Patient safety in clinical trials


To ensure the effectiveness and safety of each product, we have developed a systematic process. Thanks to it, we can optimize patient safety throughout the life cycle of the product.

We cooperate with regulatory authorities, monitor reports of adverse events that have occurred in patients, and communicate our product safety activities in a manner appropriate to the recipient. Each medicine may cause side effects in some patients. Our priority is to ensure that the therapeutic benefits outweigh the risks. Read more about safety and transparency in our clinical trials

Maintaining high standards.

Our products have a well-characterized benefit-risk profile based on available safety and efficacy information. They are obtained from clinical trials on which the registration by health protection institutions is based, extensive post-registration clinical trial programmes, scientific publications, pre-clinical trial data and epidemiological publications. This information is complemented throughout the life cycle of the product by spontaneous safety reports, mainly from doctors and patients.

Why is it important to have a systematic process to ensure patient safety?

All medicines are subject to rigorous testing before they are authorised by regulatory authorities (such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) in the EU or local authorities in other countries). Before the drug is given to patients, Roche scientists carefully analyze the results of early laboratory tests, which are discussed with regulatory authorities. Maintaining high standards.

  • The drug is then subjected to a monitored evaluation process in well-planned, controlled clinical trials.
  • Controlled trials are those where a new medicine is compared with placebo or with existing medicines.
  • This is usually done by a ‘double blind’ method, which means that neither the patient nor the doctor knows what medicine is being given to the patient. This ensures error-free results.

These studies collect information on the efficacy and safety (i.e. adverse reactions) of new medicines compared to existing therapeutic options. In addition, information is collected from studies of different patient groups (e.g. young people, elderly people, people of the same sex), different doses, and the use of the medicine in combination with other medicines to determine which patients benefit most or have side effects.

How is the safety of the medicine monitored?

We have effective global systems in place to continuously monitor the safety of a medicine from the time it is evaluated in clinical trials to the end of its life cycle on the market. This process includes:

  • proactive safety management plan supported by qualified physicians who monitor general safety;
  • risk management plans assessed and approved by regulatory authorities;
  • a product recall procedure to ensure that products are recalled quickly in the event of quality or safety problems.

We also review a variety of databases, including our global database, other safety databases, and large patient databases maintained by healthcare systems, to help us identify potential safety risks. These activities include regular reviews of the published literature in the field and other publications on similar products (e.g. medicines in the same class or with the same mechanism of action).