CLINICAL TRIALS FAQ
Q1. What is a clinical trial?
A. Clinical trials can have four phases. Phase 1 is the first use of a new drug (or use of an approved drug in a new disease) in humans. New drugs that have not yet been approved by the FDA are referred to as Investigational Products. The Phase 1 study's purpose is to test for safety and side effects and to determine how the drug should be administered. A limited number of patients or healthy volunteers are accepted to participate in Phase 1 trials.
If the investigational product is shown to be safe in Phase 1, then the company may start a Phase 2 trial to investigate an ideal dosing range of the drug. Phase 2 trials enroll a larger number of patients to determine how well the new therapy may work and whether there are side effects.
In Phase 3 trials, treatments are often compared to standard therapies, or in some cases to placebo (no active substance). Patients participating in Phase 3 trials are often randomly chosen to receive the trial drug treatment and/or a standard therapy or placebo. Patients selected to receive standard therapy or placebo are referred to as the control group. Phase 3 trials are designed to determine if the experimental therapy is better than placebo or adds benefit to the standard therapy.
In some cases, a Phase 4 clinical trial may be conducted to continue evaluation of the safety and efficacy of therapies that the FDA has already approved.
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Q2. What are the risks and benefits of participating in a clinical trial?
A. Enrolling in a clinical trial can offer many benefits. Your participation could help others by adding to the knowledge about a disease and available treatments. In a clinical trial, you could be one of the first to experience positive results from an innovative therapy. You may however experience side effects not seen with standard treatments. Instead of receiving the study drug, you could be placed in a control group receiving placebo or the standard treatment. Consider these risks and benefits before you decide to join a clinical trial.
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Q3. What are the rights of clinical trial participants?
A. Clinical trials are regulated by governing groups to protect patient safety and scientific research ethics. Clinical trial patients' rights are protected by the Institutional Review Boards (IRB) of participating institutions, peer or scientific review of the protocol, and the Informed Consent process.
Institutional Review Board (IRB). Research organizations have an Institutional Review Board (IRB) set up to oversee actions and documents related to each clinical trial. The IRB is composed of medical specialists, nurses, social workers, medical ethicists who do not have a special interest in a specific trial. Each member is responsible for ensuring that the clinical trials are conducted in a safe, fair and ethical manner and with full patient consent and involvement.
Peer Review: Experts such as the National Cancer Institute, or a pharmaceutical company chosen by the study sponsor, often review clinical trials. These groups review trials before submission to an IRB for patient safety, ethical considerations and scientific merit.
Informed Consent: Informed Consent is a process designed to inform a clinical trial patient and to encourage good communication between the patient and the research team. Informed consent ensures that the patient is provided with information about safety issues that could surface during the study. Patients interested in participating in a clinical study meet with a member of the study research team to discuss the trial and provide written information, called the Informed Consent document, which will provide facts such as the purpose, required procedures and risks and benefits. After this meeting, the patient is given time to read the document. Once a patient decides to join a trial, they are asked to sign the document and verify that they understand and agree to the conditions. Patients should keep a copy of the Informed Consent document for future reference. If significant changes are made to the study design or if serious side effects are seen, the patient could be asked to re-sign the Informed Consent document.
Informed Consent rights continue after a patient enrolls in a trial. A healthcare team will evaluate how the study treatment affects patients; participants are encouraged to ask questions of the team. Participants may leave a trial at any time and for any reason.
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Q4. How will I know if I should participate in a clinical trial?
A. For a better understanding of the risks and benefits of clinical trials, talk with other patients who have participated in one. Discuss potential side effects with your doctor. If you find a trial that could be helpful, remember that participating in a trial requires a time commitment for the treatment, monitoring and follow-up procedures.
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Q5. Are there questions I should ask my doctor?
A. A. Ask your doctor questions about clinical trials. Before entering a clinical trial, you should have answers to questions such as these:
- What is the purpose of the study?
- Who is the clinical trial sponsor?
- What are the eligibility requirements for entering the trial?
- What are the risks involved during and after the study?
- Will I be in any discomfort or pain?
- What kinds of tests and procedures will be performed?
- What are the chances I will be placed in a control or standard treatment group?
- Will I be able to see my own doctor during the trial?
- How long will the trial last?
- Is there a contact person I can call with other questions?
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Q6. Is there a cost to participate
in a trial?
A. Often, patients and the trial
sponsor pay for clinical trial treatment
costs. Patients may pay for routine costs,
such as doctor visits, hospital fees,
and lab tests. These costs are incurred
as a part of routine treatment, whether
you participate in a trial or not, and
may be covered by health care insurance.
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Q7. How can I enroll in a clinical
trial?
A. Patients may enter a trial under
their doctor's guidance or if they are
referred from another institution.
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Q8. Where can I find more information
about the investigational products you
have in clinical studies?
A. More information is available
about ZymoGenetics' product candidates
at: http://www.zymogenetics.com/products/product-candidates.php
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