Thinking of participating in a clinical trial? Clinical trials bring treatment advancements forward to the broad patient community and are essential to the drug development process. There is a lot to consider and weigh for people thinking about participating in a clinical trial, such as the time commitment and evaluating the risks and benefits before deciding whether to be part of one. ESC recently asked Toronto-based dermatologist and researcher Dr. Sameh Hanna to offer his valuable insights on the clinical trial process and what patients can expect if they decide to embark on this journey.
ESC: What are clinical trials?
Dr. Hanna: Before new medications receive Health Canada approval, they undergo a rigorous assessment process for efficacy and safety in clinical trials. The clinical trial process typically has three or more phases, gradually progressing from assessing safety with a smaller group in Phase 1 to confirming efficacy and safety with larger participant numbers in Phases 2 and 3. Evaluations of treatments often continue past phase three and after the drug is available to patients. The term “randomization” describes how some patients will get access to the actual drug, and some will get access to a placebo. This process helps to determine treatment effectiveness, and data can be compared across the two groups.
ESC: Why are clinical trials essential for advancing atopic dermatitis treatment?
Dr. Hanna: Clinical trials form the foundation of medical advances. Every major AD treatment breakthrough has happened because of clinical trials. Without clinical trials, no new medications for AD would be available. The last decade has witnessed remarkable strides in AD therapies, signalling a promising new era for AD management.
ESC: What does being part of a clinical trial involve?
Dr. Hanna: Participant involvement varies based on the drug tested (e.g., a cream, an oral medicine, or an injectable) and the trial phase. In some trials, participants may visit the trial site every month at first but less frequently as the study continues. The frequency and length of visits may differ for each trial. Some visits can take two or three hours, and trials can take months. Time commitment, clinic visit frequency, and appointment duration differ, with initial visits often lasting longer than follow-up appointments.
There is also governance around how clinical trials operate. ICH-GCP (or International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice) safeguards participants, ensuring ethical conduct, scientific quality of clinical trials, and participant safety.
ESC: Are participants compensated?
Dr. Hanna: Participants are often financially compensated for their time and effort in trial visits, and compensation varies. The payment is intended to cover the participant’s expenses and not be a major incentive to participate in the trial, as this might be considered unethical.
ESC: Can I stay on the drug once the trial is over?
Dr. Hanna: Sometimes, the drug may be approved by Health Canada before the trial finishes, allowing participants to continue the medication. However, a trial can end before Health Canada approves the drug, and even if the participant has done well on the drug, they will have to come off the treatment.
ESC: What else should participants know about clinical trials?
Dr. Hanna: You can end your participation in a clinical trial anytime. However, it is important to fully understand the potential risks and benefits before agreeing to join it.
Potential upsides can include:
- Access to new or more effective medications that are not yet commercially available or that may not be available for insurance or financial reasons
- Closely monitored health by the study team
- Contributing to scientific advances that can help others with the same condition
Potential downsides can include:
- Possible randomization to a placebo group
- Being required to attend study visits at specific times, keeping diaries, and answering questionnaires throughout the study
- Possible side effects of newer medications that are not yet known
To learn more about the drug development process, visit https://eczemahelp.ca/research/drug-development-process/
To learn more about clinical trials near you, visit eczemahelp.ca/research/#clinical-research-trials
Eczema Society of Canada thanks dermatologist Dr. Sameh Hanna, MD, for his volunteer contribution to this educational content.
Disclaimer: Information provided in this resource does not constitute medical advice and is not intended to be used as a diagnostic tool. The information is up-to-date at time of publication. All medications, interventions, and treatment plans have risks and benefits, and it is important that individuals discuss their or their child’s specific health care needs with a qualified health care professional.
December 2023
