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.
Patients receive state-of-the-art care and free treatment as participants in any of the more than 2,000 Roche-sponsored clinical trials per year. The success of our clinical trials is fundamental to the success of our business. No matter where a Roche clinical trial is conducted or who conducts it, it is essential that we carefully manage all related issues and risks to ensure that:
- the safety, well-being, legal rights and ethical concerns of those taking part is addressed
- patients who have benefited from a trial can still access treatment once the trial is complete, even although the tested product may still be awaiting regulatory approval
- products are made available in all countries where participants live once the product hais been approved
- patients have the opportunity to join as well as to opt out of clinical trials appropriate for their condition
- we publish all scientifically and clinically relevant information from clinical trials promptly, to give healthcare professionals a balanced and scientific overview of the performance of our products.
All Roche clinical studies -- no matter where they are conducted -- are managed in compliance with international guidelines, including:
- the Declaration of Helsinki, a statement of ethical principles developed by the World Medical Association to guide physicians and others involved in medical research in humans;
- the International Conference on Harmonization (ICH) and national Good Clinical Practice (GCP) guidelines, which protect patient rights and safety.
To ensure compliance with these standards, we require all staff and investigators involved in clinical trials to be trained in ICH and GCP guidelines. Our company-wide compliance assurance process ensures compliance with these requirements in all countries.
We maintain a public searchable database of clinical trials on www.roche-trials.com, which contains a clinical trial protocol registry that provides of information about our Roche-sponsored trials in patients worldwide, plus a database of key results from completed trials regardless of the outcome.
Each trial must be approved by national and/or regional regulatory authorities as well as local ethics committees or institutional review boards in the countries where a study takes place. These multi-disciplinary panels ensure that proposed trials are acceptable, that participants are fully informed about the related benefits and risks related to the trials and that the healthcare professionals who run the trials (investigational staff) take appropriate actions to protect participants from any harm.
Based on these standards and recommendations, we have developed internal policies and a global position statement on clinical research. These are made available to every employee and commit us to a comprehensive range of measures to ensure high ethical conduct.
To ensure compliance with these standards, we train, monitor and audit those involved in our clinical trials, including contract research organisations (CROs) that conduct or manage trials on our behalf. We do not perform trials in countries where we do not plan to market the medicine being tested.
During each phase of a clinical trial, 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 we will modify the study or halt development of that medicine.
We run a comprehensive internal education programme to regularly remind our employees of our values and ethical standards. This helps to ensure that our employees address ethical issues and uphold our values as part of their normal work.