Safe and transparent Clinical trials

Clinical trials are critical for determining the safety and efficacy of new medicines and the clinical value of diagnostic tests. They also provide critical information on the cost-effectiveness of a treatment or diagnostic test and how a treatment improves quality of life. This information is shared with regulatory authorities and payers in order to gain marketing approval and, ultimately, reimbursement. Roche also publishes the results of our clinical trials through numerous channels as we recognise that healthcare professionals, researchers, patients and the public are also interested in knowing about potential new therapies under development.

In 2012 over 320,000 patients in over 35,000 participating medical centres received state-of-the-art care and free treatment as participants in Roche-sponsored clinical trials.

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
• 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
• That products are made available in all countries where participants live once they have been approved
• 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.

Please see Ethics in R&D for further information.

Roche places a  high priority on communicating information about studies that are currently enroling as well as on ensuring that clincial trial results for completed studies are publicly available to physicians and other interested parties.

We maintain a searchable database of clinical trials on www.roche-trials.com, which contains a clinical trial protocol registry that provides information about all our Roche-sponsored trials in patients worldwide, plus a database of key results from completed trials regardless of the outcome.

Summarized results of all Roche and Genentech phase I-IV clinical trials, observational studies, as well as applicable diagnostics trials are added within one year of the last subject last visit for the primary outcome, or the last subject last visit for the overall study, whichever occurs first. The aim of these postings is 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.

Details of Roche clinical trials are also posted on the US National Institutes of Health global registry Clinicaltrials.gov and are available through the International Federation of Pharmaceutical Manufacturers and Associations clinical trials portal.

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).

Roche further ensures sharing of clinical data by encouraging its scientists to publish results of their work in medical journals and to present them at scientific and medical congresses.

Please see our clinical trials policy (Clinical Trial Publication Policy) for more detail.