NUTLEY, N.J., May 19 /PRNewswire/ -- Within a year, Roche has published more than 300 protocol and result summaries of the clinical trials run by the company. This innovative research includes at least 24 studies on breast cancer alone, 36 studies on anemia and 44 studies on Hepatitis B, C, and D. Roche's website http://www.roche-trials.com is easy to navigate and ensures patients and healthcare providers have ready access to information they need, in terms they can understand. More than 100,000 visitors from Europe, North America, Asia and throughout the world have used the Roche database to date.
Beat Widler, Roche's Global Head Clinical Quality, commented: "Roche's free public website serves patients and physicians by making relevant information easily accessible. We have invested considerable resources to create and run our twin databases and the continuous interest that we see underscores that their design matches the needs of both laymen and specialists. Roche's website on clinical trials is visited by more than 150 visitors daily and we have received more than 770 e-mail inquiries since the launch of the database in April of last year."
Direct feedback on the site has been compelling. One Icelandic patient offered "congratulat(ions) on this initiative, which is without a doubt a catalyst" and expressed hope that the Roche model would drive further transparency on clinical trials. This patient's hopes appear well-founded, as a representative of another pharmaceutical company reviewed the site and expressed how "very impressed (we are) with the work you all have done with your public clinical trial registry."
Transparency and clarity go hand-in-hand
Only three months after deciding to create an electronic clinical trial registry and results database, Roche launched http://www.roche-trials.com on April 15, 2005. The website is provided by CenterWatch. At that time, Roche expected it would take up to 18 months to complete the challenge of publishing data from more than 30 medicines, on a product by product level from a large number of global and local trials. Instead, this huge task was completed within a year and work now focuses on publishing new trials each month.
Electronic database focused on relevant information
Roche believes it is vital that researchers, physicians and patients are aware of all the relevant information from clinical trials of medical interventions so that they can review this information appropriately. Results registers and databases are the most direct approach to help fulfill the contract that sponsors and investigators have with trial subjects -- that trial results will be made available and serve the greater good of adding to scientific knowledge. Accordingly, Roche uses its twin public databases to publish summary protocol information and data from clinical trials in Phase II to IV-in other words, all trials sponsored by Roche that are often called "hypothesis testing" or "confirmatory." This information includes the so-called WHO "minimum data set" for protocols, and findings on safety and all primary efficacy endpoints for trial results. Early Phase I studies are excluded to avoid confusing healthcare providers and creating false expectations for patients suffering from serious diseases. Most medicines tested in these first human studies never progress to marketed compounds and these exploratory clinical trials generally do not generate data which are later used to support clinical claims or recommendations for use. Of course, any relevant findings are published in peer reviewed journals.
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
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.
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