EXPLORE, ENGAGE, EMPOWER

FAQ & EMPOWERMENT

Discover a wealth of educational resources designed to empower patients, caregivers, and curious minds alike.

WHAT IS A CLINICAL TRIAL?

A clinical trial is a carefully designed research study that investigates the effectiveness and safety of new medications, treatments, or interventions in humans.

These trials are meticulously designed and highly regulated experiments, monitored by governmental bodies such as the Food and Drug Administration (FDA) and the Institutional Review Board (IRB), which is composed of both scientists and community activists with non-scientific concerns.

These new interventions can range from potential new drugs and therapies to a new use of existing medication, surgery techniques or radiation therapy. Clinical trials are structured into phases, from Phase I to Phase IV, each designed to answer specific questions while prioritizing patient safety.

CURIOUS OF THE RESEARCH JOURNEY?

Your information is secure and private under HIPAA. We will never share your information with anyone without your explicit consent.

Keep Me Posted on New and Upcoming Studies
  • Experience elevated healthcare.
  • Study care at no cost.
  • No insurance required.
  • Compensation for your time & travel.

WHY IS CLINICAL RESEARCH IMPORTANT?

From the skincare in our cabinets to breakthrough therapies that combat serious conditions, benefits of medical research are felt by individuals and communities worldwide. It is through medical research that we have made significant strides in understanding diseases, developing life-saving medications, and enhancing healthcare practices. By supporting and participating in clinical research, we collectively pave the way for better health outcomes, improved treatments, and a brighter future for all.

BENEFITS OF PARTICIPATING IN RESEARCH

Access to New Treatments

Participants may have access to new treatments that are not yet available to the general public. This could potentially be beneficial, especially for patients who have not responded to standard treatments.

Personalized Healthcare

Clinical trial participants often receive close medical attention from an assigned team of dedicated healthcare professionals. This comprehensive care and monitoring can lead to excellent medical oversight and could help in managing the patient’s condition.

Contribute to Medical Knowledge

Participation in clinical trials contributes to scientific progress and could potentially benefit many people in the future. By participating, patients can play an active role in their own healthcare and contribute to our understanding and management of various medical conditions.

Financial Compensation

Many clinical trials provide financial compensation to acknowledge your time and commitment. However, it’s important to understand that the main goal should be potential health benefits and contributing to medical knowledge, not the financial aspect.

Careful Ethical and Legal Supervision

Clinical trials are conducted following strict ethical guidelines and are overseen by ethical and regulatory bodies to ensure patient safety and data accuracy. This means that patient rights, safety, and well-being are a top priority during trials.

It’s important to remember that every clinical trial is different and potential benefits can vary depending on the specifics of the study. Participation is always voluntary, and patients have the right to leave a trial at any time for any reason.

FAQs

WHAT ARE PHASES IN CLINICAL TRIALS?

Before any medicine lands inside your medicine cabinet, it undergoes a rigorous testing process known as clinical trials. These trials are divided into phases, each with a specific goal and a regulatory review to ensure safety and efficacy. Let’s take a peek at what happens at each stage:

Phase I: Safety First
Phase 1 is all about safety. In this initial step, a few healthy volunteers help us learn how the body responds to a new treatment. It’s like the first test of a drug, focusing on tolerance, the correct dosage, and possible side effects. You’ll hear the term “pharmacokinetics,” which is about the drug’s path through the body, from intake to exit. The main goal is to check and double check safety before proceeding.

Phase II: Does It Work?
In Phase 2, we focus on effectiveness: “Does the treatment work for its intended condition?” We test it on a bigger group with the condition, assessing how well it provides the intended benefit. This phase is key to determining not just if, but how well the drug works.

Phase III: Is It Better Than What’s Available?
Phase 3 III trials compare the new treatment with existing standard treatments. This phase involves a larger number of participants across multiple locations. By comparing outcomes, researchers determine if the new treatment is more effective, safer, or has fewer side effects than current standards of treatment.

Phase IV: Post-Market Surveillance:
Once a treatment is approved and available to the public, Phase 4 IV trials continue to monitor its safety and effectiveness in real-world settings. This phase provides ongoing reassurance about the treatment’s benefits and risks.

Embarking on a clinical trial journey is a big decision, but remember, you’re in good hands. Your healthcare team is dedicated to guiding you, ensuring your experience is safe and comfortable. Each phase of the trial is designed with your well-being as the top priority. Don’t hesitate to ask questions or share concerns… and remember, your participation is both invaluable and always voluntary.

HOW IS MY SAFETY PROTECTED?

The protection of participants in clinical research studies is of utmost importance and is governed by ethical guidelines and legal regulations. Here are several key ways in which participants are protected:

Informed Consent
Before joining a study, participants must be provided with all the information about the trial, including its purpose, duration, required procedures, potential benefits and risks, and alternatives. Participants have the right to ask questions to understand the trial fully before deciding to participate. They must voluntarily agree to participate – this process is called “informed consent”.

Ethics Committees/Institutional Review Boards (IRBs)
Every clinical trial protocol must be approved by an Ethics Committee or an Institutional Review Board (IRB), which is an independent group of professionals designated to review and approve the conduct of research involving humans. The primary purpose of these committees is to protect the rights and welfare of the research participants.

Data Safety Monitoring Boards (DSMBs)
For many trials, especially those that involve serious outcomes, a DSMB oversees the trial and reviews results to identify any safety concerns or significant benefits early.

Privacy and Confidentiality
Participants’ privacy must be maintained and personal health information kept confidential as per applicable laws and regulations.

Voluntary Participation
Participation in a clinical trial is entirely voluntary. Participants have the right to leave the study at any time, for any reason.

Regular Monitoring
Participants are closely monitored during the trial by the healthcare team. Any side effects or adverse events are carefully tracked and addressed.

Reporting Mechanisms
There are systems in place to report and handle any concerns or issues that may arise during the trial.

WHERE DO I START?

Volunteering is simple. Three Easy Steps!

Step 1:
Complete our online form or give us a call at (504)400-0439… we’ll set up a friendly chat with the doctor or study recruiter. They’ll walk you through the study details to paint a picture of what lies ahead. If you meet the study’s criteria and you’re keen to continue this adventure, we’ll gear up for your first mission – the screening visit!

Step 2:
Screening Visit – Once you’ve been confirmed as an eligible candidate, you will be invited to our clinic to review the ICF, a study specific study guide created just for volunteers. Should you decide to move forward, the coordinator may proceed with screening procedures that may include but are not limited to: obtaining blood and urine samples, checking your vital signs, exploring your medical history, and reviewing your medications.

Clinical studies are as unique as the stars in the sky, so the specific procedures during this visit may differ, but will ALWAYS be provided free of charge to both you or your insurance.

Step 3
Study Visits – Once your screening visit is complete and you’ve been confirmed eligible, you’re ready to launch into the main part of your clinical trial journey! Now, it’s time for regular treatment visits. During these visits, you’ll receive the study treatment as outlined in the research plan.

Consider these like check-ins with your dedicated healthcare team. We’ll closely monitor your progress, see how you’re responding to the treatment, and make note of any changes. It is very important to keep the study team current with all of your health information as it ensures your safety during the clinical trial. It’s your chance to share your experiences, concerns, or questions – we’re here to listen!

WHO CAN PARTICIPATE?

Clinical trials are open to individuals of ALL ages and backgrounds, including both healthy participants and those with medical conditions.

Researchers establish specific criteria, such as age, health status, medical condition, and treatment history, to ensure an objective and optimal evaluation of the new treatment. Research studies have specific criteria, known as inclusion/exclusion criteria, to determine who can or cannot participate.

WHAT ARE MY RIGHTS AS A PATIENT?

Informed Consent: Patients have the right to receive clear, comprehensive, and understandable information about the study, including its purpose, procedures, potential risks and benefits, and their rights as participants. They have the right to ask questions and provide informed consent voluntarily before entering the study.

Confidentiality and Privacy: Patients’ personal information, medical data, and identity should be kept confidential and handled securely. Researchers must adhere to strict privacy protocols and regulations to protect participants’ privacy rights.

Safety and Well-being: Participants have the right to receive appropriate medical care and attention throughout the study. Their safety and well-being should be monitored closely, and steps should be taken to minimize risks and ensure participant welfare.

Right to Withdraw: Patients have the right to withdraw from the study at any time, without penalty or impact on their regular medical care. They should be informed of their right to withdraw and understand any potential consequences or implications.

Access to Information: Participants have the right to receive updated information about the progress of the study, any significant findings, and the final results, if available and relevant to their participation.

Ethical Treatment: Patients should be treated with respect, dignity, and fairness throughout their participation in the study. Researchers should adhere to ethical principles, regulations, and guidelines governing the conduct of clinical trials.

Transparent Communication: Clear and open communication should be maintained between researchers and participants. Participants should receive prompt and accurate responses to their questions, concerns, or requests for information.

WHERE CAN I GET MORE INFORMATION?

If you have any questions not answered here, our team will be happy to speak with you. Please do not hesitate to call/text (504) 400-0439 or simply filling out our contact form at the top of the page.

A WIN FOR YOU AND A WIN FOR YOUR COMMUNITY.

Remember, the choice is yours, and there’s never any pressure to commit. We’re here as your trusted guide, dedicated to empowering you to make the best decision for your future.