Objective: Identify potential drug compounds and assess their safety and biological activity.

Preclinical Research: These are laboratory experiments and animal studies that evaluate the drug’s safety, toxicity, and pharmacological effects. In this phase, researchers gather critical data to understand how the drug behaves in living organisms and its potential benefits. Animal studies are a key component of this phase, providing insight into the drug’s safety profile before human trials.

Outcome: Data from preclinical research is compiled into a Clinical Trial Application (CTA), which must be submitted to Health Canada for review before human trials can begin.

Objective: Seek approval from Health Canada to initiate clinical trials.

Contents: The CTA includes all preclinical data, proposed clinical trial protocols, and detailed information on the drug’s composition and manufacturing process. Health Canada reviews the CTA to ensure the trials meet safety standards.

Objective: Evaluate the drug in human subjects to assess its safety, efficacy, dosage, and long-term effects (explained in detail below).

Objective: Submit clinical trial results and seek Health Canada’s approval to market the drug.

Contents: The New Drug Submission (NDS) contains the findings from clinical trials, including safety and efficacy data, as well as proposed labeling and manufacturing processes. Health Canada conducts a thorough review of the NDS to ensure the drug’s benefit-risk profile is acceptable.

Objective: Health Canada evaluates the NDS and decides whether the drug can be marketed in Canada.

Outcome: If approved, the drug is authorized for public use. Health Canada may request additional studies or information before granting approval.

Objective: Monitor the drug’s performance and safety after it is on the market. 
Activities: Continued clinical studies, reporting of adverse events, and collection of real-world evidence to track long-term safety and effectiveness. 

A clinical trial is a research study that evaluates the safety, effectiveness, and potential side effects of new medical treatments, including drugs, therapies, and procedures. Clinical trials are conducted in multiple phases to determine whether new treatments are better than the current standard of care.

Clinical trials are essential for the development of new treatments for diseases like multiple myeloma. They provide crucial data on how effective and safe a treatment is, and help improve patient care by advancing medical knowledge.

Clinical trials are divided into four phases:

• Phase I: Tests the safety of a new treatment in a small group of participants, focusing on dosage and side effects.
• Phase II: Assesses the treatment’s effectiveness while continuing to monitor safety in a larger group of patients.
• Phase III: Compares the new treatment to the current standard of care in a larger patient population, looking at both effectiveness and side effects.
• Phase IV: Occurs after the treatment is approved and marketed, focusing on long-term effects, risks, and benefits.

The drug development process starts with preclinical research, where a potential treatment is tested in the laboratory, including on animals, to evaluate safety before it moves on to human testing. After promising preclinical results, the drug enters clinical trials (Phase I-IV), which are highly regulated by Health Canada to ensure patient safety and the scientific validity of the research.

Participants in clinical trials may:

• Access new and innovative treatments not yet available to the public.
• Receive close monitoring and high-quality care from research teams.
• Contribute to medical research that could improve treatment for future patients.

Clinical trials are designed with strict safety protocols and are overseen by regulatory bodies like Health Canada and independent ethics committees. While all treatments have risks, these risks are closely monitored, and participants are fully informed of potential side effects through the informed consent process.

Informed consent is the process by which participants are given detailed information about the clinical trial, including its purpose, duration, procedures, risks, and benefits. This allows individuals to make an educated decision about whether to participate in the trial. Participants can withdraw from the trial at any time without penalty.

Each clinical trial has specific eligibility criteria based on factors such as age, medical history, type of disease, and treatment history. These criteria ensure that the trial’s results are scientifically valid. Your doctor or research team will determine whether you meet these requirements.

Yes, participants can withdraw from a clinical trial at any time, for any reason. Choosing to leave a trial will not affect your standard medical care or your relationship with your healthcare provider.

In some trials, participants may receive a placebo, especially if there is no existing standard treatment. However, in cancer trials, it’s more common for the new treatment to be compared with the current standard treatment, rather than a placebo.

Typically, participants are not charged for treatments, tests, or procedures that are part of the clinical trial. In many cases, travel expenses or other costs may be covered. The research team will provide details about any costs or compensation.

Your doctor or a research organization can help identify suitable clinical trials. You can also search for trials through platforms like ClinicalTrials.gov or Health Canada’s Clinical Trials Database.

After a trial ends, the data is carefully analyzed to determine the treatment’s effectiveness and safety. Participants are usually informed of the overall findings, and in some cases, patients may be able to continue receiving the treatment if it has been effective for them. Researchers also share the results with the broader medical community to improve future patient care.