Clinical Trials

Clinical trials 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
• 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.

All clinical studies in Roche are conducted in compliance with international guidelines according to Good Clinical Practice (GCP) and must be approved by regulatory authorities and Ethics Committees or local Institutional Review Boards. These boards ensure that proposed trials are acceptable, that participants are fully informed about the benefits and risks related to the trials and that the healthcare professionals who run the trials (called investigators) take appropriate actions to protect patients from any harm.

During each phase of the clinical trials for a medicine, Roche’s Global Drug Safety Department evaluates the safety and effectiveness to determine the benefit–risk profile of the medicine. If the risk exceeds the patient benefit, then Roche will change the study or halt development of that medicine.

Roche makes data from patient trials publicly available via the online clinical trial protocol registry and trial results database.

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 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.