Sanofi's Clinical Research Areas

Here at Sanofi, we are constantly working to pioneer and facilitate clinical trials across these therapeutic areas. Our team drives innovation and excellence in clinical research, conducting dozens of clinical trials and studies with the support of hundreds of volunteers in the last year alone.

Check the Sanofi Clinical Trials registry to learn all about our current and upcoming clinical trials.  

Prospective participants and patients may be interested in a clinical trial after seeing information online, or may be recommended by their healthcare provider. Those interested in volunteering for a clinical study should always consult their healthcare provider.  

Once a volunteer expresses their interest, they’re asked to carefully read and complete an informed consent form. This form contains all details of the scope of the trial and its impact, and signing of informed consent is essential for participation in a trial.  

This process is different for children, and in the US, all information about the clinical trial is explained to the parent/guardian. The child, where possible, should also express the willingness to participate.¹ 

All information about clinical trials is public and can be found on the Clinical Trials Registry. Sanofi’s clinical trials can also be found on our dedicated Sanofi Clinical Trials Finder. 

All the people who participate in a clinical trial are volunteers. Anyone interested in a clinical trial is absolutely under no obligation to participate. When a participant chooses to stop their involvement in a clinical study, it is known as premature withdrawal, and is feasible at any time depending on their comfort and concerns.  

Not every volunteer who wants to participate in a clinical trial is eligible. Studies often have rigorous criteria for participants, and only volunteers who meet all the relevant criteria can participate. Clinical trial screening is the process used to check if the volunteer is suitable for the study.  

This involves a discussion with a medical staff member, followed by a physical exam and diagnostic tests relevant for the trial. Diagnostic tests for a clinical trial are usually more extensive compared to usual check-ups for the concerned health condition to ensure the volunteer is within the inclusion criteria.  

If the volunteer is found to be qualified, the medical staff will explain potential risks or inconveniences associated with the clinical trial, along with any additional considerations associated with pregnancy and breastfeeding.  

The staff will also explain any potential benefits in case the clinical trial is testing a drug that has an expected clinical benefit for the participant. The volunteer can access the results of their screening tests whether they qualify or not.

Clinical trials are generally divided into three phases: Phase 1, 2, and 3. However, sometimes they may have four to five phases with the addition of Phases 0 and 4.² 

Phase zero clinical trials: also known exploratory IND (investigational new drug) studies, these are early studies with minimal human exposure to study the drug’s mechanism of action. These trials typically involve around 10-15 patients for less than a week.  

• Phase 1 clinical trials: these are designed to test the best possible way to safely administer a drug, including dosage amounts, frequency and the mode of administration (i.e. injections, tablets etc.). Phase 1 trials usually contain 20–100 patients.  

• Phase 2 clinical trials: these are focused on finding the best dose for the medication and characterizing treatment effectiveness. Phase 2 clinical trials contain upwards of 100 participants. 

• Phase 3 clinical trials: these are full-scale trials designed to compare the effectiveness of the candidate treatment against the current standard treatment (Standard of Care/SoC) or a placebo. These trials involve large groups of hundreds to more than a thousand participants.  

• Phase 4 clinical trials: these sometimes occur after the approval of the drug by regulatory bodies like the FDA. The drugs are proven to be safe and effective, and Phase 4 trials are mainly concerned with long-term effectiveness and potential side effects. 

Diversity is an important part of a clinical trial: ensuring that the trial population is representative of the patient population is essential to truly test the treatment’s safety and effectiveness. We recognize this and are constantly evolving our protocols to champion diversity, including engaging with new trial sites and physicians.  

Learn about Sanofi’s commitment to diversity in our clinical trials. Sanofi also offers Post-Trial Access (PTA) for certain drugs to a clinical trial participant after the trial if the treatment benefits them under certain conditions.