From molecule to medicine

Roche utilises cutting-edge technologies to create numerous new chemical compounds in the laboratory by combining known elements. Each of these millions of compounds is tested to determine which has the potential to become an effective medicine. Out of many thousands of substances, only a handful remain that may prove to be promising.

Once a promising compound is discovered, researchers develop studies to assess its effect on specific biological targets. Clinical trials for new medicines are conducted in multiple phases. In the first phase, safety and tolerability are assessed in trials with healthy volunteers. Subsequently, in the second phase, the presumed efficacy of the medicine is confirmed. In the third phase, the medicine is tested in large-scale studies with many patients under realistic conditions.

Clinical trials are essential to determine the safety and efficacy of new medicines, as well as the clinical benefit of diagnostic tests. They provide crucial information on the cost-effectiveness of a treatment or diagnostic test, as well as how a treatment improves quality of life. This information is shared with regulatory authorities and payers in order to obtain market authorization and, ultimately, reimbursement.

Each year, more than 2,000 clinical trials sponsored by Roche provide patients with state-of-the-art care and free treatment.

The success of our clinical trials is fundamental to the success of our company. All Roche trials—regardless of where they are conducted—are carried out in accordance with international guidelines, including:

• The Declaration of Helsinki, a set of ethical principles developed by the World Medical Association to guide physicians and other researchers in conducting medical research involving human subjects.

• The guidelines of the International Conference on Harmonisation (ICH) and national regulations on Good Clinical Practice (GCP), which are designed to protect the rights and safety of patients.

To ensure compliance with these standards, all employees and study personnel involved in clinical trials must be trained in ICH and GCP guidelines.

Ethical Standards

Each trial must be approved by national and regional regulatory authorities, as well as by local ethics committees or independent review boards in the countries where the studies take place. These multidisciplinary committees ensure that planned studies are ethically acceptable, that participants are fully informed about benefits and risks, and that the medical staff conducting the studies takes appropriate measures to protect participants.

At every stage of a clinical trial, Roche evaluates safety and efficacy in order to determine the benefit-risk profile of the medicine. If the risk outweighs the potential benefit for patients, we adapt the study or discontinue the development of the medicine.