Clinical research includes two types of research, observational studies and clinical trials. Both types of research aim to determine the safety and how well a product performs (for a certain intended purpose). Clinical research can assess the safety and effectiveness of medications, natural health products, foods, and devices intended for human use. The difference between observational studies and clinical trials is that an observational study does not involve providing a study product and a clinical trial does. Volunteer participants are a necessary component of research as participants help facilitate new discoveries (e.g., learning something new about an existing marketed product, or finding the safest dose for a new product, and answering many more important research questions).
We only recruit for studies once they have been approved by an independent Research Ethics Board (REB), and if applicable, permission from Health Canada is granted. After a study is granted ethics approval, we begin the recruitment process by contacting potential candidates by phone, email and social media. Sometimes we also advertise at community events, in print, online and through radio or television advertisements.
Once potential volunteers let us know they’re interested in participating, we direct them to our website where they answer short questions about their medical history, health status and lifestyle. Next, we invite eligible participants to our research center for a pre-screening or screening visit to find out if they fit all of the criteria of the study. Subjects that meet the study criteria are then invited to enroll in the study.
Depending on the study, participant involvement can range from filling out a simple questionnaire or providing a one-time finger-prick blood sample to completing multiple site visits or full-day visits for repeated sampling. Before enrolling in a study, each participant has the opportunity to review a Research Ethics Board (REB) approved Informed Consent Form (ICF).
Before you participate in a clinical trial, you will be given complete information about the study. After receiving the information about the study details, you will be asked if you voluntarily want to take part in the study. This is known as “Informed Consent”. Informed Consent is ongoing. At each visit, you will be asked if you continue to give your consent to take part in the study. If a new consent form is approved, it will be reviewed with you and you will be asked again if you wish to continue taking part in the study.
The clinical trial process varies for all studies. No two studies are exactly alike. Most often, you will attend a screening visit where you will be assessed against study criteria (“Eligibility Criteria”). At this first visit the first thing you will do is review an Informed Consent Form so that you can decide (after being fully informed of the study-specific details) if you want to voluntarily consent to taking part in the study. After that, you can expect to discuss your age, gender, race/ethnicity, health history (including current/past conditions, surgeries and procedures), current medication use (drugs and supplements), and lifestyle and dietary habits. Most often, you will also likely have your height, weight, and seated blood pressure and heart rate measured. If you appear to meet the initial eligibility criteria, you may or may not have blood taken. You will be compensated for your time and efforts (even if you do not meet the study criteria). After your initial visit you may complete a daily diary or some type of home-based sample collection, or just return after some time for your second visit. The second visit is often called the “baseline visit” where we continue to assess your eligibility for the study and check if you followed any study restrictions since your last visit. Similar procedures (e.g., weight, blood pressure, heart rate) may be done and other assessments or questionnaires depending on the study. If you are determined to be eligible at this visit, you will be enrolled and may receive the study product (which could be an active product or a placebo/inactive product) for the first time. Each study varies in the number of visits you need to attend, the duration of those visits, and the type of procedures performed at each visit.
The benefits of participating in a clinical trial vary from a potential direct benefit to no direct benefit to you at all. However, while participating in a clinical trial may not directly benefit you, it may help benefit others in the future. In addition, you may have a chance to try a new product that is not yet available on the market. While participating you will have direct access to healthcare professionals who will be there to assist you and answer any questions you may have. By participating you will have the satisfaction that you are contributing to the advancement of medical knowledge and helping identify possible new therapies and treatments.
The length of study may vary from a single day to studies that may last months or years. This information is provided in our advertisements for specific trials. You will also be informed of the duration of the study when you are screened for a potential study and in the informed consent.
Each clinical trial will be different. Be sure to understand what is being asked of you when you voluntarily agree to participate in a clinical trial. Besides keeping appointments and taking investigational product, you may have to fill out multiple forms or keep a diary. Some studies require you to answer follow-up questions, after treatment is over. Again, this will vary greatly between studies.
There is no cost to you for participating in a clinical trial, other than transportation between your home and our clinic. All study materials including investigational product will be provided by Apex Trials on behalf of the clinical trial Sponsor at no expense to you. At Apex Trials we offer free parking to our trial participants.
Clinical trials may be sponsored or funded by a variety of sources, including:
- Federal agencies such as the Canadian Institutes of Health Research (CIHR)
- Foundations such as the National Cancer Institute of Canada
- Hospitals, research institutes and universities
- Natural Health Product and Pharmaceutical companies
Participants of clinical trials are volunteers. This means that you can withdraw at any time, for any reason, without penalty or consequence.
Some trials request that to “washout” of a medication prior to starting the clinical study. This is a period of time where you may be asked to stop taking certain products (e.g., food, drugs or NHPs) in order to be eligible to participate in the study. Only a qualified medical professional (e.g., licensed M.D.) is authorized to determine if you are able to stop a health product, and will only request you to do so if it is not believed that it will put your health at risk. You always have the right to not participate in the clinical study.
In some studies you may receive more than one investigational product in an order (sequence). In these studies, you may be required to have a “washout” period between the study periods. The washout period, in this case, is a period of time during which you will not be receiving the investigational product.
Details of any washout periods will be provided during the screening process.
Yes. At Apex Trials, we ensure that there is medical oversight by a qualified healthcare professional for our natural health product and pharmaceutical clinical trials.
As a participant, do I continue to see my own family doctor while participating in a clinical trial?
Yes. During a clinical trial you will have access to the study investigator (who is a qualified health care professional); however you should continue to see your family doctor as you normally would. The study investigator is there to oversee your safety while volunteering as a participant and will ensure you are a right fit for the study, the study is safe for you to take part in, and will monitor your participation for any changes in your health along the way. More information on safety oversight can be found during your review of the study-specific Informed Consent Form (ICF).
A placebo is a product containing ingredients that do not provide any health effects. The placebo is usually made to look like the active product. A placebo is used to determine how the participants would normally respond in order to compare if the active treatment works or not. Some studies may use another active product as a comparator instead of a placebo to determine if the investigational product is as good as or better than a current therapy (these types of studies are known as bioequivalence studies and comparator studies, respectively).
Some clinical trials are blinded or double-blinded, meaning you, or you and the research team, may not know which study product you received while in the study. This is to prevent bias (either you or the study staff altering data or reporting false data based on knowing the product assignment). After your participation in a blinded study is complete you can ask staff about what study product you were taking. It will be the Sponsor’s decision on whether or not we can inform you of which study product you were taking (never hurts to ask!).
You will be asked to provide photo identification that contains your name and date of birth. We accept government-issued photo ID, such as your passport, nexus, citizenship card, driver’s license and age of majority card.
You may only participate in one intervention study at a single time. The reason for this is to ensure that results obtained are due to the intervention you are receiving as well as to prevent any unforeseen interactions between investigational products. For most studies there is usually a 30 day waiting period between participating in intervention studies, whether at Apex Trials or at another research company. This waiting period is a safety measure to ensure that the investigational product is no longer in your body and is also based on the amount of blood that you have given.
The types of samples collected during a study may vary and could include:
- Other biological sample types
During the initial screening process you will receive specific details on the types, quantity, frequency and purpose of samples to be collected during the study. Not all studies require samples to be collected.
Privacy and confidentiality is an important part of clinical research. At Apex Trials, we ensure that only those people that are authorized have access to your personal and identifiable information. Apex Trials complies with Personal Information Protection and Electronic Documents Act (PIPEDA) the Personal Health Information Protection Act (PHIPA) to protect your personal information. Learn more about participant confidentiality
Pregnancy testing may be required for women of childbearing potential for some studies where an investigational product will be tested (unless the study is specifically targeting this population). Females who are pregnant, lactating, or unwilling to use approved methods of birth control may not able to participate. Individuals with the potential to impregnate others may need to agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy may also not be acceptable.
We require 24 hours notice to reschedule appointments. If you are currently taking part in a trial, the amount of days allowed to reschedule your visit are pre-determined during the development of the study.
My study requires me to stay for several hours in the clinic. Are meals provided? What will I do while staying at the clinic?
During long stays in the clinic meals and snacks may be provided. The study Informed Consent Form will provide more details on visit meals and/or snacks.
You may bring your own laptop or mobile device but we ask that you bring your own headphones so that you do not disturb other participants.
There are several reasons why you may not have been eligible for a certain study as each study has specific requirements called inclusion and exclusion criteria. You may discuss your eligibility assessment with the study investigator.
Our core clinic hours are 8:30am to 4:30pm Monday to Friday. Depending on the requirements of the study, arrangements may be made for visits outside of the core clinic hours, including weekends.
Our facility is located in Guelph, ON at 120 Research Lane in Suite 203 (on the 2nd floor). The closest major intersection to our facility is Stone Rd and Gordon St.
You can always view upcoming studies on our website by clicking the "For Participants" tab in the main navigation bar of our website. Through our website you can also join our mailing list to find out about upcoming studies. You always have the option to be removed from our mailing list at any time.
Participants are not permitted to bring their pet to the clinic for safety reasons. Generally, you should not bring your child to the clinic. Please contact us if you have a question or concern.