It is important to learn how well new treatments work and also to compare them with established techniques and medications to learn where there are advantages and disadvantages to a new therapy. It is equally important to establish whether the apparent benefits are due to the specific effects of the therapy or to the powerful placebo effects which can occur in all conditions and with all treatments.
All new treatments used in Canada and the U.S. must go through a rigorous clinical trial process to ensure their safety and effectiveness before they are approved.
Proper scientific method is very important when conducting clinical trials. Every step is documented and international quality and safety regulations must be followed. In fact, all parts of the study must be approved by an independent ethics review board.
One of the advantages to participating in clinical trials is the extra attention patients receive from doctors
By the time a new medication is tested on volunteer patients, the drug has already undergone several pre-clinical phases of research. The chemical make-up of the drug has been tested in a lab for toxicity and general safety. Next, the effects of the medication are studied on laboratory animals to further ensure its safety and to figure out how the drug actually works.
New therapies are tested on people only after promising results are shown in pre-clinical phases and if there are no warning signs of serious harmful effects. In early clinical studies, the new medication is often tested on healthy volunteers and potential side effects are recorded.
All of this occurs before ill patients test the medication. Of course, when a patient is involved in a clinical trial, there are potential risks and all risks are discussed with the volunteer before the trial begins. If at any point during the study the patient is concerned, they are free to stop participating.
However, along with potential risks, many benefits come with medical research – for both the patient and the medical community. By participating in a clinical trial, the patient has the opportunity to take part in helping doctors understand disorders and new treatments.
Not only will the participant be assisting in advancing medical knowledge, but during drug studies there is also a chance the patient will receive a new treatment for his or her condition that may be very effective.
Perhaps one of the best advantages to participating in a clinical trial is the extra attention and time that is taken with patients. For every trial there is a dedicated team of medical professionals who work with the participants and there are usually more visits to the doctor than in a regular medical setting. Also, while participating in the trial, all medication and treatment costs are covered by the study at no cost to the patient.
Doctors conducting clinical research get exposure to new therapies and learn in detail how the treatments work and whether they are effective. This experience gives them a broader knowledge base from which to treat patients in their regular practice.
Clinical studies are crucial for all areas of medicine as we still have much to learn about how to treat medical conditions of all kinds.
Dr. Latimer is president of Okanagan Clinical Trials and Kelowna psychiatrist.