Doctors and Patients Can Search for Drug-safety Information Using IFPMA Clinical Trials Portal

On September 21, 2005 the International Federation of Pharmaceutical Manufacturers and Associations ("IFPMA") established a new web site called the IFPMA Clinical Trials Portal.  This new web site is intended to provide on-line information about the results of clinical trials for new drugs being developed by drug companies around the world. 

In particular, doctors and patients could search for drug-safety information derived from the clinical trial results.  Plans for this new industry-sponsored web site, or web portal, were announced earlier in 2005.  The new web site has the support of major pharmaceutical groups such as GlaxoSmithKline Plc, Pfizer Inc., AstraZeneca Plc, Merck & Co. Inc., Novartis AG, and Sanofi-Aventis SA — some of which have already made available on-line some findings and results from clinical trials involving their new drugs.

It is widely believed that the pharmaceutical industry has created this new web site in an effort to avert legislation from various national governments that would mandate what type of clinical trial result information should be available to doctors and patients as regards new drugs and medicines.  Following the Vioxx recall and the ongoing controversy over antidepressant use in children, there has been increased criticism that the drug companies sometimes seem to manipulate or suppress results of clinical trials in order to get favorable conclusions.  In fact, however, the controversy about drug companies concealing research has been increasing for years.      

Reportedly, the new web site will carry detailed information about most new clinical trials regarding new drugs under development.  The drug companies, however, will have the option to prevent some clinical trial information from being available through the web site.

Generally, findings from Phase I (early-stage) clinical trials will not be available through the web site.  Furthermore, there is no obligation to reveal the results of any stage of the clinical-trial process before a drug is approved for patient use by government regulators.  Instead, the results from clinical trials are suppose to be available through the web site within one year of a drug’s approval or, for new clinical trials on those drugs that have already been approved for use, the results are to be available within one year of the new trial being completed.

Despite these exclusions and limitations, Richard Barker, director general of Britain’s pharmaceutical association, told Reuters that this new web site is a significant step forward in transparency.

Since the web site is dependent upon the drug companies as regards what clinical trial findings will be posted and when, the value of this new web site in terms of a drug-safety tool remains to be seen.

(Posted by: Tom Lamb)