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Clinical Trials Information for Patients
Participate in a clinical study and help make new treatments available.
Volunteer for a Research Study
Clinical research are trials constructed to test hypotheses about particular products and therapy options that could ultimately benefit patients in the future or current trial volunteers. Whether the investigational product is already approved or looking to become FDA approved, research studies test the safety and effectiveness of the product, and therefore are thoroughly regulated by the Food and Health Administration (FDA) requirements.
There are a number of reasons why you might want to participate in a clinical trial.
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By volunteering, you’ll know that you’ve played a role in advancing science and improving life for future generations
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Your participation could help others who are suffering from a disease or illness, or could prevent others from experiencing negative health impacts in the first place.
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Participating in a clinical trial may give you access to new, cutting-edge treatments.
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You may provide researchers information that, when anonymously combined with the data of other participants, could provide new insights into the keys to healthy aging.
We Put Your Safety First
Anyone interested in participating in a clinical trial at the Fides Clinical Research will be provided with easy-to-understand information about the goals of the study and any possible risks and benefits. If you agree to participate and are accepted in the clinical trial, you may opt out at any time.
Learn More About Participating
Read our Clinical Trials FAQs to explore some common questions about the benefits for you or a loved one in participating in a research study.
What is a Clinical Trial
A clinical trial is a research study to determine whether an experimental drug, device or treatment is beneficial to the advancement or improvement of patient care. Activities during a clinical trial are different from those of routine standard of care. Clinical trials are designed to answer several essential questions. • Is the new drug able to treat people? • If so, is it better than the drugs currently available? • If it is not better, then what are the side effects of this drug? • Is the drug safe? • There is no treatment without side effects. Do the benefits of the drug outweigh the risks?
What are the 4 phases of clinical research studies?
Phase 1: This phase typically consists of 50 to 100 healthy volunteers. During phase 1, researchers assess the drug’s safety, determine the side effects, and evaluate how the drug should be taken. Phase 2: Typically, 100 to 300 patients with the condition for which the medicine, device, product, or treatment has been developed participate in this next phase. Researchers look to assess the short-term safety and effectiveness of the drug, find the dose at which it works best with the least side effects, and conduct a small-scale placebo comparison. Phase 3: In phase 3, the pool of volunteers must be must larger. Typically, between several hundred and several thousand patients participate, so researchers can confirm the drug’s safety and effectiveness and compare the new drug to other compounds (e.g., a placebo or other therapies). Following the completion of Phase 3, a drug is approved (or not approved) by the U.S. Food and Drug Administration (FDA) for use by specific patients. Phase 4 may only begin if the drug is approved. Phase 4: Finally, after the drug is approved researchers look to study the effectiveness of the drug in a wide variety of patients as well as monitor the safety in a large group and enable the development of new uses for the compound. These studies often involve thousands of patients and can inform future research and development.
What happens in a clinical trial or study?
Here’s what typically happens in a clinical trial or study: 1.Research staff explain the trial or study in detail, answer your questions, and gather more information about you. 2.Once you agree to participate, you sign an informed consent form indicating your understanding about what to expect as a participant and the various outcomes that could occur. 3.You are screened to make sure you qualify for the trial or study. 4.If accepted into the trial, you schedule a first visit, which is called the “baseline” visit. The researchers conduct cognitive and/or physical tests during this visit. 5.For some trials testing an intervention, you are assigned by chance (randomly) to a treatment group or a control group. The treatment group will get the intervention being tested, and the control group will not. 6.You follow the trial procedures and report any issues or concerns to researchers. 7.You may visit the research site at regularly scheduled times for new cognitive, physical, or other evaluations and discussions with staff. During these visits, the research team collects data and monitors your safety and well-being. 8.You continue to see your regular physician(s) for usual health care throughout the study.
What are my responsibilities if I am enrolled into a Clinical Trial?
• Read the inform consent and other documents carefully. Ask questions about the study and make certain that you fully understand the risks and benefits of the study. • It is important to adhere to the guidelines set forth in the protocol, such as the duration of the study, report any potential side effects, and inform the research team of any changes. These guidelines will be discussed with you by the Principal Investigator and Clinical Research Coordinator who are responsible for conducting the clinical trial.
How often will the participant have to visit the clinic to undergo examination during the study?
The schedule of clinic visits is developed individually for each clinical trial and will be detailed in the informed consent form (ICF). In some cases, the participant needs to see a doctor several times a week, especially at the beginning of the trial, while other studies, visits can be no more than once a month. Therefore, it is vital to become acquainted with the details of the ICF and discuss any concerns with the research team.
What are the risks and benefits of taking part in a clinical study?
If you are interested in participating in a specific study any potential risks will be explained to you before you give your consent to participate. You will also be able to discuss any concerns you may have with a member of our medical team.
Are clinical trials safe?
Your safety is our number one priority. Drug development is highly regulated with strict safety and ethical guidelines, and we take those regulations very seriously.
Will my information be kept confidential?
Our staff respects your privacy. No information will be given out about your participation and/or your medical information unless required by law. For example, the sponsor, regulatory agencies, or an independent review board may inspect your clinical research study medical records. This may include your name, address or other information that identifies you. If necessary, some or all your records may be copied during these inspections. Because of this, absolute confidentiality cannot be guaranteed. The results of the clinical study may be presented at meetings or in publications. However, you will not be personally identified in any presentations or publications.
Where can I find a clinical trial that fits my needs?
In many cases, your physician will be able to offer you information about opportunities to become participants in a drug trial. This is often the case if the drug’s possible effectiveness is greater than traditional methods of treatment. A great online source is ClinicalTrials.gov. This is a federally supported and searchable registry for clinical trials pertinent to your condition: www.clinicaltrials.gov Additionally, patient advocacy groups can offer helpful information about clinical trial opportunities specific to your condition.
What if I decide I don't want to participate anymore?
Our clinical studies are always voluntary. If you decide that you no longer want to participate in a clinical trial, you can do so at any time. Simply inform the research team, and they will discuss the process of withdrawal from the study. Withdrawal will involve stopping the investigational treatment and may involve proceeding to the End of Study (EOS) and follow-up visits.
Will my insurance be billed for my participation in a trial?
Your insurance should never be billed for study-related assessments.
Will it cost to be a participant in the study?
The care and investigational treatment that you receive as part of a clinical trial are provided at no cost to participants. Some studies also provide reimbursements or stipends to lessen the burden of travel to the study site, meals during clinic visits, and other expenses associated with your trial participation. In this case, the Institutional Review Board (IRB) determines the amount and schedule of all payments to participants before the start of the study to ensure that the proposed method and timing will not result in any undue influence as guided by FDA (21 CFR 50.20).
Contact
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