Clinical Trials 101 with Clinical Trial Facilitator Cynthia Kerr
Heralded as the best – if not the only way – to advance medicine, clinical trials are designed to evaluate new ways to prevent, detect, or treat disease. Every type of medicine used today was once the subject of a clinical trial, from aspirin to chemotherapy.
With over 345,000 active clinical trials in the world today, it is evident that researchers are tirelessly working to advance the medical field. However, clinical trials rely on voluntary participants. To help patients determine whether or not a clinical trial is suitable for them, Clinical Trial Facilitator Cynthia Kerr joined the National Foundation for Cancer Research to answer some key questions regarding clinical trials.
- What are clinical trials?
Clinical trials are studies in which voluntary participants test new drugs or treatments. They are the final stage in a very long process. Before being approved for use in a clinical trial, the treatment undergoes years of laboratory studies. These studies often begin by using cells in test tubes before being deemed safe enough to be used in animal cells.
- What are the different phases?
Depending on what is being trialed, the phases may vary. For the most part, clinical trials take place in three phases after the laboratory studies conclude.
Phase one focuses on finding the highest dose that can be administered without side effects and includes only a small number of people. Phase II uses a larger group and looks at whether or not the treatment is effective. Phase III is the final stage before the treatment can be submitted to the FDA for approval. In this final stage, researchers determine whether the treatment on trial is more effective than current treatment options.
- How do they work?
Again, each trial will vary but most will use a randomized control trial. In Phases II and III, participants are split into two groups. The control group receives standard treatment while the investigative group receives the new treatment. Then, a number of variables are tracked to see which treatment is better. These groups are completely random and neither the participant nor the researchers know who is in which group. It is worth noting that the control group, especially in regard to cancer trials, still receives standard treatment where possible. Placebos are rarely used in trials where the patient has a serious illness.
- What are the risks and benefits?
The potential risks are the most daunting aspect of a clinical trial. The treatment in question hasn’t been studied to the extent that the standard treatment option has been. This means that it may not be as effective as the standard treatment or that it may have side effects that haven’t yet been identified. These risks are quite standard amongst every trial, and the research team will always discuss risks of trial with potential participants.
As far as benefits go, there is the chance that the drug being trialed is better. That’s the reason for the clinical trial in the first place. Not only would participants play a vital role in proving that, but they may be able to greatly benefit from the treatment.
- When should cancer patients consider a clinical trial?
The priority should always be ones’ own health. If it is feasible to use mainstream treatment, doctors will almost always recommend that for patients. When current treatment options fail, there may be a trial that is suitable. Each situation is different, and patients should speak with their doctor about their options.
- Is there a cost to participating in clinical trials?
Participants are rarely required to cover costs directly associated with the trial. Trials often require additional monitoring, which means some participants will be paying for transportation and accommodations depending on where they live and where the trial is located.
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