Media Release
Basel, 15 April 2005
Roche
clinical trial registry and results database launched on www.roche-trials.com
High
degree of transparency to enhance communication between Roche, patients and doctors
Within
only three months after deciding to create an electronic database, Roche is launching a public clinical
trial registry and results database using an independent host, CenterWatch. On www.roche-trials.com
information on Roche’s clinical trials can be accessed by anyone, anywhere, with no password restrictions.
This site is designed to give patients and healthcare providers ready access to information they need,
in terms they can understand.
Ed Holdener, Head of Global Pharma Development
at Roche, said: “We are proud to go live with our publicly accessible protocol registry and clinical
trial results database today. Transparency has always been and continues to be a priority for us. In
January, we announced our plans to have an independent host for the database and since then, we selected
CenterWatch, a company with a wealth of experience in the area of data management and the publication
of clinical trial information. So for the first time ever, there is now a global and publicly accessible
database, containing comprehensive information about Roche’s clinical trials”.
Roche
expects that the huge task of publishing data from more than 30 medicines, on a product by product level
from a large number of global and local trials, will take approximately a year. Roche will also continue
to contribute information to established databases (i.e. www.clinicaltrials.gov)
Information
that can be found in the electronic database
Starting with Fuzeon and Bondronat,
clinical trial information will be added in a staged approach on the databases and will ultimately include
protocol information and results from all Phase II to Phase IV clinical trials completed after 1 October,
2004. In addition, data from all Phase II to Phase IV clinical trials for medicines first marketed after
1 October, 2002 will be included retrospectively. The clinical trial registry and results database will
also include interventional clinical studies from Roche Diagnostics.
Roche
approach and possible industry solution
Roche is taking a leadership role in the
industry’s efforts to ensure transparency with its global approach, which is consistent with the information
disclosure principles published earlier this year by the European Federation of Pharmaceutical Industry
Associations (EFPIA).
The Roche strategy may model an industry-wide solution. Roche would
support and participate in a future industry solution that provides a public database in which all companies
can publish both national and international protocol information and trial results. Roche would be delighted
if this independent solution would lead other pharmaceutical companies to use the CenterWatch repository
to register ongoing clinical trials and report results of trials.
CenterWatch is a leader
in web design and experienced in the implementation of websites for clinical trial listings and clinical
trial results, and already has an established reputation as an independent source that the public trusts
for clinical trial listings and results. Having CenterWatch host Roche’s clinical trials databases provides
the widest possible exposure, and makes it easy for the public to obtain important information in this
area.
Strict adherence to regulations of clinical trials
Roche
works to ensure that all its activities are performed in accordance with ethical and regulatory requirements.
Moreover, Roche is strongly committed to verifying adherence to compliance policies. Adequate and ongoing
peer review is a key prerequisite for maintaining high ethical standards in Roche’s clinical trials
and development activities.
In addition, Roche adheres to the “Declaration of Helsinki”,
a statement developed by the World Medical Association on ethical principles to provide guidance to
physicians and other participants in medical research involving human subjects. Roche also strictly
follows the rules of good clinical practice (GCP), which ensure the protection of patients’ safety and
rights.
About CenterWatch
Thomson
CenterWatch (CW) is part of Thomson Healthcare and Scientific, probably best known as publishers of
the PDR (Physician's Desk Reference) and Current Drugs. Thomson Healthcare and Scientific is a division
of the Thomson Corporation, a Canadian based information services provider. For over a decade, CW has
been the leading provider of clinical trials information to healthcare professionals and the patient
community. Their market intelligence data and editorial content is highly respected among global pharmaceutical
industry professionals. They publish eight top-selling guidebooks covering training issues for today’s
clinical research professionals. In 1995 CW launched the www.centerwatch.com web
site and began publishing listings of clinical trials seeking patient volunteers. The oldest and largest
trial database on the web, the Clinical Trials Listing Service™ now lists nearly 15,000 industry-sponsored
clinical trials, as well as an additional 20,000 clinical trials sponsored by the NIH and NCI. In 2004
alone, nearly 10 million people will visit the site directly or access information through their vast
network of content partners.
About Roche
Headquartered
in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the
fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the
early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range
of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics,
the leading supplier of medicines for cancer and transplantation and a market leader in virology. In
2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics
Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous partners, including majority ownership
interests in Genentech and Chugai. Additional information about the Roche Group is available on the
Internet (www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Further information:
- Roche and clinical trials: www.roche.com/sus_res_clin
- Clinical trials: www.roche.com/sci_events_facets_clinical
- EFPIA position statement: www.efpia.org/4_pos/sci_regu/Clinicaltrials2005.pdf
- Declaration of Helsinki: www.wma.net/e/policy/b3.htm