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 our preclinical studies (before moving to human studies), which are discussed with regulatory authorities. The drug is then subjected to a lengthy evaluation process in well-planned, controlled clinical trials. Read more on our website dedicated exclusively to clinical trials.
What are the benefits of clinical trials?
Clinical trials are crucial for determining the safety and efficacy of new drugs, and the clinical value of diagnostic tests. They also help to determine the cost-effectiveness of a given medicine or diagnostic test and the impact of treatment on improving quality of life. Roche attaches great importance to disseminating information about the trials for which it is recruiting, as well as to ensuring that the results of completed clinical trials are publicly available to doctors and other interested parties.
We share information about sponsored trials in the clinical trial protocol registry, which also contains a database of the most important results of completed studies regardless of their outcome.
This information is made available to regulators and payers in order to obtain a marketing authorisation and, finally, a refund. In addition, we publish the results of our clinical trials-both positive and negative-in a variety of medical and specialist journals to provide healthcare professionals, researchers, patients and the public with information about potential new therapies being developed.
Learning from the various difficulties, researchers are still looking for ways to improve the clinical trial process to accelerate the delivery of safe and effective new medicines to patients and foster innovation.
Each year, approximately 100,000 patients participate in our clinical trials. 320,000 people worldwide, in more than 35,000 medical centers, where participants receive standard treatment and potential access to our experimental drugs.
How are the benefits and risks assessed?
A potential new drug is undergoing a thorough research process. Thanks to carefully and correctly planned clinical trials, information on the effectiveness and safety of a new drug is obtained and evaluated.
In the different phases of clinical trials, the safety of the drug is thoroughly studied, taking into account all emerging data, by a number of multidisciplinary teams. Their role is to assess the overall efficacy and safety of the product, i.e. to establish a benefit-risk profile.
How do we know that the results of clinical trials are reliable?
In a controlled trial, the new medicine is compared with placebo or with existing medicines. These tests are usually carried out by a “double-blind” method. This means that neither the patient nor the doctor knows what medicine is being given to the patient. This ensures error-free results.
In addition, we also collect valuable information from studies of different patient groups (e.g. young people, elderly people), different doses, and the use of the medicine in combination with other medicines. The aim is to identify which patients benefit most or have side effects.
What happens if the risk to patient safety is found to be too high?