Saturday, May 25, 2024

FAQs: Clinical Trials

Every drug – from a basic pain reliever to a powerful anti-psychotic medication – must first undergo a series of clinical tests before being approved for use.

Thinking about joining a clinical trial?

Read the frequently asked questions from our participants, because we believe in the importance of making an informed decision about your health.

What is a clinical trial?

A clinical trial is a medical research study that investigates the capacity of a particular drug to treat human conditions and diseases.

Clinical trials follow protocols that clearly define what the trial is investigating (e.g. how effective 5 mg of drug A is in reducing blood pressure), and how the study should be conducted (e.g. drug A is administered orally every morning at 8 am and blood pressure is measured every evening at 4 pm).

Clinical trials are designed to determine if the drug under investigation would improve outcomes (e.g. lowering blood pressure) while ensuring patient safety.

How is my safety ensured while involved in a clinical trial?

Every clinical study is executed under the supervision of a medical doctor (also known as a Principal or Qualified Investigator) and qualified medical staff who are trained in research ethics and safety (i.e. a certification in Good Clinical Practice).

All studies are also monitored by ethical and legal regulatory bodies such as Health Canada that ensure patient well-being.

Why should I consider participating in a clinical trial?

Clinical trials seek to discover innovative treatment options for various medical conditions. Individuals who participate in clinical trials are often those who have tried available treatment options unsuccessfully.

By electing to participate in a clinical trial, you are electing to further develop the treatment of a given medical ailment.

As a participant, you are afforded the opportunity to be more attentive to your health while aiding the progression of medical research.

Is it possible that I will experience side effects from the medication under study?

Side effects are a possibility for drugs that have been on the market for years like Tylenol or Advil, and are not just a reality of clinical trials.

It is important to note that clinical trials minimize the chance of side effects through a rigorous screening process and that any side effects caused by investigational medications occur in an environment of regular medical monitoring and priority access to healthcare professionals.

What is informed consent?

Participants are asked to provide informed consent for participation to indicate that they understand and consent to the treatment process, and risks and benefits associated with the clinical trial.

The process of informed consent provides you, the participant, with the opportunity to ask questions about the intervention and to gain more knowledge about your condition.

It is worth recognizing that informed consent is an ethical consideration and is NOT a contract to participate in. Participants are free to withdraw from the trial at any point.

Will I be compensated for trial participation?

In addition to receiving potentially beneficial treatments, clinical trial participants often receive monetary compensation for their time and any expenses associated with participation.

The amount of compensation is based on multiple factors, such as duration of visit, travel time, and frequency of follow-up visits.

As a result, phase I trials are often associated with greater compensation as they can involve overnight stays at the clinic.

What is a Placebo?

A placebo is a mock medication (often in the form of a sugar pill) that has no therapeutic effect on the body.

It is common for patients who take a placebo to feel better and to have physical improvements in parameters such as blood pressure when they believe that they have taken medication.

Referred to as the placebo effect, this phenomenon is thought to arise from the strong connection between the body and the mind (e.g. if you think that you are going to feel better, you tend to feel better and show physical signs of improvement).

As the placebo effect makes it difficult to assess whether or not the medication under study is working, some participants are given placebos strategically.

Since both placebo and non-placebo groups are treated identically (e.g. they follow the same schedule and undergo the same assessments), investigators can measure the effect of the medication by canceling out the placebo effect.

What are the different phases of clinical trials?

There are phases of research that a drug must go through before approval:

0Purpose:  Also known as ‘Exploratory Studies’, phase 0 trials can be thought of as early phase I trials with the purpose of weeding out ineffective drugs within a very short time frame (typically less than 7 days) using minuscule amounts of the agent. Phase 0 trials are not mandatory but are meant to accelerate the development of anti-cancer treatments. This phase does not determine safety but what the body does to the drug and what the drug does to the body.

Participants: Healthy volunteers or cancer patients, depending on the trial.

Size: Typically fewer than 10 participants.

IPurpose: Phase I marks the transition from animal testing to clinical testing (except for cancer drugs that undergo phase 0 trials). The dose-specific chemical and biological effects of the drug (including undesirable and adverse effects) are observed and noted. Primarily, this phase is used to determine safety, including whether or not it is safe to move forward to phases that test the effectiveness of the product.

Participants: Healthy volunteers or patients with the condition under investigation, depending on the trial.

Size: Approximately 20-80 participants.

IIPurpose: The effectiveness, side effects, and risks of the drug under investigation are assessed in phase II trials. The safety of the drug is also evaluated. These trials can last several years.

Participants: Patients with the condition under investigation.

Size: Approximately 100-300 participants.

IIIPurpose: In phase III trials, the effectiveness and side effects of a drug are compared to the ‘gold standard’ (i.e. best available treatment). Phase III trials provide pharmaceutical companies and regulatory bodies such as Health Canada with additional safety information about a drug.

Participants: Patients with the condition under investigation.

Size: Approximately 1,000-3,000 participants.

IVPurpose: Phase IV trials are considered ‘after-market trials’, as they monitor drugs that have been approved for the market. They involve monitoring drug use when used in combination with other drugs and comparing it with other available treatments.

Participants: Patients with the condition under investigation.

Size: Dependent on the drug market and related factors.

Phase 0 was introduced by the Food and Drug Administration (FDA) to promote innovation and expedite cancer research in 2006.

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