Clinical research is the name given to any research that is undertaken using human participants. Research involves trials of new treatments, which could involve devices, pharmaceuticals or other therapies including new surgical techniques.
What is Clinical Trial Research?
Clinical research involving pharmaceutical products or devices is classified by 'phases'.
These are generally defined as:
First time into humans
These studies are performed in healthy volunteers and require extensive in-house monitoring and observation following treatment. The trials are designed to establish the safety and tolerability of the treatment, and to establish the approximate dosing range. Phase 1 trials typically involve 20-60 people and are conducted within a hospital or specialist Phase 1 Unit environment.
P3 Research does not undertake this type of trial.
Studies in patients
These trials are designed to show that the treatment works in the ‘target’ population i.e. people with the disease that the treatment is designed for. Phase 2 studies typically involve 50-200 patients and may involve many tests to look at what effects the treatment has on the body and how the treatment is absorbed, metabolised and eliminated from the body. Usually, a range of doses are tried to look at differences in effect, and any side-effects that are seen. These studies will help the researchers find the best dose and dosing interval that has the desired effect.
P3 Research are specialists in this type of Trial.
Refining of dosing and side-effect profiles
These trials usually involve very large numbers of patients (several hundreds or thousands), and are commonly performed across the globe in multiple countries. The prime objective is to compare the new treatment with current treatments and to identify any side-effects that weren’t seen in the Phase 2 studies. These studies are generally performed on an outpatient basis in Hospitals, General Practices and specialist facilities. They may run over many months or even years.
P3 Research participates in many large International Phase 3 clinical trials.
These trials are generally conducted after the product has reached the market. They may involve several hundred or thousands of patients and are designed to see how the product is received by the general public. These studies may identify rare side-effects that were not seen in the pre-marketing Phase 1,2, and 3 trials. These studies may be performed by GPs or other health-care providers in a range of facilities.
P3 Research is not often involved in Phase 4 studies.
The staff at P3 are very friendly and helpful and made the experience easy to cope with. I wouldn’t hesitate to volunteer for any similar trial at P3.
I was invited to take part in a study of a new medication for pancreatitis. The study was for 3 nights and the staff made me feel very comfortable and put my mind at ease. I would put my hand up to volunteer again.
I have secondary progressive MS and participated in a year long drug trial at P3. It was a great experience. I was really well informed, so cared for during the weekly infusions and assessments and I would join another trial with P3 like a shot. Thank you especially Mary and Dean.