Frequently Asked Questions

A clinical research trial explores a new treatment or device for use in humans. They are controlled and highly regulated evaluations of the benefits and safety of anything used to treat humans or animals.

Regulatory agencies like Health Canada and the FDA require that clinical research trials be conducted when developing all new treatments, preventions, and devices for diseases or conditions. Clinical research trials are also referred to as clinical studies or clinical trials. Probity Medical Research has helped design and conduct clinical research trials since 1995.

Many people are involved in clinical research trials. Clinical research trials are funded or sponsored by government agencies such as the National Institutes of Health, pharmaceutical companies, investigators (physicians), health care institutions, and organizations that develop medical devices and equipment. Government agencies, like Health Canada and the FDA oversee and monitor the clinical research trials. Independent Ethics Committees review and approve the trials while health care workers perform the assessments.

Clinical research trials may take place at several locations or sites across the world. Trial sites can be doctor's offices, community clinics, hospitals, or universities. Probity Medical Research has trial sites in the United States, Canada, and Australia. At each site there are several members of the research team who will work with study participants, including doctors, nurses, and clinical research coordinators.

Anyone. Each clinical research trial will have guidelines or criteria for who is eligible for that particular trial. The criteria are based on characteristics like age, gender, medical history, diseases, or conditions. The criteria are used to determine the appropriate participants for the trial and to ensure the safety of the participant. Some clinical research studies are for specific diseases or conditions while some are for healthy participants.

To learn about clinical research trials in your area visit Probity Medical Research's website dedicated to patients: Researchtrials.org.

Clinical research trials are divided into phases, each with specific goals. Each phase of the trial must be successfully completed before the next one is started. The Investigators who work with Probity Medical Research have participated in all phases of clinical research trials.

Phase I - TOLERABILITY

Researchers will provide the study drug to a small number of healthy participants to evaluate how well the drug is tolerated, determine safe dosage ranges, and identify possible side effects. These studies are designed to determine how the study drug functions in a human body.

Phase II - ESTABLISHING DOSE

In this phase a larger group of participants are provided with an appropriate dose over a longer period of time. Participants in this phase all have the targeted disease or condition. Researchers will evaluate the effectiveness of the study drug. They will also determine if there are any long-term side effects.

Phase III - EFFICACY

Large groups of participants over several months or years will participate in Phase III trials. Researchers will evaluate if the drug remains useful or has any side effects that show up over longer periods of time. During these studies a placebo (inactive substance) is often used to compare with the new drug.

The study drug will be used at multiple locations in hundreds to thousands of participants who have the targeted disease. These participants represent the population the drug is intended for once it is marketed.

Phase IIIb studies are also performed to gather additional safety information, evaluate the effectiveness with other diseases or conditions, and to assess a particular population such as children or elderly patients.

Phase IV - POST-MARKETING

A drug continues to be evaluated even after it is approved for use and marketed to the public. Phase IV trials are designed to evaluate any effects over several years of treatment, to compare the study drug to other marketed drugs, to review the impact on a participant's quality of life, and to determine the cost-effectiveness of a study drug.

You will be provided with an informed consent form to review and sign. When you sign the informed consent form you are telling the research team that you would like to participate in the clinical research trial. Once you agree to participate in a clinical research trial, you will enter into a "Screening" period to determine if you are eligible for the trial. During this time the clinical research team will:

• Ask questions about your current health and medical history
• Review medications you are currently using or have used in the past
• Perform evaluations to assess your condition or disease
• Determine if you are an appropriate candidate for the trial and if it is safe for you to participate

If it is determined that you are eligible to participate you will return to the study site for additional visits as directed by the clinical research team. At these visits your health and progress will be monitored. These visits may include physical exams, blood work, or specialized assessments to monitor your disease or condition. Probity Medical Research assists the researchers by making the experience more friendly and efficient.

Informed Consent Forms (ICFs) provide potential participants with detailed descriptions of the clinical research trial. The ICF will describe:

• the study procedures
• the intervention or medication being investigated
• the duration of the study
• the potential risks and benefits
• how your personal health information will remain confidential

ICFs are reviewed by Independent Research Ethics Boards to ensure the information in the form is correct.

A consent form will be presented to you by the clinical research team. You will have as much time as you need to read and review the consent form.  You may take home an unsigned copy of the consent form to discuss with family or friends before making your decision.  You should ask the study doctor or the study staff to explain any words or information that you do not clearly understand.  A copy of the signed consent form will also be provided to you. Your participation in a clinical research trial is always voluntary.

Probity Medical Research works with clinical trial sponsors and ethics committees to develop accurate and informative consent forms.

A placebo is an inactive substance. It has no medication (drug) in it. It looks the same as the real medication. In clinical research trials treatments are often compared to a placebo to determine their effectiveness. Placebos are used in clinical trials when there is no accepted standard of treatment and to determine the effectiveness and tolerability of the study drug.

Probity Medical Research has been involved with many new therapies for a range of diseases including: psoriasis, acne, prostate cancer, and benign prostatic hyperplasia (BPH). Probity Medical Research has developed a list of possible benefits from participating in a clinical research trial:

• Taking an active role in your own health care
• Thorough monitoring of your condition
• Receiving care from physicians who specialize in the treatment of your condition
• Contributing to research that may benefit others with your condition
• Access to new treatments before they are widely available

The possible drawbacks of participating in a clinical research trial may include:

• A new approach that may not work for you
• Unknown risks or side effects that the research team is unaware of
• Ineffective or less effective treatments than currently available treatments
• A greater time commitment than required for standard treatment

You will always be informed of changes throughout a clinical research trial and your condition will be monitored closely by health care professionals.

Adverse experiences or events are undesired effects that occur during a trial. They may or may not be related to the study drug. These experiences can happen when taking a medication prescribed by your doctor or while participating in a clinical research trial. The clinical research team will monitor you closely for any immediate or long-term adverse experiences.

The Investigators who work with Probity Medical Research frequently discuss experiences participants have during trials to keep each other informed.

Yes. You can leave a clinical research trial at any time without providing a reason. Withdrawing from a trial will not affect the medical care you receive now or in the future. If you decide to discontinue your participation contact the research team to let them know your decision.

Research involving humans is conducted according to strict scientific and ethical guidelines to ensure your safety. Clinical research trials are approved and monitored by an Independent Research Ethics Board and regulatory agencies like Health Canada or the FDA. The ethics board and the regulatory agency will ensure the safety and rights of the participants are protected.

Probity Medical Research's sites are frequently monitored by regulatory agencies like Health Canada, the FDA, and the European Medicines Agency (EMA).

Every clinical research trial is submitted to an Independent Research Ethics Board for approval. An ethics committee must consist of a minimum of 5 people who have specific roles in the community. An ethics committee must provide approval before any study can begin.

An ethics committee is established to ensure the rights of the participants involved in a clinical research trial are protected. The committee will review, make decisions, and provide approvals on the design of a study as well as documents affecting a participant.

Throughout a clinical trial the ethics committee will review and monitor any potential risks to the participants. An ethics committee can request that modifications be made to the study, disapprove documents, or deny overall approval for a study.

Probity Medical Research has worked with numerous committees across Canada, the USA, and Australia.