Every clinical trial is a journey toward better treatment options.
See inside the clinical trial experience.
Clinical Trial Design
Clinical trials are designed to test how medicines work in people. For each clinical trial, researchers ask a specific research question, often about how medicines affect people with certain conditions such as cancer. The research team then designs the setup of the trial, including who can participate, how many participants are needed, the schedule of tests, procedures, and medicines, and how to analyze the trial data.
The goal of clinical trial design is to find a clear answer to the research question. Overall, clinical trial design is an important factor in helping researchers know whether a medicine is safe and effective. Through clinical trials, researchers gather data of a new medicine’s safety and effectiveness, which the U.S. FDA (U.S. Food and Drug Administration) needs to approve the medicine.
Clinical Trial Phases
Clinical trials are divided into four phases that build on one another. As trials move through these phases, we improve our understanding of new medicines and help guide them toward the approval stage. The information described below pertains mainly to oncology clinical trial design.
Phase 1
Test the Safety
of a Medicine
Phase 1
Phase 1 trials test the safety of a medicine in small groups of participants. During this phase, researchers determine which dosage of the medicine is safest while causing minimal side effects.
Typical length of a Phase 1 trial: several months. Phase 1 trials can have anywhere from several subjects to 100.
Phase 2
Find Out If a
Medicine Treats Disease
Phase 2
In Phase 2, trials engage larger groups of patients who receive the dose of medicine determined in Phase 1. Phase 2 trials test whether the medicine works to treat a disease such as cancer. Benefits that the research team look for may include the cancer shrinking, disappearing, staying at its current size, or taking longer to come back.
Typical length of a Phase 2 trial: several months to two years. Phase 2 trials can have up to several hundred participants.
Phase 3
Compare a Medicine
to the Standard of Care or Placebo.
Phase 3
Phase 3 trials test whether the medicine is better than the current standard of care and typically involve large groups of participants. Usually, participants are chosen at random to receive either the new medicine or the control, which can be a placebo and/or standard of care. As with the other phases, patients in Phase 3 trials are carefully monitored for any side effects. If the treatment shows significantly better results than the control, the drug may be submitted to the FDA (U.S. Food and Drug Administration) for review and possible approval.
Typical length of a Phase 3 trial: one to four years. Phase 3 trials can have anywhere from 300 to 3,000 participants.
Phase 4
Study a Medicine's
Long-Term Benefits and Risks
Phase 4
Phase 4 trials are carried out after the medicine has been approved by the FDA (U.S. Food and Drug Administration). These trials study the medicine’s safety over time and may involve thousands of people to determine the long-term benefits and side effects.
Typical length of a Phase 4 clinical trial: several years.
Common Questions about Clinical Trials
Clinical Trial Safety & Privacy
There are many measures in place to protect your safety during a clinical trial:
- Clinical trials must be carefully reviewed and approved by doctors and scientists before enrolling participants.
- Numerous committees and government agencies, including the FDA (Food and Drug Administration), OHRP (Office for Human Research Protection), and IRBs (Institutional Review Boards), closely supervise clinical trials to protect participants' safety.
- The informed consent process outlines the benefits and risks as well as participants’ rights. The research team explains the details of the clinical trial, including its purpose, length, and the types of procedures and tests it involves. They answer any questions you may have. You also receive an informed consent document with these details and an explanation of the trial's potential benefits and risks. Once you have reviewed this information, you can decide whether you want to participate.
- Frequent visits and follow-ups with the medical/research teams so they can evaluate how you are doing with the treatment.
Clinical trials allow researchers to learn about the safety and effectiveness of the new medicine. When participating in a clinical trial, you may experience side effects ranging from mild to serious. The new medicine may not work or may not be any better than the current standard of care.
Clinical trial records are private, confidential, and protected by HIPAA (Health Insurance Portability and Accountability Act), though some people may need to look at them, such as experts who monitor trial safety. Published findings from the trial will not include your name or any identifying information.
How do I decide if I want to participate in a clinical trial?
Before deciding to join a trial, you should consider the following:
Potential Benefits of
Joining a Clinical Trial
- You may help advance medicine by improving the understanding of how new medicines work in people.
- You may gain access to new medicines when they’re only available through clinical trials.
- You will take a more active role in your own healthcare.
Questions About
Joining a Clinical Trial
- The clinical trial may require more visits and testing than the standard of care for your condition.
- In some trials you may receive a placebo, which is an inactive medicine that helps the research team better understand the active medicine they are testing.
- You may experience side effects or the new medicine being tested may not work for you.
Diversity in Clinical Trials
Clinical trials move medicine forward and contribute to better options for everyone. Because we all have different backgrounds, we may experience a disease or condition differently and respond to medicines differently. That’s why diversity in clinical trials is so important.
Clinical trials that include people of different genders, ethnicities, ages, sexual orientations, communities, and experiences will give us the most complete information. When we increase diversity in clinical trials, we produce data that shows how new medicines work for all kinds of patients. This allows everyone to benefit from medical advances.
Clinical Trials Step By Step
Prescreening
In this first step, you will be asked questions about your health and medical history. This information will help the research team decide if you are eligible to participate in the trial.
Informed Consent
Once the research team has confirmed that you are eligible to participate, they will explain the trial in detail, answer any questions you have, and give you an informed consent document. This document outlines the trial and its potential benefits and risks. You will review all the information and decide whether you want to participate in the trial. You are free to leave the trial at any time.
Screening
If you decide to participate in the trial, you will meet with the study doctor and study team for a review of your medical history and often a physical exam. Lab work (such as blood tests and urine tests) and other tests (such as x-rays) may be performed as well.
During the Trial
The trial may take place in a hospital, university, doctor’s office, or other location. As a participant, you will attend appointments and follow directions from the research team. Doctors and nurses will carefully monitor your health during the clinical trial. They will record and treat/manage any problems or side effects and make every effort to keep you safe.
After the Trial
Researchers often study trial data and continue to learn about a new medicine for many years. If the data show that the medicine is safe and effective, the team can apply for approval from the FDA to make the medicine available for use in patients.
Want to learn more about the clinical trials Servier is conducting?
Explore Servier’s clinical trials. ⟶References
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- Learn About Studies. National Library of Medicine. https://clinicaltrials.gov/study-basics/learn-about-studies. Accessed January 19, 2024.
- Types and Phases of Clinical Trials. American Cancer Society. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html. Accessed January 19, 2024.
- The Basics. National Institutes of Health. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics. Accessed January 19, 2024.
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- Basics About Clinical Trials. U.S. Food & Drug Administration. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials. Accessed January 19, 2024.
- Are Clinical Trials Safe? National Cancer Institute. https://www.cancer.gov/research/participate/clinical-trials/safety. Accessed January 19, 2024.
- Diversity and Inclusion in Clinical Trials. National Institutes of Health. https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html. Accessed January 19, 2024.
- Being in a Clinical Trial. American Cancer Society. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/what-you-need-to-know/what-does-a-clinical-trial-involve.html. Accessed January 19, 2024.
- Screening Tests Prior to Study Enrollment. U.S. Food & Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/screening-tests-prior-study-enrollment. Accessed January 19, 2024.
*Disclaimer: This website is for informational and educational purposes only and is not a substitute for professional medical advice, diagnosis and treatment.