Frequently Asked Questions

Understanding Clinical Research

What is a clinical research study?

A clinical research study, also called a clinical trial, is a carefully controlled research project that helps evaluate a potential new medication. Clinical research studies typically test the safety and effects of investigational medications and treatments. However, clinical research studies can also involve researching new uses and new applications of existing drugs. Clinical research studies are essential. Every new medicine must go through the clinical research process before it can be approved for use.

What is a Phase I or Early Phase Study?

After a new drug has been successful in animal (pre-clinical) studies, it is ready to be tested in humans in a Phase I or Early Phase study. Initial human testing is usually done in a small group of healthy volunteers. The main objective of first-in-human studies is to determine the safe dosage range for administering the drug, as well as how the body absorbs and eliminates the drug.

Other early phase trials look at bioequivalence. Are two drugs with the same active ingredient equal? These studies are essential to show that a generic version and a marketed/brand medication are the same. To test this, measurements of both the new and marketed drug are performed generally through blood or urine samples. Bioequivalence studies also look at the safety and possible side effects of the drug(s) being studied.

What is an abuse liability study?

The objective of these types of studies is to determine the potential for abuse or misuse of an investigational drug. These studies rely on the experience of volunteers who already use similar drugs recreationally to provide insight on the "abuse potential" of a new drug.

Who can participate in a clinical study?

Clinical studies can be conducted in volunteers who have a specific disease or health condition to see if the investigational drug works for their disease or condition

Alternatively, healthy volunteers can participate in clinical studies. These types of trials may be investigating the safety and/or efficacy of a drug.

All clinical research studies have inclusion and exclusion criteria that determine if it is safe for a volunteer to participate. Volunteers typically undergo a physical examination and answer some questions about their health and medical history to determine if they are eligible to participate.

What are the benefits of participating in clinical studies?

There are many benefits to participation, including

  • helping others by contributing to medical research
  • obtaining expert medical care and attention during the study
  • becoming active in your own health
  • gaining access to leading-edge treatments that are not yet available to the public
  • meeting new people
  • financial compensation for some studies

An IRB (Independent Review Board) reviews and approves all clinical research studies before they begin. The responsibility of this board is to ensure that a clinical study is ethical , and the safety and rights of study participants are protected.

Screening Visit

What is informed consent?

Informed consent gives volunteers information about a clinical research study so that they can make an informed decision to participate in a study. The informed consent process ensures that volunteers can get answers to questions about the study and be comfortable about the nature of the study in general.

The informed consent form provided at the screening visit will give you information about the procedures, risks, and benefits of the clinical research study. You will be given time to read and consider the information given to you. Once you are ready, the study staff will review the informed consent form with you and discuss the study medication(s) along with the details. You will be encouraged to ask questions about the study, and the study staff will do everything they can to clarify and address any of your concerns. The study staff will also ask you questions to make sure you understand and are comfortable with the study and its procedures. The final choice is yours. You will be given time to think over the study details and make a decision before signing the informed consent form.

Study Schedules

How long will the study be?

The length of the study depends on the type of research. Clinical studies can be conducted on an inpatient and/or outpatient basis. The scheduled visit dates and times will be provided to you at the initial telephone contact with the Recruitment department.

Clinic Environment

Accommodations

Our modern facilities are specifically designed to provide our volunteers with a comfortable stay especially for those studies that require overnight and long duration stays. We have 4 newly decorated lounge areas to provide our volunteers with a feeling of "home away from home". For overnight and long duration stays, we have 8 separate bedroom areas with 8 to 12 beds and bathrooms equipped with showers.

Meals

The meals and snacks are provided for all in-clinic stays and for some outpatient studies depending on the study type and duration. We strive to provide our volunteers with nutritious meals and snacks daily. We selected caterers that prepare fresh, healthy meals using local high-quality ingredients. Among the external caterers that we use are Essential Meal Delivery headed by chef David Greensmith, who is a personal chef to NHL players, and visiting celebrities such as Abbie Cornish and Piper Perabo.

Entertainment

Our lounge areas include large LED flat screen and Apple TVs for watching movies as well as Play Station gaming consoles for playing video games. We also have computers with wireless internet, board games (including puzzles), and a library of books available to volunteers for use during their stay.

It's important for us that our volunteers enjoy their stay at our research clinic particularly during long duration studies. In addition to our modern facilities and lounge areas, we organize a number of fun activities that include (but are not limited to) Bingo, Jeopardy, Family Feud, Poker, Arts and Crafts, Massage Therapy and Movie Nights.

What kind of staff/supervision is available at your site?

We are committed in ensuring our volunteer's safety. Our supervisory staff are all registered nurses or paramedics, trained in emergency situations. Physicians are on site during the day, on dosing days, and on-call for overnight studies. We have specialists for specific studies such as dermatologists for skin disorder studies.

Can I make phone calls during the study?

Free local phone calls are permitted during the study provided that they do not interfere with or delay any test procedures. Cell phones may interfere with the medical equipment used in the study, so please check with the clinic staff before using any wireless communication devices such as cell phones, pagers, etc.

Is smoking allowed?

Some studies permit smoking, but others do not. Smoking is not allowed in the building or for the duration of the overnight visits at our clinic. When permitted, you will be escorted out of the building by staff for supervised smoking breaks.

Compensation

How is the study compensation determined?

Clinical research involving human participation includes compensation for the time and inconvenience of volunteers. The amount is dependent on the number of visits and the complexity of the study.

Volunteers may incur expenses from participating in clinical studies such as transportation costs, meals, or out-of-pocket expenses. Financial compensation may be provided in such cases.

When do study participants receive their compensation?

Many studies provide compensation to the participants at the follow-up visit. However, other schedules of payment may also be used and will depend on the type of study being done.

Safety

What happens if I have a reaction to the drug?

At INC Research Toronto, our volunteers' safety is paramount. However, any time a medication is used, side effects are possible. If a side effect does occur, physicians and registered nurses are always on site. Common side effects will be discussed during the first visit as part of the informed consent process.

Confidentiality

Are the studies confidential?

Your privacy is important to us. Personal information will not be shared with any external party without your informed consent. We have a very stringent Privacy Policy which can be provided to you at the screening interview or you can download here.