By Amanda Scanga, Science in Society co-editor
As a master’s student working on a clinical trial, I can say with confidence that participants are crucial to our research. The data they provide is imperative for driving discoveries and getting new treatments on the market. If you have ever wanted to make impactful contributions to science and Canadian healthcare, consider signing up to be part of a clinical trial!
What is clinical research?
Clinical research is a cardinal branch of scientific research that uses data from human volunteers, called participants, to fill medical knowledge gaps and improve patient care. Clinical studies can be observational, meaning that different outcomes are observed in a specific population, or interventional (also called clinical trials), meaning the effect of an intervention on a particular outcome is tested in a controlled way. The intervention can be anything from a new drug or medical device to a lifestyle change. For this article, I will be focusing on clinical trials.
Clinical trials have contributed to our understanding of many diseases and disorders and allowed researchers to test the safety and effectiveness of new drugs and therapies, including the COVID-19 vaccines. Canada is the leading country in clinical trial productivity, conducting four percent of the world’s clinical trials. With a vast network of academic health institutions and research centres, Canada ranks fourth in the world for the number of clinical trial sites. Major global pharmaceutical companies also conduct clinical trials in Canada, contributing to Canada’s reputation as a world-class clinical research environment.
Safety guidelines
Investigators and their team are required to document all forms, medical information, data, and other paperwork for every participant enrolled in a study. This information is kept confidential throughout the study and after its completion. (And yes, there is this much paperwork!) Image: Wesley Tingey on Unsplash.
Participant safety is at the forefront of clinical research. Research teams must meticulously follow the research ethics guidelines provided by Health Canada. Each institution has a research ethics board (REB) that reviews and approves study proposals submitted by investigators. The REB follows the principles of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans to ensure that each study meets the highest ethical standards and that the research participants receive maximum protection. Academic institutions and pharmaceutical and biotechnology companies must follow the same regulatory guidelines and requirements. The study ends immediately if participants experience serious adverse effects or the investigator or staff do not adequately follow safety guidelines or adhere to the protocol. All interventions used in clinical trials are tested in animal models first and must be approved by Health Canada’s Health Products and Food Branch before being tested in people.
Research teams must explain the details of a study to potential participants and outline the potential risks and side effects. Participants can choose to withdraw from a study at any point and for any reason. If the participants suffer any harm or long-term medical issues, the compensation or treatment they will receive is explained to them before the study begins. Participants always receive the care they need.
Recruiting participants
Both healthy people and people with medical conditions participate in clinical research and trials. Recruitment is often difficult and some trials end early due to a lack of participants.
Clinicaltrials.gov is a database that contains all registered clinical trials in various countries. You can search for studies in specific medical fields, using specific treatments, or with specific scientists or clinicians. Each clinical trial will indicate the inclusion and exclusion criteria for the study. Image: public domain.
Scientists employ different strategies to recruit and retain participants. Medical specialists may refer their patients to clinical trials testing a new drug or treatment for a specific illness. Other recruitment strategies include advertising the study through community outreach programs or patient support groups. Healthy subjects are recruited by posting advertisements online or in public areas where they reach a larger population.
Diversity in a study population is crucial. Researchers try to use recruitment strategies that increase diversity as much as possible. However, this can be difficult, especially when dealing with rare diseases or studying a specific population subset. Health Canada prohibits the inappropriate exclusion of potential participants based on gender, sex, race, or ethnicity, but there are no strict diversity quotas. Generally, investigators aim to have an even number of male and female participants and there is a broad range of ages unless the target disease affects a specific age group, for example, children or the elderly.
Benefits and risks of participating in clinical research
Participating in clinical research can provide many benefits. For patients with diseases that do not have many treatments available, being part of a clinical trial can give them early access to a new treatment, and their health may improve if the study is successful. By participating in research, all subjects make valuable contributions to research advancements that can help others receive new treatments and provide information about their illness.
There are potential risks that participants should always consider and discuss with their healthcare provider before taking part in a clinical trial. Perhaps the most important risk to consider is the possibility of experiencing severe side effects (including death) that may be unknown to investigators when the study begins. For patients hoping to improve a medical condition, the intervention may not work or may not be superior to existing treatments, which can be frustrating or discouraging. Finally, participating in a research study may be time consuming and inconvenient if it involves many in-person visits.
What do Canadians have to say?
According to a group of surveyed Canadians, clinical trials are generally regarded positively and perceived as providing personal and societal benefits. Most people felt that clinical trials were somewhat safe, with a small percent of respondents thinking clinical trials are not safe at all. Not surprisingly, the most prominent concerns were the possible side effects of the treatment and its impact on overall health. If you’re interested in learning more about the experience of participating in clinical trials, you can learn about the stories of two real-life Canadian clinical trial participants here.
When I became a member of a research team, I was apprehensive about the idea of having people as research subjects. Now I understand the extensive preparation and effort needed to ensure that participants are treated respectfully, remain comfortable, and are appropriately compensated for their contributions. After all, clinical research would not progress without our participants. In an interview with the Globe and Mail, Dr. Lilian Siu, medical oncologist and professor of medicine at the University of Toronto, said, “emerging science becomes medicine because patients and researchers participate in clinical trials.”
Would you like to learn more about participating in clinical trials? It Starts With Me, a project created to provide information about taking part in clinical trials in Canada, is a great place to start.
Feature image: Commonly used medical supplies that a participant might see during a clinical trial. Photo by Derek Finch on Unsplash.
Very informative and tremendous presentation of the info. I feel the urge to help the scientists of the Great Maple Leaf already!