Driving innovation while ensuring safety
Clinical trials are essential for evaluating the efficacy and safety of our medicines. During the development of a medicine, clinical trials allow us to identify its most common side effects, appropriate dosage and, most importantly, whether it positively benefits the health of the patient.
Clinical trials can also be conducted for existing medicines, to further evaluate their long-term use or to assess new uses (called indications) for those medicines.
Regulatory authorities, such as the European Medicines Agency (EMA) or the Irish Medicines Board (IMB), review clinical trial data to determine if a particular medicine may be licensed. In some cases, they will balance the benefits of a medicine against the risk of side effects. This process, which is known as a benefit/risk assessment, varies depending on the severity of the condition being treated.
The success of our clinical trials is fundamental to the success of our business. It is essential that we carefully manage all related issues and risks. We must ensure that:
- The safety, well-being, legal rights and ethical concerns of those taking part are ensured
- Products are made available in all countries where participants live once they have been approved
- Medicines are not tested in vulnerable people unless they are expected to benefit from the treatment
- Patients have the opportunity to join as well as to opt out of trials appropriate for their condition
- We publish all scientifically- and clinically-relevant information from trials promptly to give healthcare professionals a balanced and scientific overview of the performance of our products.
Our global clinical trials registry helps patients find Roche-sponsored trials that may be appropriate for them, and an online database shares the results.
Conducting clinical trials in Ireland
Before we conduct any clinical trials in Ireland, we apply to the Irish Medicines Board (IMB) for authorisation. The IMB use existing medical and scientific data on the medicine when they make their decision. This data is reviewed by the IMB to determine whether the medicine is scientifically valid and properly researched at the pre-clinical trial stage. We must also obtain a positive opinion from Ethics Committees, which are independent of the pharmaceutical industry and established and supervised by the Department of Health and Children. These Ethics committees can reject a clinical trial on ethical grounds.
Once authorisation has been received from the IMB and the Ethics Committee(s), the clinical trial can start.
All clinical trials have to be conducted in accordance with Good Clinical Practice (GCP) and the Irish Medicines Board authorisation. Clinical trials are regularly audited by the IMB to ensure compliance.
In Ireland, we often work with clinical research groups, such as the All Ireland Cooperative Oncology Research Group (ICORG) to manage and facilitate our clinical trials. We also provide support for independent clinical trials conducted in Irish academic institutions and hospitals.