Ask the Doctor: ‘I’m going through cancer treatment and have been recommended for a clinical trial. Are they properly governed?’

“I am going through cancer treatment at present and have been offered by my hospital consultant to take part in a clinical trial. The consultant recommends that this is something that I do. Are clinical trials safe? I have read horror stories of people taking part in trials in other countries for money with awful consequences! I know this is different as it is in the hospital I am receiving treatment in, but are these trials properly governed?”

Answer from Roisin Conaty, Senior Radiation Therapist and Research Associate and Maggie Coleman, Oncology Research Associate and Oncology Nurse, Beacon Hospital

Firstly, it is important to say that whether you decide to participate in a clinical trial or not, you will receive the highest standard of care available to you for your type of cancer. The ultimate aim of any healthcare professional is to ensure that you receive the best care in the safest environment. Clinical trials are designed to establish this “gold standard” and without them, the high level and quality of cancer treatments available today to patients would not be available. The aim of a clinical trial is to improve the outcomes for people with cancer and to find new and better treatments.

If you decide to take part in the clinical trial offered, a rigorous consent process takes place. Not only is this important, it is a legal requirement as you must be made aware of all of the risks and benefits of taking part in the trial. A designated research team will be assigned to you, which typically includes a research nurse and a research trial coordinator. Their job is to ensure you feel safe and comfortable and to answer any questions that you may have. They will liaise with you throughout the process and are a point of contact should any issue arise in the course of your treatment.

You will also have regular meetings with your doctor who will advise and guide you throughout. A common misconception is that participation in a clinical trial will involve incurring additional expenses or visits to the hospital but clinical trials are designed to negate this and the research team will endeavor to minimise this whilst ensuring you are receiving the best treatment available.

Clinical trials and research have received their share of bad press over the last century or so, but this area is now one of the most highly regulated and controlled areas within medicine. Clinical trials go through rigorous quality checks and procedures before they reach the level of human participation to ensure safety and efficacy. Once a trial involves human participation and/or the use of approved medicines, the regulations governing this are increased.

Each trial is subject to ethical approval from many bodies-IRB, NREC, HRB, FDA, before they can go ahead and once a trial opens in a hospital, the research department is subject to intense scrutiny to ensure that everything is run in an ethical and safe manner. Regular audits and site visits by trial sponsors and governing bodies occur to ensure the trial team are adhering to the strict rules and that above all, the patient is receiving optimum care. Participants who enroll in clinical trials are anonymous and all their information and data is private and confidential under EU law (GDPR), which enforces strict rules around data privacy.

If you are interested in seeking more information regarding the cancer trials that are currently open in Ireland, a good place to start is the Cancer Trials website.

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