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Clinical trials (or research studies) are a type of medical research in which people volunteer to take part. Clinical trials commonly study how potential medicines and other medical treatments affect the participants.

All medicines that become available for use in patients are first tested in clinical trials involving hundreds to thousands of people.

Drug development is the journey from an idea for a potential medicine all the way through to bringing that new medicine to patients who need it. The development lifecycle includes laboratory research and a series of clinical trials in people. Along the way, important information is collected about the potential medicine and how it affects clinical trial participants. If that information shows the potential medicine is safe and effective, clinical trial sponsors provide the information to the regulatory authorities who decide whether to approve the medicines or vaccines for use by patients outside of clinical trials.

What happens in a clinical trial depends on the protocol. A protocol is a detailed plan that explains the purpose of the clinical trial and how it will be run. If you consider joining a clinical trial, these details will be explained to you as part of the informed consent process. They include:

• the length of the clinical trial
• the study medicines, procedures, and tests in the clinical trial
• the schedule of study activities
• information about who can participate
• how side effects will be tracked, managed, and reported
• the rules that must be followed

• As part of a clinical trial, a study-related medical care is provided by the study team at the site location. This includes the principal investigator (or study doctor), the healthcare professional who conducts and takes responsibility for the trial at that location, as well as other clinical study team members.
• During a clinical trial participation, you may also continue to see your regular medical doctors for any care that is not related to the study. It is important to tell the study team about other conditions you might have and to let them know which other doctors are caring for you. This helps the study team coordinate your overall care.
• If you participate, the clinical trial will provide study-related medical care, and your regular medical doctors will address the other aspects of your health. Your regular medical doctors can also work with the study team to understand the details of the study and any impact it may have on your regular medical care.

All clinical trials have possible risks. The known and unknown risks of participating in a specific study will be explained during the informed consent process that happens before you decide whether to participate.

Clinical researchers must follow guidelines and regulatory requirements to help protect the rights, safety, and well-being of clinical trial participants. These include Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical trials.

There are also many entities that provide oversight of clinical trials. These include health authorities or regulators, institutional review boards and independent ethics committees, and data safety and monitoring boards.

An Informed Consent Form is a document that explains everything you need to know before deciding to join a clinical trial. It is written to help you make an informed choice, clearly and without pressure.

A typical ICF includes:

1. Purpose of the study: What the study is about and why it’s being done.
2. What will happen if you join: What visits, tests, treatments, or procedures you can expect.
3. Possible risks and side effects: Any known risks, discomforts, or side effects of the treatment.
4. Possible benefits: How the study might help you or others in the future.
5. Voluntary participation: A clear statement that joining is your choice, and you can leave at any time.
6. Privacy and confidentiality: How your personal and medical data will be protected.
7. Contact information: Who to contact if you have questions or experience any problems.

A trained member of the study team, usually a study doctor (investigator), research nurse, or clinical trial coordinator, will guide you through the Informed Consent Form.

Their role is to:

• Explain the study in clear, understandable terms
• Answer all your questions honestly and patiently
• Make sure you fully understand what participation means
• Support your decision, whether you choose to join or not

You’ll never be expected to read or sign the form alone. You’re encouraged to take your time, discuss it with family or your doctor, and only sign if and when you feel fully comfortable.

Even after you sign, you can withdraw at any time, your rights and care won’t be affected.