Safety in Clinical Trials

All medicines are subject to rigorous testing before they are approved by regulatory authorities (such as the US Food and Drug Administration). Before a medicine is prescribed to patients, findings from early laboratory studies are carefully analysed by Roche scientists and discussed with regulatory authorities. The medicine then undergoes a long process of investigation using well-designed and controlled clinical trials. Controlled trials are those which compare the new medicine to a placebo or existing medicines. They are usually “double blind” so that neither the patient nor the doctor knows which medicine the patient is receiving. This ensures the results are not biased. These studies or trials gather information about the efficacy and safety (e.g. side effects) of new medicines compared to existing treatments. In addition, information is gathered by studying different patient groups (e.g. young, elderly), different dosages and the use of a drug in combination with other medicines to see which patients benefit the most or have side effects.

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. For further information, see responsible R&D.

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.