Media Release
Basel, 21. January 2005
Roche
to launch publicly accessible databases for clinical trials
Enhanced
transparency through electronic databases for clinical trial protocol registration and reporting of
results
Roche announced today that it is establishing a global clinical
trial protocol registry to disclose information about new Phase II to Phase IV studies at or before
their start. In addition, the company will create a global clinical trial results database for key results
from completed trials.
The new registry and results database will enable the coordination
of data Roche publishes and ensure that ultimately, there is one global source for all Roche-sponsored
clinical trial data. Both the clinical trial registry and results database, which will be hosted by
an independent, neutral entity, will be available to the public via a website by the end of the first
quarter 2005. The name of the organisation will be announced in due time.
Ed
Holdener, Head of Global Pharma Development at Roche, commented: “Transparency on the results of its
clinical studies has always been important to Roche. At the same time, it is important that we protect
the safety and the rights of patients, and secure the quality and integrity of the data and related
conclusions. Our current policy on the publication of clinical trial data will be further enhanced and
consolidated by the creation of one electronic source of information. This clear and transparent approach
is in the best interest of all parties involved.”
The Roche approach
is in accord with and even exceeds the information disclosure principles published earlier this year
by the European Federation of Pharmaceutical Industry Associations (EFPIA).
Roche
has always been dedicated to transparency in clinical trials and publishes both positive and negative
results of late stage development trials. The company is now committed to creating both a clinical trial
results database to ensure health care providers have ready access to new information and a clinical
trial registry to help patients and their physicians find clinical trials that may be appropriate for
them.
Clinical trial information will be added in a staged approach
on the results database and will ultimately include protocol information from all Phase II to Phase
IV clinical trials completed on or after October 1, 2004. In addition, data from all Phase II to Phase
IV clinical trials for products marketed on or after October 1, 2002 will be included retrospectively.
The
clinical trial protocol registry
The clinical trial registry will serve as a global
repository for information on ongoing Phase II through Phase IV clinical studies. It will contain information
in layman’s terms about each trial to inform the public, in particular patients and healthcare professionals,
as to the trial’s purpose and conditions of participation.
The
clinical trial results database
The clinical trial results database will ensure
the fair and balanced reporting of all Roche-sponsored clinical trials that might affect the practice
of medicine.
Roche will also provide links to its global registry and database in local
registries and databases, as appropriate and study results published in scientific journals will be
referenced.
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
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a
supplier of innovative products and services for the 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 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs
in prescription drug sales, while the Diagnostics Division posted sales of 7.4 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.
All trademarks used or mentioned in this release are legally protected.
Further information
- Roche and clinical trials: http://www.roche.com/sus_res_clin
- Clinical trials: http://www.roche.com/sci_events_facets_clinical
- EFPIA position statement: http://www.efpia.org/4_pos/sci_regu/Clinicaltrials2005.pdf
- Declaration of Helsinki: http://www.wma.net/e/policy/b3.htm