 2013, HRA launched a discussion paper and sought public feedback on its plans to promote transparency.
In July 2013, HRA announced that its consultation showed widespread support for its plans and would begin implementing them.
On 30th September 2013, HRA made registration of clinical trials in a publicly accessible database a condition for favourable ethics opinion for new clinical trials.
In summer 2014, HRA began publishing the research summaries approved by ethics committees.
During August and September 2014, HRA asked for comments on proposals to require trial sponsors to make a declaration that all trials approved since September 2013 have been registered. It received almost 200 responses.
Starting 30th September 2014, trial sponsors were required to make a declaration that all clinical trials approved by a NHS research ethics committee (REC) since September 2013 have been registered.
In October 2014, HRA published the results of its consultation on next steps showing overwhelming support for its work. Only one company suggested greater transparency would have no benefit for the public or patients.
On 1st April 2015 it further updated the sponsor declaration to ask researchers applying to run a clinical trial to declare that all their clinical trials in active recruitment in the UK have been registered, including those that were approved before September 2013.