Frequently Asked Questions
There is a lot that goes into clinical trials, so understandably, you may have some questions.
These are some of our most common questions.
What is a clincial trial? Clinical trials are research studies designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions; these may include drugs, treatments, surgical procedures, devices and behavioral or nutritional strategies. The goal of clinical trials is to determine the safety and efficiency of the particular intervention.
What do the trial phases mean? Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people Phase IV takes place after the drug or treatment has been licensed and marketed.
Are clinical trials safe? Yes! There is a multitude of oversight of any clinical trial in every stage of its phases. Oversight can be led by the FDA, study sponsor, and trial site & its staff. Always remember, you are in control of your own progression throughout the study!
Who can participate? Eligibility criteria are different for each trial. Generally, subjects are "unhealthy", but that's not always the case. Your eligibility may be based on your age, gender, overall health, type and stage of a disease, treatment history, and other conditions. Contact us for specific eligibility criteria for our actively enrolling trials!
What are my rights as a participant? Informed Consent signatures are required prior to starting any study related procedures, and you will receive a copy of the Informed Consent. You have the right to withdraw your consent at any time throughout the study.
Is my personal and medical information confidential? Your information is protected and treated with confidentiality, and will remain anonymous. Clinical trials still require HIPPA compliance.
What are the qualities of a good candidate? Visit Compliancy Study Drug Compliancy Good Communication / Comfortable asking Questions Reliable Transportation Able to Stay in Contact for Duration of the Trial
What to expect as a participant throughout the clinical trial...
What prevents people from participating in clinical trials? 1. Fear of Risk - The eligibility criteria of a trial is designed to ensure safety and reduce risk for all its participants. However, there are still potential risks to participating in a clinical trial. Our study team will educate you on all the potential risks (adverse events such as site injection irritation, GI upset, skin changes/rashes, weight changes) before any decisions are made by you, and are prepared to intervene immediately if ever an adverse reaction occurs. 2. Uncertainty of Treatment (Placebo) - Participating in something with only a chance to receive the benefits is offputting for some people, especially when you won't know whether you've been receiving the benefits until the end of your journey. We reassure our potential participants that even if they are on the placebo arm, they can still benefit from the trial in many ways. Without a placebo arm in a clinical trial, the data would not be viable. Drugs that could potentially help people like yourself and your peers would not have a chance to be approved without a placebo arm. There's also a phenomenon called the placebo effect, where even though you're not receiving the study medication, you could still experience the benefits of the trial. And there's also the possibility that the study medication is approved for your condition after the completion of the trial, and you're then able to be prescribed the medication and benefit from it that way. 3. Uncertainty of Resources Needed to Take Part in a Clinical Trial - Our study team is very thorough when sharing information with potential candidates on any ongoing trial. You will be explained all the necessary assessments/visit schedule/travel requirements/etc before you make any decisions on whether you want to participate in the trial or not. 4. Lack of Knowledge and Understanding of the clinical Process - Our study team will make sure you are fully informed on the processes you may go through in a clinical trial. Feel free to reach out to us directly for further details/explanations. We love educating people on clinical trials! 5. Study Burden/Exhaustion - Some trials can be lengthy, multiple months or years long. Know that our study team has plenty of experience with these lengthy trials and the types of exhaustion seen from our previous and current participants. We will try in every way to keep the trial experience enjoyable and engaging so that all participants can see it all the way through.
Do you offer transportation to the clinical site? Yes, we do! Please let us know prior to your visit so that we can arrange transportation.