A clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of a potential new medication. Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about a potential new medication, such as:

• How safe is the potential new medication?

• Does it work?

A potential new (investigational) medication, also sometimes called an investigational drug or a study medication, has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. An investigational medication also may be a medication that is approved for the treatment of one disease or condition but is still under investigation in other diseases or conditions. An investigational medication can only be used in clinical research studies.

All potential new (investigational) medications must be tested in clinical research studies before they can be approved by authorities to be prescribed to patients. Without people taking part in these studies, we would have no new medications.

If you or your loved one pre-qualify, a member of the research team at a nearby study location will contact you. They will explain the study in more detail, answer your questions, and guide you through the next steps. This will most likely include an in-person or virtual visit to check additional criteria in order to confirm your eligibility. The research teams can be very busy so it may take a few days to receive the call or message. If it has been 3 or more days since you pre-qualified, you can call the study center at the phone number in your confirmation email.

Pre-qualifying means you match basic study requirements, but it does not guarantee that you will be able to take part. Pre-qualification is only based on information you provide through the online questionnaire completion. Think of pre-qualifying as the first step to see if a study may be a good fit for you based on factors such as medical conditions, prescription medicine usage, procedure history, and more. If you pre-qualify, you will receive a message with details on the name of the research team that will aim to confirm your full eligibility through additional questions and/or medical assessments. There is a chance that you may not ultimately qualify based on the additional criteria the study team will check.

Each study has specific requirements to help keep participants safe and ensure meaningful results. You might not pre-qualify if your medical history, current medication usage, or other factors including diagnosis timing, pregnancy status, and symptom severity don’t fit with study requirements. If you do not pre-qualify for one study, you could still pre-qualify for others that have different criteria.

When you complete the questionnaire, your ZIP or postal code will be the key factor in trying to match you to a nearby study location. Every study has different locations. Sometimes one study location will close for enrollment while a new one will open. If there is no study location nearby when you complete the questionnaire, you can choose to be contacted if one opens later that is close to where you live or work. If the location offered to you is too far, you can decline.

The study-required potential new (investigational) medication or placebo will be provided at no cost. The person taking part in the study will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.

Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.

Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.

It is a personal decision to take part. Participation in a study is voluntary. Please also consider:

• If a decision is made to participate, you/the person taking part can withdraw at any time during the study.
• The study team will explain the possible benefits and risks of the study during the informed consent process.
• A person does not have to join any study if they don’t want to.
• A team of doctors and nurses will carefully monitor the health of people taking part during the study.
• The potential new (investigational) medication or placebo will be provided at no cost.
• Taking part in the study may help other people with weight- and hormone-related conditions in the future.

ClinicalResearch.com was created by IQVIA, a global leader in clinical research and healthcare technology. Our goal is to make it easier for people to learn about clinical trials and explore opportunities to take part.

IQVIA works with researchers and healthcare partners around the world to support studies that aim to improve medical care. With operations in over 100 countries and a team of approximately 86,000 professionals, we’re committed to making clinical research more accessible and understandable.

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