ABPI defends members accused of withholding clinical trial data
Clinical The ABPI has claimed pharmaceutical companies are very pro-transparency in the wake of accusations that clinical trial data is being withheld
The Association of British Pharmaceutical Industry (ABPI) has defended its members against accusations it is withholding clinical trials data as it insisted the All Trials campaign was shaking people's faith in medicines.
Pharmaceutical companies were very pro-transparency already and encouraging them to make trial data available was "pushing at an open door", said ABPI director of research, medical and innovation Bina Rawel.
Bad Pharma by Ben Goldacre (pictured) could shake people's faith in medicines, the ABPI said |
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However, she hoped the ABPI's plans for additional measures to ensure companies publish data on their medical research would help restore pharmacists' faith in clinical trials, Ms Rawel told C+D. She said that the organisation had been in contact with the All Trials campaign and its spokesperson Ben Goldacre already, which were calling for the publication of all clinical trial results, to discuss what measures were needed to ensure pharmaceutical companies published details of current and past clinical trials, said Ms Rawel. |
It was sad that Mr Goldacre's book Bad Pharma could shake people's faith in their medicines, as Britain had an "incredibly strong" regulatory system, Ms Rawel added.
The ABPI is due to produce a "transparency toolkit" to raise awareness of what data pharmaceutical companies need to make public. It also planned to monitor whether companies were complying with its code of practice on clinical trial transparency, the group announced last week.
Under the ABPI code of practice, pharmaceutical companies must register medicines trials within 21 days of enrolling the first patient.
"Although guidelines were written, although people signed up, there was never a process to actually monitor compliance. So I think compliance was possibly a weak link," Ms Rawel said last week at a meeting to set out ABPI's position on the issue.
The transparency toolkit will be launched in the third quarter of the year and will include best practice guidelines, standard operating procedure templates and auditing checklists.
The toolkit was designed to help smaller companies with fewer resources and meant the industry would have no excuse to be non-compliant with the ABPI guidelines, Ms Rawel explained.
University of Birmingham lecturer in clinical pharmacy Anthony Cox welcomed the ABPI's new measures to encourage transparency, but suggested it could have gone further.
"It would be better if the ABPI signed up to the All Trials campaign, as have Nice and GSK, and help make sure that this effort to increase transparency doesn't fall short as previous industry attempts have," he told C+D.
Last month, Ben Goldacre told C+D that future generations would compare pharmaceutical companies withholding trial results to the practice of bloodletting.
Last year, the ABPI was one of a number of healthcare bodies that jointly published a set of principles on clinical trial transparency as part of the Ethical Standards in Health and Life Sciences Group.
C+D has signed up to the All Trials campaign.
What else could pharmaceutical companies do to improve transparency? Comment below or email us at [email protected] You can also find C+D on Twitter, LinkedIn and Facebook |