Clinical Trials

Clinical trials in humans are essential for confirming the safety and efficacy of new medicines, and for testing new uses for existing medicines. They are an integral part of developing new treatments for unmet medical needs. But clinical trials can involve ethical issues and risks, and their impact for the patients involved must be carefully assessed. Those responsible for planning and conducting a trial must assess whether the beneficial results of a new treatment or trial will outweigh any risks the research may carry.

The success of our clinical trials is fundamental to the success of our business. It is essential that we carefully manage all related issues and risks. We must ensure:

• That the safety, well-being, legal rights, and ethical concerns of those taking part is ensured (see Patient safety)
• That patients who have benefited from a trial can still access treatment once the trial is complete, although the product may still be awaiting regulatory approval (see Developed world access programmes)
• That products are made available in all countries where participants live once they have been approved (see R&D in developing countries)
• That medicines are not tested in vulnerable people unless they are expected to benefit from the treatment
• That patients have the opportunity to join as well as to opt out of trials appropriate for their condition
• That we publish all scientifically- and clinically-relevant information from trials promptly, to give healthcare professionals a balanced and scientific overview of the performance of our products.

Our clinical trials registry helps patients find Roche-sponsored trials that may be appropriate for them, and an online database shares the results.

At Roche, we recognise our ethical obligation to make scientifically or clinically relevant data from our clinical trials available to the public. In 2005, we created www.roche-trials.com, a website containing a clinical trial protocol registry that provides information about all our new studies with patients, plus a database of key results from completed trials.

The website is hosted by a third party to ensure impartiality. The host company, CenterWatch, is a leading web design company with experience in creating websites for clinical trial listings and results. CenterWatch is recognised as an independent source of reliable information on clinical studies. The website is written in non-technical language. It aims to:

• Help patients, in consultation with their doctors, find clinical trials that may be appropriate for their condition
• Help healthcare professionals and patients make informed treatment decisions based on a balanced overview of how our products perform in trials
• Give unrestricted public access to information on clinical trials.

We have been adding clinical trial data to the website in stages. It now includes information on all Roche-sponsored trials in patients worldwide. We are also including data from clinical trials of diagnostic products on patients. The key results of all trials are added within one year of the product receiving Health Authority approval in at least one country.

This approach is wholly consistent with the Joint Industry Position on Disclosure of Clinical Trial Information, published by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Associations (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

Information contained on the website is also available through the IFPMA Clinical Trials Portal. This is an internet search portal that provides easy, one-stop access to a variety of governmental, academic and industry Registries and Results Databases. Information on the status of all Roche trials is also published on the US National Institutes of Health website.

Our clinical trials policy describes the key features of the registry and database in more detail.