Bayer publishes clinical trial data
about its ongoing clinical trials, reinforcing the intention of the
pharmaceutical companies within the industry to provide an arena in
which they can publish information on their international and
national clinical trials.
The website closely mirrors the publicly accessible US government database that collates all the clinical trials currently being performed by the main pharmaceutical companies. Bayer's introduction of its own website signals their intentions to not only make the Bayer process of drug R&D more transparent but provide an opportunity for patients to who wish to find out more about trials concerning the diseases from which they suffer.
Bayer said that initially, information would be posted on ten trials that commenced after January 6, 2005. The database would then be constantly updated, with trials starting after July 1, 2005, being listed on the website within three weeks after commencement.
Bayer intends to list all ongoing trials on the Internet by mid-September 2005, concentrating on phase III and IV trials. In cases, such as trials in cancer and trials of major medical significance, data on phase II trials will also be made available to the public.
As of March 2006, all completed trials that started after October 1, 2002, will be listed on the Internet.
"This measure is in line with the position paper issued by the pharmaceutical associations in Europe, Japan and the United States, and the International Federation of Pharmaceutical Manufacturers and Associations," said Arthur Higgins, chairman of the BHC Executive Committee.
Bayer's website focuses on information about clinical trials, questions and answers and various links, for example to associations and organisations. The website also comprises a "Trial finder," which provides information about trial status.
Bayer said that the section, which features descriptions of the trials, has been written in a language that is comprehensible to a lay audience, providing information about the substance, indication, purpose of the trial and the conditions stipulated for participation. Visitors also have the opportunity to make trial-specific inquiries.
The Internet database is in English, as it is the intention of the pharmaceutical industry to provide a public-access database in which all companies worldwide can publish information on their international and national clinical trials.
Despite the best intentions of the pharmaceutical companies, not everybody is totally happy. A recent statement made by the members of the International Committee of Medical Journal Editors (ICMJE), highlighted that not all pharmaceutical companies were playing to the guidelines.
It stated: "Many entries in the publicly accessible clinicaltrials.gov database do not provide meaningful information in some key data fields. A search conducted on May 4, 2005 indicated that certain pharmaceutical-company entries list a meaningless phrase (e.g., "investigational drug,") in place of the actual name of the drug, even though US law requires trial registrants to provide "intervention name,"."
In September 2004, members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials.
"A complete registry of trials would be a fitting way to thank the thousands of participants who have placed themselves at risk by volunteering for clinical trials," they said.
"They deserve to know that the information that accrues from their altruism is part of the public record, where it is available to guide decisions about patient care, and deserve to know that decisions about their care rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to published."
