Pharma will have to disclose every trial undertaken
pharmafile | November 12, 2009 | News story | Sales and Marketing | IFPMA, ethics
A new international code of conduct has been issued requiring pharma firms to disclose every clinical trial they undertake.
The measure is contained in updated guidance from the Council of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
What it calls a “joint position on the disclosure of clinical trial information via clinical trial registries and databases” will come into force in six months’ time.
The Geneva-based organisation says this extends the range of trials that member companies must provide information on “to include all clinical trials in patients, as a minimum”.
This includes early-stage safety trials of medicines for life-threatening conditions, which were not covered by the guidance adopted a year ago by IFPMA.
Its membership comprises 25 international pharma companies – including AstraZeneca, Bristol-MyersSquibb, Johnson & Johnson and Pfizer. Once the new guidance comes into force they will have to post details of all new trials on a publicly accessible website within 21 days of the start of patient enrollment.
“This new joint position will provide increased clinical trial transparency for the benefit of patients and medical professionals,” said Haruo Naito, Eisai chief executive and IFPMA president.
Members should also post summary results of any trial within a year of the brand involved being approved and made commercially available in any country.
In addition to pharma companies, IFPMA’s membership includes more than 40 national and regional industry associations.
The organisation’s new stance has the blessing of industry associations for Europe (EFPIA), the US (PhRMA) and the Japanese Pharmaceutical Manufacturers’ Association.
The first joint position the three bodies adopted was one designed to facilitate greater transparency for patients, which was established in January 2005.
IFPMA launched its own clinical trials portal later that year, on which users can search for information about trials.
It recently added a facility called myPortal, which allows users to request email alerts when trials are posted which correspond to their own criteria.
In a separate development, IFPMA has also made Eduardo Pisani its new director general.
Currently vice-president, international policy and government affairs for Bristol-Myers Squibb, he takes over in January.
He succeeds Michael Boyd, who joins Pfizer in January as vice president, public affairs, biopharmaceuticals.
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