What are the benefits of participating in a clinical trial?
By participating in a clinical trial, you not only gain access to cutting-edge & expert care, but you are participating in a potential medical breakthrough that could help many more people in the future. During treatment, you will be monitored closely by top physicians and researchers. Should the medical treatment being tested in the clinical trial be effective, you will be one of the first people to reap the benefits before it is released to the public.
What are the “phases” of clinical trials? What do they mean?
Phase 1: In this phase, the safety and dosage levels are determined by a small group of healthy participants. This phase examines how the drug is metabolized, how it interacts with other medications, how different dosages affect the body, and what side effects it causes.
Phase 2: In this phase, a larger pool of participants with more specific conditions is tested to determine the proper dosage and the efficacy of the treatment. The participants may be divided into two groups where one group receives the drug and the other receives a placebo (which could be a sugar pill or the current standard treatment). This is done to provide researchers with data that shows them how the drug, or treatment, affects the participants in comparison to normal or no treatment. These trials are often blinded, so neither the researcher, nor the participant know who is receiving the experimental drug.
Phase 3: A new and wider demographic is selected to test the long-term effectiveness of the drug during this phase. The drug is also compared to other treatment options and medications to ensure that it meets, or exceeds, the previous standards of effectiveness. This phase includes the largest number of participants and also occurs over multiple years to solidify the effectiveness of the drug. Following the conclusion of Phase 3, the drug goes to the FDA for approval. If it is found to be significantly effective in the participants, it will be offered to the public.
Phase 4: After the treatment is approved by the FDA and put on the market, the drug continues to be evaluated for side effects that were not apparent in Phase 3. This phase studies many patients and their overall quality of life resulting from the drug.
What are the commitments of participating in a clinical trial?
While participating in clinical trials, the biggest commitment is your time. Balancing routine clinical checkups, going to primary care physician appointments, and following the study protocol are commitments you may have during a clinical trial. Clear communication between physicians and patients is extremely important throughout the clinical trial, as is commitment to the treatment schedule.
Who can I talk to if I want to learn more about clinical trials?
You can always talk to the doctor treating your kidney disease or the principal investigator of the study to learn more information about whether you qualify for a clinical trial, or what the requirements may be for a specific trial.
What if my condition worsens during a clinical trial?
Patients that are participating in a clinical trial are constant care by expert doctors and researchers who make the health and safety of the patient their priority. Constant communication and regular check-ins between the patient and the researcher are highly encouraged. If you do not feel well at any point during the trial, talk to the research team and your physician immediately to decide what the best next steps are.
What is informed consent?
Informed consent is the process in which a person learn the ins and outs of the specific clinical trial for which they are interested in and agrees to participate. Informed consent starts with an open conversation between the participant and the research team. The team reviews the process of the trial to ensure that the patient understands all of the benefits and the risks of the clinical trial. The participants may ask as many questions as needed in order to reach an informed decision about what path to take.
What happens when the study is over?
After the study is completed, the data is then collected, analyzed, and shared with experts and several government agencies for the drug approval process.
Participants can continue to take the medication, should it help, but they are not required to continue with any other phases of the trials. Each clinical trial has a different set of rules about what happens after the trial is over, so be sure to talk to your research team.
How is my privacy protected?
As much as possible, your identifiable information (name, birth date, address, contact information, etc.) is kept private from most members of the research team. No identifiable information is shared outside the research team without your knowing consent. Only authorized staff members of the research team can view the data at any time during, and after, the clinical trial. Privacy policies of the clinical trial are described the informed consent document.
What should I consider before agreeing to participate?
Talk to your doctor treating your kidney disease to determine whether a clinical trial is the right plan for you. Participating in clinical trials is important for medical breakthroughs in offering new, and better, treatment options for future generations.
Is there a cost to participate?
Usually, there is not a cost to participate in a clinical trial. Prior to agreeing to participate, speak to your doctor, research team, and insurance provider to make sure the clinical trial is right for you. Participants may also be eligible for travel cost reimbursements through the sponsor of the clinical trial.