Novo Nordisk is the latest pharmaceutical company to offer direct access through its corporate website to information on its clinical trial activities and data.
The Danish company has launched a clinical trials portal that includes a registry of Phase II to IV studies underway worldwide and results of trials for marketed Novo Nordisk products finalised after October 2002. In a parallel initiative, the company has introduced what it believes is the first website in the industry dedicated specifically to bioethics.
The new clinical trials website at www.novonordisk-trials.com is not the first time the company has made information about its studies available online. In 2005, Novo Nordisk started to publish trial results on www.ClinicalStudyResults.org and to post information about its trials on the US government registry www.clinicaltrials.gov. However, the company has followed the lead of big pharma stalwarts such as GlaxoSmithKline, Roche and Eli Lilly by setting up its own trial registry and results database.
The trial registry contains information on Phase II-IV clinical studies worldwide where Novo Nordisk has sponsor responsibility for initiating, managing and financing the trial. Phase I studies will be registered “when required by authorities and/or journal editors,” Novo Nordisk added. Despite calls from the World Health Organisation for registration of all clinical trials, industry associations and companies such as Roche have drawn the line at disclosing early-phase studies, claiming this could hamper drug development or create false expectations among patients.
20 key data points
For individual trials, the Novo Nordisk registry includes all 20 key data items for studies ongoing at, or initiated after July 1, 2005, as required by the International Committee of Medical Journal Editors. Studies will be registered no later than 21 days after the first trial participant is enrolled.
The results of clinical trials for marketed Novo Nordisk products finalised since October 2002 will be posted in accordance with the joint position announced by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) in January 2005.
This includes information on references, links to reports of the trials in peer-reviewed journals and/or a summary of the clinical trial results. Links to the approved product labelling for the US and the EU are provided on the new portal, which also offers information about Novo Nordisk’s global ethical standards and guidelines for clinical trials.
The bioethics website collates information about bioethical issues and Novo Nordisk’s positions on access to health, animal experimentation, gene technology, human rights, intellectual property rights/patenting, use of non-human primates and stem cells in the R&D section of www.novonordisk.com.
“We wanted to provide a full overview of Novo Nordisk’s approach and performance within bioethics,” said chief scientific officer Mads Krogsgaard Thomsen. “Bioethics is an integral aspect of our R&D activities.”