What’s It About
Before any new drug or treatment is licensed for use it must go through a period of rigorous testing to ensure the efficacy and safety of the product. Developing a drug or treatment is a complex process. It takes many years of research and huge financial investment before a new product is licensed for use.
Clinical trials play a vital role. Clinical Trials are designed to see if there is a more effective and safe way to treat a certain disease. There is no standard length of time until a product is approved. Typically, different phases of clinical trials will take many years to complete.
Clinical Trials in Ireland
In Ireland, all drugs must successfully complete numerous rounds of clinical trials before they are granted a licence to be openly prescribed. Clinical trials are crucial to allow new effective medicines to reach distributors, hospitals, doctors, healthcare professionals, and patients.
The Health Products Regulatory Authority regulates new drugs and medicines in Ireland before being used by the public. A recognised Research Ethics Committee (REC) will also review the trial prior to enrolling any patients.
Human participants take part in clinical trials to evaluate the risks, limitations and benefits of new drugs or medicines before they are approved. A follow up study is carried out to confirm the long-term clinical performance and identify any adverse effects.
There are different types of clinical trials - controlled, double-blind, randomised and placebo. Controlled trials need two different groups of patients, one will get the new treatment and the control group will get the standard treatment. In double-blind trials patients do not know whether they are receiving the new or standard treatment. Randomised trials involve patients being randomly selected as to whether they receive the new or standard treatment. Placebos, which look like real drugs but have no effect on patients, are sometimes used when there is no standard treatment available to compare the new treatment to.
Clinical trials generally run over four phases, but this may vary. Phase One is the first time the new drug is used on a small number of patients after being tested in a laboratory. Phase Two involves a larger number of patients, possibly up to one hundred. Phase 3 involves thousands of patients from different hospitals and countries. If the Phase 3 trial shows that the new drug is working, it is licensed for use. Phase 4 of the trial will monitor its effectiveness and any side effects. At all stages of the trial patients are monitored extremely closely by their consultant and research team of healthcare professionals.
Nature of the Work
Working in clinical trials you will be at the cutting-edge of medical research. You may have the choice of a wide variety of work environments such as a university, laboratory, government research institute or pharmaceutical company. Working in this fast-paced life sciences sector you will be part of a multidisciplinary team of scientists, medical and healthcare staff, data analysts, patients, and pharmaceutical company representatives.
You may start as a Clinical Trial Assistant, Associate or Coordinator and with extra responsibility, progress to Clinical Trial Supervisor and Clinical Trial Project Manager. In all positions excellent interpersonal skills are required to liaise with patients, colleagues, regulatory bodies, and industry partners. You should be detail oriented, numerate, and capable of solving problems as they may arise in the trial, using your observations and evidence to make critical judgements. Skills in data analytics, record keeping, IT and project management are highly desirable. You should be capable of working in a highly regulated environment where ethics and patient confidentiality are central to the role.
Despite Ireland being a global leader in Biopharmaceuticals, and an increase in clinical trials in recent years, there is scope for growth. The Irish Pharmaceutical Healthcare Association research has noted that similar sized countries conduct many more clinical trials annually. Alongside major pharmaceutical companies such as Janssen, who are supporting the first clinical trial in CAR-T treatment of the blood cancer multiple myeloma, they are working towards increasing the number of clinical trials taking place in Ireland.
The work is challenging and rewarding. Unfortunately, some patients on the trial, by the nature of their serious illness may not survive, whilst for others the new drug may literally give them a second chance at life. You will have the satisfaction of knowing that, when a new drug is successfully brought to market, you have contributed to medical research and transformed patients’ lives. While most positions require a third level qualification in science or related disciplines there are opportunities to complete a Laboratory Apprenticeship which is open to school leavers or those who wish to upskill or retrain. The National Institute for Bioprocessing Research & Training also offers many courses at Certificate and master’s Level, or short term courses for those working in the industry who wish to upskill.