What’s It About
Before any treatment can be provided to the general population, it must go through rigorous testing to ensure it is safe and effective. This process of experimentation is referred to as a clinical trial.
These trials occur in phases, where the drug is tested on patients or on healthy volunteers. Clinical Trials are guided by strict codes of ethics which protect the participants and authorisation must be received from the Health Products Regulatory Authority before any trial can be carried out in Ireland. There are also strict government regulations governing when drugs are safe and effective enough to be offered as a treatment, working on clinical trials means working towards passing the drug through these requirements. Most drugs will fail at some point in the clinical trial process.
How the trials will be conducted varies depending on the nature of the medical product under development. Generally, a phase 1 trial will involve a group of healthy volunteers, with the focus being the safety of the candidate drug. These volunteers will be closely monitored as small doses are delivered. Any potential medicines found safe enough will progress to the next phase of trials, where the compound will be tested on patients who have the condition that the medicine is believed to be a treatment for, as well as continued observation of the safety of the medicine. The focus of this stage of trials is the effectiveness of the medicine, once again the patients will be monitored extremely closely.
Following this the successful medicine will move onto trials where it is tested on a much broader range of patients, to ensure it is suitable for general use. Trialling on more people produces more rigorous information on the safety and effectiveness of the medicine.
Clinical Trials in Ireland
The number and size of Clinical Trials conducted in Ireland has increased over the last decade, particularly in recent years. While the number employed in clinical trials is still relatively small, with a few hundred clinical investigators, the work is rewarding, offering a means to assist patients by offering innovative approaches while contributing to the development of life saving products. There is room for growth in the number of clinical trials conducted in Ireland with many similarly sized European countries conducting many more clinical trials each year.
Nature of the Work
At the entry level your work will involve setting up clinical trial sites, note taking, organising the trial and managing documents. As you move into more senior roles you will take on more responsibility, including assigning staff, overseeing ethical and regulatory issues and making decisions about problems faced in the trial process.Clinical trials require an inquisitive mind, an aptitude for thinking logically, an eye for detail and excellent numeracy. As regulatory and ethical matters are so important it is vital that all staff can work effectively within these requirements. This will require organisation, excellent communication and detailed note-taking.