Clinical research refers to studies in which people participate as patients or volunteers for scientific research purposes. Clinical research is often referred to as clinical trials, clinical studies, research studies and trials. Clinical trials are essential in discovering safe and effective new treatments and preventative therapies for diseases. Treatments can be in the form of foods, cosmetics, drugs or natural health products. Participants are necessary in research to facilitate this discovery and the resulting research may lead to a new treatment or therapy.
Clinical trials can be either intervention studies or observational studies. In intervention studies researchers administer a treatment to participants under controlled conditions and then measure its effect on the health outcome or quality of life, either as a treatment or as a prevention. In an observational study researchers do not administer a treatment to participants or intervene in any way; they simply observe the participants and then draw conclusions about the health outcome based on what they see.
At Nutrasource, we conduct clinical trials for natural health products (dietary supplements in the United States), foods and beverages, cosmetics, medical devices and pharmaceuticals. Our experienced clinical staff have completed numerous studies in a wide range of indications including studies on cardiovascular health (including cholesterol and blood pressure), bone health, gastrointestinal health, immunology and allergy studies, glycemic index/glycemic response, joint pain, antioxidant status, skincare and bioavailability of ingredients.
We only recruit for studies once they have been approved by an independent Research Ethics Board (REB). 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 research study, you will be given complete information about the study. This is known as “Informed Consent”. The informed consent form provides a potential participant with a summary of the research project including the purpose, procedures, benefits and risks. The document will also explain the individual’s rights as a participant. The informed consent process will also consist of conversations between the research team and the participant. The informed consent process provides participants with ongoing information to help them make a decision whether to begin or continue participating in a clinical research study. The informed consent process also provides participants with an opportunity to ask questions about the study and their participation. Should you want time to review the informed consent, you will be given a copy of the document so that you can take it home, review it as many times as you need, and discuss it with family, friends, social workers, clergy, a patient representative, or other trusted advisors before agreeing to participate in the clinical trial.
As a participant you are a partner in the research study. You always have the right to continue to ask questions and get answers at any time during your participation in a trial. It is part of the researcher’s job to help answer your questions and help you understand anything that may not be clear. Typical contents of an informed consent form include:
- Purpose of the study
- Study procedures and visit frequency
- Subjects' responsibilities
- Possible risks
- Possible benefits
- Alternative therapy
- Right to withdraw from a study
- Reimbursement of expense
- Contact information
The clinical study process depends on the kind of study being conducted. As you might expect, your health status at the beginning of the study is carefully assessed in most cases. Specific instructions for participating in the trial are provided and in general, the research personnel will make sure that you follow these instructions. You will be monitored carefully during the study and in some cases research personnel will stay in touch after the active part of the study is completed. For example, you may receive an investigational product for a period of time but then you must be observed for a much longer period of time after the product has been stopped, in order to understand how it has affected your health. Many clinical studies involve more tests and doctor visits than you would normally have. These visits and tests have been carefully determined in order to ensure that the maximum amount of information can be gained from the clinical trial.
It is important to note that in many clinical studies, patients will be randomly assigned to receive different treatments, or to receive a mock treatment (placebo or sugar pill). Participants usually won’t know which treatment they are receiving, and in some cases, their physician will not know either. These are called “double-blind” studies, and they are designed to eliminate the potential effects of human bias on the results.
The benefits to participating in a clinical study may vary by study and participant. In some cases your health or quality of life may or may not improve. You will receive care from a research team that includes health professionals and investigational products not widely available that have been reviewed by many people including Health Canada. You will also have the satisfaction of contributing to medical knowledge or helping identify possible new therapies.
The length of study may vary from a single day to studies that may last months or a year. 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 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.
You will be compensated based on the time spent in the clinic and the number of visits required. The compensation varies for each study. In the event that you cannot complete a study, you will be compensated proportionate to the time you did complete.
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 Nutrasource on behalf of the clinical trial Sponsor at no expense to you. At Nutrasource 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
Individuals are treated as volunteers, meaning that there is always the option to drop out of a study 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.
As part of the clinical trial application submitted to Health Canada, the Qualified Investigator (QI) must be identified who will oversee the medical care and medical decisions which occur during the clinical study. The QI will review your health status prior to you receiving study product and will review medical information as the study progresses (e.g., blood results, side effects, medication usage, etc.). The QI must be a physician or dentist and have a current and valid license to practice medicine or dentistry.
For study related care, you will receive oversight from our study team and the Principal Investigator who is a licensed MD here in Guelph. You will continue to see your own primary care provider/general practitioner for your standard medical care. Depending on the study you are involved in, information may be shared, with your permission between your primary care physician and our study doctor. Further information will be included in your study specific informed consent form.
Many trials are randomized and double-blind. This means that you will be randomly assigned to a group by chance (like flipping a coin) and neither the research staff nor you will know what treatment you will receive. The purpose of this is to minimize bias in the study from conscious or unconscious factors.
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 behave 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 superiority studies, respectively).
Generally, once the study has been completed and researchers have completed analysis of the data collected, the study will be unblinded (researchers will become aware of what subjects received which treatment(s)). Once this occurs, we will inform participants which treatment they received during the study. Unfortunately, this cannot be done before all volunteers have completed the study and analysis of data is complete, as it could jeopardize the research/clinical trial. Clinical research is built on integrity of its data, and unfortunately it can take a long time to complete in some cases.
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, 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 Nutrasource 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 vary based on the purpose of the study. In most cases blood is collected for determination of health status, and is also sometimes used to determine specific changes in response to a therapy. In some gastrointestinal studies, we may ask participants to collect stool (fecal) samples. Urine samples may also be required for studies investigating kidney health or metabolism. During the initial screening process you will receive specific details on the types of samples to be collected during the study.
Each study is different and not all studies require blood to be taken. During the recruitment and screening period you will be informed if blood will be collected and the amount that will be taken for the specific study. The amount of blood taken is generally small but will vary by study. The amount of blood taken over the study period is reviewed by the independent ethics board to ensure your safety. The number of times blood will be drawn over the study will also be specific to the study. Some studies may require blood to be drawn by venipuncture (similar to when you go for a blood test) or with a catheter (usually during bioavailability studies where multiple blood draws during a single visit are required). You always have the option whether or not you wish to participate in a study and will be informed about the total amount of blood required and frequency (how often) blood will be drawn. Your blood will only be drawn by qualified personnel (e.g., nurse or phlebotomist).
Confidentiality is an important part of clinical research and ensures that only those people that are authorized have access to your personal information. All records relating to your identity and study participation are confidential as per the Personal Information Protection and Electronic Documents Act (PIPEDA). Nutrasource uses several safeguards to protect your personal information. Some of these safeguards include limited access areas, locked offices and cabinets, computers with passwords and firewalls, and staff training. During a study you will be given a subject ID. This ID will be used on all data so that your personal information is not kept with your study records which may include medical information. When the study is complete the results will be summarized. You will not be identified individually in any study summaries.
When we are looking for healthy volunteers, we are usually looking for participants who are not currently taking medications (women on birth control are usually accepted), and have no major medical conditions (e.g., asthma, diabetes, cardiovascular disease, etc.). The screening process may include a review of age, height, weight, blood pressure, and blood and urine samples may also be taken to determine your health status. This is similar to an annual physical examination.
Pregnancy testing is required on all women of child bearing potential for all studies where an investigational product will be tested. Females who are pregnant, lactating, or unwilling to use approved methods of birth control are not able to participate.
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. This may vary for each study design. Make sure you understand how flexible these scheduled days are when deciding to enroll in the study, as some studies are more restricted than others.
Some studies may require you to stay in the clinic for several hours. During these studies, your meals and snacks will be provided. Meals and snacks will be designed for the study. You may not eat your own food while in the clinic.
Our clinical trials theatre has 10 reclining chairs each with their own personal television with satellite. We ask that you bring your own headphones so that you do not disturb other participants. You are also welcome to bring your own laptops (free internet access), portable DVD players, or gaming systems to connect to the television. You will need to bring your own HDMI cable to connect your device to the screen.
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. Not everyone may qualify for a study; this does not mean that you may not qualify for another study. If we feel that you may qualify for another study, we may contact you to book a screening.
Visitors, guests or pets are not permitted in the clinic. This is for everyone’s protection and privacy.
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 in the University of Guelph Research Park on Stone Road. Click here for detailed directions