Clinical trials (sometimes called a clinical study) are essential to test potential treatments for safety and effectiveness before approval for use in the wider population. Clinical trials are a final step in a long process of drug development, this normally involves extensive pre-clinical research often including animal testing to identify any dangerous side effects before treatment in people. Only treatments that are evaluated as reasonably safe and show the most promise, progress to clinical trials.
Regulatory agencies require clinical trials, such as the European Medicines Agency (EMA) before a new product can be brought to the market. The EMA are committed to protecting participants in clinical trials and providing reliable information to the public.
Clinical trials are separated into four Phases:
- Phase 1 is when the drug is tested on a group of healthy volunteers.
- Phase 2 involves the drug being tested on a group of patients with the disease to determine its effectiveness.
- Phase 3 Is when the drug is tested on a larger group of patients with the disease and compared with current treatments (or in some cases a placebo)
- Phase 4 involves gathering data from a large group of patients on treatment after the drug is approved.
Participating in a clinical trial
Participating in a clinical trial is voluntary and there may be factors that need to be weighed before making a decision that is right for you. These issues may include the time involved for visits to the hospital, travel requirements to clinic appointments, and others, may need to be considered.
To volunteer for a clinical trial, you must meet the eligibility criteria. Eligibility criteria are the rules for who can be recruited for a clinical trial, and include inclusion and exclusion criteria which are specific for each trial. These may include: age, stage of disease, previous treatment history, and presence of other medical conditions. The eligibility criteria aim to give the trial the best possible chance of success and help protect study subjects.
Before enrolling on a clinical trial each candidate will undertake a screening process. There is no guarantee that a candidate will be enrolled until the screening data has been evaluated. Similarly, there is no guarantee that an individual in a clinical trial will actually receive the treatment. In the current protocol, participants will receive either the treatment, or the conventional treatment.
Prior to enrolling the trial coordinator will discuss elements of the trial such as: the length of the study, the number and interval of visits required, the lab work and other tests required during the study and the scope of the questionnaires that are completed at each visit. The trial coordinator will describe any study related physical exam or outcome measures. The study consent will be described, shared and later discussed prior to enrolment.
It is important to note that your participation is voluntary and that you may, at any time, resign from the study without penalty. The cost of all the tests and examinations associated with clinical studies are covered and there are no trial-related costs.