To mark International Clinical Trials Day on May 20, API is highlighting the interesting work that goes into clinical trials
Clinical trials are an important and complex stage when innovators are commercializing life sciences products. They evaluate the safety and effectiveness of new treatments, diagnostic tests, and medical devices before they are approved for use by the general public.
“The first step of a successful clinical trial is a detailed plan,” says Julianna Weber, API’s Director of Clinical Affairs. “How have you designed your study? Do you have the right sample size and criteria for study participants? Does your trial design meet regulatory requirements, and has your product been made according to good manufacturing practices?”
How you use data is also essential. “For example, using data from prior studies for simulations can help you plan your clinical trials and reduce risk,” says Dr. Micheal Guirguis, API’s Director of Clinical Pharmacology and Data. “How you collect, manage and analyze your data is critical to meet your clinical development objectives and meet regulatory requirements.”
Sounds overwhelming, doesn’t it?
The solution is finding a group of experts who can help answer those questions and ensure that the clinical trial is well designed and executed. API offers innovators custom teams who can offer expertise in:
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- Protocol development
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- PK analysis
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- Biostatistics
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- Study management
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- Clinical monitoring
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- Medical monitoring
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- Clinical pharmacology strategy development
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- Medicinal chemistry and synthesis
We also provide a wide range of regulatory supports to ensure that work is done in a manner that will be compliant for regulatory bodies, from the development of an investigators’ brochure to the guidance and completion of appropriate GLP/GMP/GCP studies, to liaising with the FDA, EMA, and Health Canada.
As API implements the Canadian Critical Drug Initiative (CCDI) – a revolutionary project that will create a research, commercialization and manufacturing hub in Edmonton – API’s ability to help innovators will be greatly enhanced as we expand support for Phase III clinical trials.
Here’s some more information and provincial resources for clinical trials in Alberta:
Learn more about how you could participate in a clinical trial in Alberta:
The 4 phases of clinical trials:
Phase I: Is it safe?
- Involves 20-80 people.
- The first step in testing new treatments in humans.
- Evaluates the safety of the treatment, identifies any potential side effects, and determines the appropriate dose of the treatment.
Phase II: Does it do what it’s supposed to do?
- Involves 100-300 people.
- Further evaluates the safety and efficacy of a new treatment in a larger group of patients with the disease under study.
- Determines the optimal dose of the treatment and identify any potential side effects or safety concerns
Phase III: Does it work better than existing treatments or approaches?
- Involves 1000-3000 people.
- Large-scale trials that involves hundreds or thousands of patients with the disease under study.
- Provides more evidence of the safety and effectiveness of the treatment, and compares the treatment to existing treatments or a placebo.
Phase IV: How does it work over the long run?
- Conducted after a treatment has been approved by regulatory authorities and is available to the general public.
- Monitors the long-term safety and effectiveness of the treatment.
Source: itstartswithme.ca/how-it-works