Pharma industry moves to improve dissemination of clinical trials’ results

The innovative pharmaceutical industry has decided
to make clinicals trials data more widely
accessible after safety concerns over certain
high profile drugs resulted in withdrawals in 2004. 

The representative bodies of the innovative pharmaceutical
industry at the European, US, Japanese and international
levels have pledged to increase the transparency of the clinical
trials sponsored by their corporate members.

The voluntary commitment follows a series of withdrawals of
a number of high-profile drugs which has cast doubt over the safety
of drugs, especially in the US. The fast authorisation
system applied by the US’s Food and Drug Administration
was often cited as a good example for the EU when it
comes to ‘cutting red tape’, notably in the review of the EU’s
pharmaceutical legislation which was completed last year. 

One of the issues which has come to the fore in the past
few months is the pharma industry’s lack of transparency
concerning clinical data submitted with requests for
authorisations. The industry has been accused of tending
to publish positive results and hiding negative or
inconclusive data.

The pharma industry has thus committed to publishing the results
of clinical trials for drugs which have been approved for
marketing to a free, publicly accessible internet database
regardless of the outcome and within one year from the first
approval of the drug. 

In addition to completed trials, the pharma
industry undertakes to publish basic information
concerning ongoing clinical trials within 21 days of the
initiation of patient enrollment and to do so in lay
language. “By making public not just the results of trials
that have taken place – whether positive or negative – but also
information on those that are just starting, the industry has made
a major step towards achieving greater transparency,” said Brian
Ager, the Director General of EFPIA, the representative body of the
European innovative industry.

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