A clinical study is a form of research that involves human volunteers, known as participants (healthy or affected by a disease). These studies explore new treatments or interventions to expand our medical knowledge and find new healthcare solutions.
Clinical studies study diseases, diagnostic tools and interventions or treatments such as new drugs, vaccines, medical devices, medical procedures, and behavioral programs including educational, diet, or exercise plans.
Volunteers who meet specific study requirements like age, health condition, or treatment history are eligible to join a clinical study. Someone from the study team will screen all volunteers to see if they meet these requirements.
No, a participant is welcome to directly contact the staff of any ongoing study.
If a patient doesn’t qualify for a study, they should consult with their healthcare provider to explore other available treatment options, and this result will not impact their level of care.
Participating in a clinical study is both a personal journey and a meaningful way to help others who have a similar condition. Joining a clinical study can offer access to specialized care and more frequent contact with Healthcare Professionals. Whether someone is a healthy volunteer or living with a specific condition, patient involvement drives medical progress.
Yes, participating in a clinical study does come with some risks. There is no guarantee that the treatment being studied will improve a participants’ condition. It’s possible that a participant may see no benefit or that their symptoms could remain unchanged or even worsen. Treatment could also come with side effects.
However, the study is designed with precautions in mind to maximize safety. To conduct a study, researchers secure approvals from the Regulatory Authority and a Research Ethics Committee or Institutional Review Board. These groups make sure that the study is conducted ethically, with respect to participants’ rights and safety. Participants have the freedom to withdraw from the study at any time if they so choose and there will be no impact on regular care they’ll receive.
Every study has its own timeline, shaped by several factors, including the phase of the study, its design, treatment duration, and the specific health condition being studied.
During the consent process, before a participant enrolls, the study team will explain the key details of the study. This includes the number of visits they'll need to make to the clinic or hospital, the approximate length of each visit, and the types of examinations or procedures they will undergo.
Study sites vary and may include hospitals, medical centers, universities, or doctors’ offices. Some studies operate across multiple locations, and each site is equipped with a dedicated study team. In some cases, certain study activities might be carried out in the comfort of a patient’s own home.
Every clinical study follows a specific protocol. This is like a project plan that describes how the intervention will be studied, including how participants are divided into groups, the number of required clinic or hospital visits, the exams performed, and the health outcomes being measured.
For instance, participants may be randomly assigned to receive the experimental treatment, the current standard treatment, or a placebo (that is no treatment at all). The intervention's safety and effectiveness are then assessed by comparing results from each group.
Children can participate in studies specifically designed for them, which adhere to strict regulations and ethical standards to ensure their safety. Because children’s bodies are still developing, they may respond differently to treatments than adults. Studying these differences is crucial to tailor interventions effectively. Additionally, many conditions only affect children, which is why it’s important to understand the best treatments for them.
Not all studies pay participants, but most provide compensation for travel, time, and participation, depending on applicable regulations. Compensation details vary by study type and local regulations. Generally, participants do not have extra out-of-pocket costs for interventions in a clinical study. Participants will learn more about their options during their initial discussion with the study team.
Coverage in clinical studies can vary due to different regulations across countries. Participants in the trial will learn more about their options during the initial discussion with the study staff.