Before you take part in a cancer trial, you must give your written consent to do so. This is done by signing a consent form.
You will be given a Patient Information Leaflet, which explains the details of the trial such as the drugs you’ll be given, how long you’ll be on the trial and how many times you’ll need to visit the hospital so that your progress can be monitored. It will also outline the potential risks, so you are fully informed of all aspects of the trial.
Before you sign the consent form you can discuss all details and any concerns you may have with the trial’s Doctor and Research Nurse/Radiation Therapist before you sign the consent form, to make sure all your questions have been answered and you are happy to participate.
Every reasonable precaution will be taken to ensure your safety during the trial.
Participation in studies is covered by an approved insurance policy in the name of the company leading the study. This company could be an international research organisation or a pharmaceutical company. For studies led by Cancer Trials Ireland, this is covered by the State Claims Agency. Your consent to take part in a trial does not alter your legal rights to recover damages should you suffer an injury as a result of participating in a trial.
The study sponsor will comply with applicable guidelines and with Irish law if you become ill or injured as a result of participation in a study. The amount of any compensation paid may, however, be reduced if you have not complied with the instructions issued for this study. In addition, the medical practitioners involved in this study have medical malpractice insurance coverage in public hospitals under the Clinical Indemnity Scheme managed by the State Claims Agency, and in private hospitals by liability insurance covering research.
Key points in relation to consent
- A clinical trial involving a study drug or drug combination has to be approved by the Health Products Regulatory Authority (HPRA). The HPRA is Ireland’s state body responsible for regulating medicines, medical devices and other health products. The HPRA decides if a trial can take place in Ireland. It ensures that the trial will be carried out in line with current Irish, EU and international standards for clinical research.
- A clinical trial must be approved by a national Ethics Committee and/or the Ethics Committee of the hospital in which it is taking place. These independent committees are usually made up of doctors, nurses, medical staff, lawyers and members of the public.
- Specialist cancer doctors from Cancer Trials Ireland also review trials before they are approved.
- Numerous precautions are taken to ensure your well-being during a trial. Patient safety on clinical trials is continuously monitored and subject to legally binding reporting requirements. Pharmacovigilance or drug safety in trials involves monitoring Serious Adverse Events (SAEs) that may be experienced by trial patients.
- All safety information collected during your participation in the trial (whether related or not related to trial treatments/procedures) will be shared with relevant departments in Cancer Trials Ireland (e.g. data management, Pharmacovigilance) and with other participating doctors and researchers, collaborative groups when required. All information collected from your trial participation is de-identified you cannot be identified personally from any documentation.
- You may withdraw from a study at any time if you wish to do so.
Pharmacovigilance
Patient safety on clinical trials is continuously monitored and is subject to legally binding reporting requirements. Patient safety is monitored via the collection of Adverse Events that occur while a patient is on a trial and the sharing of this safety data with CTI and independent doctors at frequent intervals during the study and the reporting of safety data to regulatory authorities, ethics committees and other groups as required.
An ‘Adverse Event’ is defined as ‘Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment’.
All adverse events experienced by a trial patient are recorded in the clinical trial database. All adverse events are collected whether they are considered related or not to the trial treatment/procedure. Some of these events will be considered serious adverse events (SAEs) if they meet certain criteria e.g. require hospitalisation. All SAEs are required to be reported by the trial team at hospital within 24 hours of them becoming aware of the SAE to the sponsor of the trial (such as Cancer Trials Ireland).
Our pharmacovigilance team collect all SAEs in a safety database and process them as per the trial protocol. Each SAE will be reviewed by Pharmacovigilance, and the Chief Investigator (Doctor) for the trial at the time of receipt. These SAEs will also be reviewed at monthly Medical Oversight Meetings by the Cancer Trials Ireland Clinical lead and at Quarterly Safety Monitoring Committee meetings by independent Cancer Doctors. The SAEs can be shared in detailed SAE reports or in simple listing format depending on the seriousness, relatedness, expectedness of the SAE. All SAE data is anonymised so you cannot be identified. The SAEs that are considered at least possibly related and unexpected for the study drug are classified as Suspected Unexpected Serious Adverse Reactions (SUSARs). These SUSARs are reported by Cancer Trials Ireland within defined time limits (7 or 15 days) to national competent authorities (e.g. HPRA), national ethics committees and into the European Medicines Agency database ‘Eudravigilance’ for consideration and review. In addition to the above requirements Pharmacovigilance prepares and submits an annual Development Safety Update Report (DSUR) for each trial to the national competent authorities (e.g. HPRA) and national ethics committees. This DSUR is a summary of all safety data that has occurred to date on the trial, a review of all related SAEs that have occurred over the previous year and any other relevant safety information regarding the trial treatments.
Pharmacovigilance is conducted in adherence to national and EU regulations and is subject to review and inspection by the HPRA. Pharmacovigilance staff ensure the most up to date regulations are adhered to by attending training sessions/webinars on updated regulations, being involved in Pharmacovigilance working groups, receiving alerts from the HRPA and other organisations regarding changes to regulations, updates to website. Cancer Trials Ireland’s pharmacovigilance staff ensure compliance with these regulations by following Standard Operating Procedures.
If you require further information, please contact the pharmacovigilance department at pharmacovigilance@cancertrials.ie.