Frequently Asked Questions About Clinical Research
Every day, all across the world, new treatments, medicines, and medical procedures are being developed and researched. These drugs, devices and medical innovations ease pain, heal and make life better for hundreds of thousands of people. However, before these new medical devices can be used and often life-saving medicines can be offered to the public, to answer scientific questions, studies must be conducted so we can gauge the safety and effectiveness of drugs and other therapies. This clinical research is one of the final stages in a long and careful research and development process.
To help you understand and to arm you with knowledge that can be useful, CRTSolution has answered some of the most frequently asked questions about clinical research.
1. What is a clinical trial?
A clinical trial is a research study conducted on human beings with the goal of answering specific questions about new therapies, vaccines or diagnostic procedures, or new ways of using known treatments. It is intended to add to medical knowledge.
2. What are the phases of clinical trials?
The clinical trial process was historically divided into 3 phases: Phase I, Phase II and Phase III. Phase 0 trial is an exploratory study (a microdosing step to identify viable drug candidates).
Phase I consists of tests and experimental treatment on a small group of often healthy people to judge its safety and discover side effects and also to determine the correct drug dosage. Phase II uses more people, and the emphasis is on effectiveness. Phase III is designed to gather more information about safety and effectiveness, studying larger, different populations, different dosages, and uses the drug in combination with other medications. Finally, phase IV tests the device or drug’s effectiveness. Safety is monitored in large, diverse populations once approved by Health Canada or the FDA.
3. Who can participate in a phase III trial?
Participants who have the condition that the new medication is meant to treat are usually the best choice to evaluate how the new medication works in comparison to existing medications for the same condition.
4. What happens when a clinical trial or study ends?
The researchers will collect and analyze the data to get more information about the medication’s long-term safety, effectiveness, and any other benefits. If the remedy is deemed effective, regulatory bodies can then grant approval, and the device or medicine will then be permitted to go to market.
5. What should you consider before participating in a clinical trial?
As a participant, you should inquire about the purpose of the trial, find out how long the trial lasts, possible risks, side effects and benefits, and be informed of what kinds of tests and treatments are involved. Additionally, you should consider how the trial might affect your daily life, if hospitalization will be required and if you will be kept informed about the study results.
If you have any more questions about clinical research, get in touch with the experts at CRTSolution. Formed and incorporated in 2020 by a collaboration between International Clinical Research Academy (ICRA) and Delva Consulting Inc., we are a company that specializes in clinical research training and certification. Our main goal is to assist researchers (study sites) by providing personalized, hands-on training designed to improve the rate at which newly hired staff become qualified and fit for clinical trial activities. We offer in-person training across Quebec and virtually across the rest of Canada and North America.