An Introduction to Clinical Research Trials
Clinical research and trials are at the core of medical advances.
The goal of clinical research trials is to ensure any new treatments, medication or tests are safe.
What is Clinical Research?
Clinical research trials examine new approaches in detecting, preventing and treating diseases. Treatments can include new drugs or drug combinations, surgical devices or procedures, or new courses of existing treatments.
Participants in clinical trials do so to aid others and further the advancement of science or to receive the newest treatment, additional attention and care for their illness.
Once the new procedure or therapy is tested in animal studies, the most promising drugs are then tested in clinical trials, which are organised in phases. There are Phase I trials all the way up to Phase IV trials. Phase I is conducted with a small group of volunteers, while Phase III has the largest group and Phase IV tracks the drug after it has been made available to the general public.
There is a protocol that defines the plan of the clinical research. It is carefully designed to safeguard the volunteer’s health. A doctor known as the principal investigator (PI) leads the clinical study, with team members regularly monitoring the participants.
How the Trial Works
Randomisation decides which treatment is administered to which volunteer, rather than choice. This avoids bias within the trial, and the results are compared at certain points during the trial. Some trials last for years, and some end unsuccessfully.
Factors such as trial length, discomfort and side effects or risk depend on each trial. Some studies require a large commitment in effort and time from the volunteer. Just as routine medication involves some risk, there are possible benefits and risks in clinical research trials. Ask questions and raise issues that you are concerned with any time during the trial.