CLINICAL TRIALSProviding our patients with the latest medical advancements through Clinical Trials. EMAIL US
What are clinical trials?
Clinical Trials are designed to evaluate the safety and effectiveness of new drugs, devices, or behavioural therapies in medicine. Clinical Trials are also referred to as Clinical Studies, Clinical Research Trials, Research Trials, or Research Studies.
They help find new ways to prevent, detect, or treat diseases that are safe and effective.
- Your participation in any clinical trial is voluntary. You may stop participating at any time.
- All personal information collected during a clinical trial is keep confidential at all times. You are given a special code and that is how your information is recorded.
- Before you participate in any study you will be given all information about the research study, its risks, its benefits and all your questions will be answered by Dr. Brown-Maher and her study team.
- You will be given the research study information and a consent form to take home and read over. You can then decide if you wish to participate in the research study.
- Each clinical trial includes a consent form that will be reviewed and signed by the participant and Dr. Brown-Maher. The consent form is an important document that outlines all the information about the clinical trial including all procedures, potential risks and benefits, information about protecting your privacy, all procedures or treatments to consider, and exactly who to contact with questions.
Why do we need Clinical Trials?
- Does the new treatment work in people? If it does, doctors will also look at how well it works. Is it better than treatment now being used? If it’s not better, is it as good and cause fewer side effects? Or does it work in some people who aren’t helped by current treatments that are available?
- Is the new treatment safe? No treatment or procedure (even one already in common use) is without risk. But do the benefits of the new treatment outweigh the risks?
- Is this treatment better than the standard treatment given for this disease currently? Clinical trials help show if a new drug or treatment, or a new treatment combination, works better than what is now being used.
Different Phases of Clinical Trials
Clinical trials are usually conducted in phases that build on one another. Each phase is designed to answer certain questions. Knowing the phase of the clinical trial is important because it can give you some idea about how much is known about the treatment being studied. There are multiple benefits and risks to taking part in each phase of a clinical trial.
Phase 1 Trials
Phase 1 studies of a new drug are usually the first that involve people. Phase 1 studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects. Although the treatment has been tested in lab and animal studies, the side effects in people can’t be known for sure. These studies also help to decide on the best way to give the new treatment.
Phase 1 trials carry the most potential risk. But phase 1 studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose to join phase 1 trials when all other treatment options have already been tried.
Phase 2 Trials
If a new treatment is found to be safe in phase 1 clinical trials, a phase 2 clinical trial is done to see if it works in certain types of a disease. In some studies, the benefit may be an improved quality of life. Many clinical trials look to see if people getting the new treatment have a better quality of life, better clearance of their skin, etc, than most people have without the treatment.
Larger numbers of patients get the treatment in phase 2 trials, so less common side effects may be seen. If enough patients benefit from the treatment, and the side effects aren’t too bad, phase 3 clinical trials then follow.
Phase 3 Trials
Treatments that have been shown to work in phase 2 clinical trials must succeed in one more phase before they’re approved for general use. Phase 3 clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.
Because we do not yet know which treatment is better, study participants are often picked at random (called randomized) to get either the placebo treatment or the new study treatment. When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study.
As with other trials, patients in phase 3 clinical trials are watched closely for side effects, and treatment is stopped if the risks are too much.
Phase 4 Trials / Post Marketing Observational Studies (PMOS)
Drugs approved by Health Canada are often watched over a long period of time in phase 4 studies. Even after testing a new medicine on thousands of people, all the effects of the treatment may not be known. Some questions may still need to be answered. Are there rare side effects that haven’t been seen yet, or side effects that only show up after a person has taken the drug for a long time? These types of questions may take many more years to answer, and are often addressed in phase 4 clinical trials.
You can get the drugs used in a phase 4 trial without being in a study, as they are already Health Canada approved and available by prescription. And the care you would get in a phase 4 study is very much like the care you could expect if you were to get the treatment outside of a trial. But in phase 4 studies you’re helping researchers learn more about the treatment and doing a service to future patients.
Areas of Interest
PURE: A Registry of Patients with Moderate to Severe Chronic Plaque Psoriasis in Canada and Latin America (CLOSED for Recruitment)
PSOREAL: Managing Psoriasis in the Real World. One year prospective, observational study of the journey of patients with plaque psoriasis prescribed calcipotriol betamethasone aerosol foam or other topical therapy (CLOSED for Recruitment)
PSoHO: Psoriasis Study of Health Outcomes. An Interventional Observational Study of 3-Year Health Outcomes in the Biologic Treatment of Moderate-to-Severe Plaque Psoriasis
Corrona-PSO-500: Corrona Psoriasis Registry
BHS-CAN-DERM-002: A Canadian Phase IV, Multicenter, Single-Arm Study to Evaluate the Effectiveness of Treatment with Brodalumab (SILIQ) in Psoriasis Patients with Inadequate Response to their Current Biologic Agent Regimen (CLOSED for Recruitment)
VALUE: Multi-Country Prospective Observational, Cohort Study of Patients with Moderate to Severe Chronic Plaque Psoriasis (CLOSED for Recruitment)
REGIMEN: Treatment Optimization of Commonly Used Biologics for the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis (CLOSED for Recruitment)
CIMREAL: A multicenter, non-interventional, prospective study to assess the effectiveness of Certolizumab Pegol in patients with moderate to severe plaque psoriasis in daily practice (CLOSED for Recruitment)
DUOFIRST: A Phase IV, Canadian Multicenter Study, to Evaluate the Safety and Effectiveness of Duobrii (halobetasol propionate 0.01%/tazarotene 0.045%) in Patients with Moderate-to-Severe Plaque Psoriasis (CLOSED for Recruitment)
BHC-CANDerm-003(CARE): A Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity
CAN TARGET PSORIASIS: Canadian Treat-to-Target Practice Survey of Real-World Interventions and Strategies in Psoriasis
CC-10004 PSOR-025: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital Psoriasis (CLOSED for Recruitment)
CIMCARE: Multicenter,randomized, parallel-group, double-blind, placebo-controlled (12-17 years) including a single open label arm (6-11 years) study to evaluate the efficacy,safety, and pharmacokinetics of certolizumab pegol (CZP) in pediatric study participants with moderate to severe chronic plaque psoriasis (PSO)
DERMAVANT: A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Atopic Dermatitis (AD)
DEV-AD: A 4-Week Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Safety and Efficacy Study of the Three Concentrations of PUR 0110 Cream Applied Twice Daily in Mild-to-Moderate Atopic Dermatitis (CLOSED for Recruitment)
Chronic Hand Eczema (CHE)
Hidradenitis Suppurativa (HS)
Dr. Brown-Maher and Study Team
Dr. Brown-Maher and her team are always seeking out what’s new and upcoming in dermatology medicine and treatments. Providing her patients with the latest medical advancements, through clinical trials, Dr. Brown-Maher understands the importance of her patients living with their skin disease and being able to provide them with new treatment options is very important to her.
Patient care and safety is our number one priority at Skincare Studio Dermatology Centre. You can relax and have trust in us, with all of our clinical trials being fully approved by our local ethics board, right here in Newfoundland.
Participants for all clinical trials are recruited from Dr. Brown-Maher’s private Dermatology Clinic. If you are interested in learning more, please contact our Clinical Trials Coordinator, David at 709-771-6954.
Want more information about how clinical trials are conducted in Newfoundland? To find more information about ethics reviews in our province, please visit the Health Research Ethics Authority (HREA) website.