Clinical trials, also known as medical research studies, are carefully designed tests that assess the safety, effectiveness, and benefits of potential new treatments administered under the supervision of a physician.
What do the terms ‘First-In-Human, Phase I, and Phase II’ mean?
Clinical trials involve several phases of a potential new treatment’s development, including:
- Phase I: Testing the safety of a new treatment, and learning about early signals of effectiveness.
- Phase II: Testing the effectiveness of a treatment, often in a specific setting of cancer (newly diagnosed breast cancer, for example).
- Phase III: Comparing the new treatment to the current standard of care – these are often randomized and blinded studies.
- Phase IV: Following the drug after it is licensed and approved by the U.S. Food and Drug Administration (FDA) to track its safety and gain more information about its risks, benefits, and optimal use.
First-in-human means that it is the first time the drug has been tested in humans and that, up to this point, the drug has only undergone laboratory and animal testing.
Why should I enroll in a clinical trial?
- Being in a clinical trial gives you the opportunity to receive therapy that may be more effective or better tolerated than therapies that are currently available.
- Another benefit to enrolling in a clinical trial is that it gives you the opportunity to help future generations of patients. Every treatment and drug that is currently used had its beginnings in a clinical trial, with patients who were willing to help science find new and better ways to treat disease.
- You will be closely monitored while being on a clinical trial, which will give you security knowing that your symptoms are being thoroughly observed by experts in the field. Participation on a clinical trial also allows you to develop relationships with the research team who can help guide your treatment, answer your questions, and make sure you are involved in your care.
What happens if I am interested in a clinical trial?
- If you are interesting in pursuing a clinical trial as part of your cancer therapy, one of the first things you will do is obtain an Informed Consent Form, which provides a detailed description of the study, any possible risks and benefits of participating, and information about any financial obligations you may incur by participating.
- Your physician and research staff will make sure you are completely educated before the trial begins and answer any questions you may have before and during the trial, including:
- What is the purpose of the trial? Why do researchers believe this treatment may work?
- What kinds of tests and treatments are involved in the trial?
- What are the possible risks or side effects of this treatment?
- How will the trial affect my daily life?
- Do I have to pay for any of the treatments? What costs will my health insurance cover?
- If I benefit from this intervention, will I be allowed to continue receiving it after the trial ends?
- Who will oversee my medical care while I am participating in the trial?
What should I expect on a clinical trial?
Once you have consented, you are enrolled on to the clinical trial.
- There is a lot that happens during the trial process, but your physician and trial specialist will be in constant contact to walk you through before, during, and after your treatment so that you fully understand what is happening throughout your therapy.
- You will meet with a wide array of clinical professionals who will monitor your progress throughout the trial. This may include blood work, performing electrocardiograms, as well as administering both oral and IV drugs, as needed.
- When you come in for routine treatment, you will meet with your physician and trial specialist to gather any side effects and review symptoms that you may be experiencing, report any medications that you have taken and when you have taken them, and even fill out things like Quality of Life Questionnaires, which simply asks about lifestyle changes while on treatment.
- Your physician will treat your specific disease throughout the entire process, and if there is a point where it no longer make sense to continue the treatment, your physician will stop and begin to use different therapies.
- Clinical trials are completely voluntary. You can withdraw at any point and it will not have any effect on your medical care. If you do decide to withdraw from a clinical trial, your care team will ensure that you are receiving medical care and will pursue other options.
Clinical trials are a crucial component to developing new therapies both to benefit our current patients and our patients in the future, and allow us to take the next step in the fight against cancer.