You can participate in a clinical trial if you meet very specific criteria. These might include the type of disease, how severe it is, other health conditions, or other factors.

To find out if you qualify for a study, ask your doctor about:

• Inclusion criteria: What factors determine whether you can be included, and
• Exclusion criteria: What factors would prevent you from participating.

Some patients may take part in a clinical trial when there are no approved treatments for their disease, or when they are not candidates for, or no longer respond to, available treatments. 

Participation in a clinical trial may not guarantee a patient receives the investigational treatment. In some clinical trials, a patient might be given another approved drug or, in some cases, a placebo (inactive substance). This helps researchers determine whether the new drug is safe and effective. 

The drug or vaccine is being studied in a clinical trial to determine whether it is effective for different people, among other things. The purpose of a clinical study is to help researchers understand:

• whether it is safe,
• what its side effects are,
• how much is needed to have a therapeutic effect (i.e., benefit), and
• how well it works, compared to a current standard treatment or a placebo (which is an inactive substance).

All clinical trials have possible risks, some of which are known before the study starts. Before you decide to participate, these risks will be explained to you.

If you choose to join a study, your health will be closely monitored. Your care will be adjusted if the medical team thinks it’s in your best interest. 

While side effects may occur with any medical product being studied, the safety and well-being of study participants are top priorities for the sponsors, doctors, nurses, and research professionals who conduct clinical trials. 

If you decide at any time that you wish to end your study participation, you may do so without providing a reason.

Placebo is another name for an inactive substance. A placebo may look like the medicine being studied, but it has no medical effect. Placebos are sometimes used to help researchers tell the difference between the medicine being studied and no treatment. 

During the consent process, you will be told whether the study involves the use of placebo, and what your chances are of receiving it. Typically, you will learn that your chances of receiving a placebo are like the flip of a coin. You will also be informed of any potential risks if you receive a placebo. 

In most cases, the participant will not know whether they have received the investigational drug or vaccine, an existing treatment, or placebo. The medical professionals will often not know, either. This is called a double-blind trial. It helps minimize any bias or prejudiced opinion when researchers compare people who received the investigational drug to those who did not. 

Placebos are very rare in cancer clinical trials. At Sanofi, we strive to minimize the number of patients in this group without compromising the quality of the study. We also try to minimize how long a placebo may be given.

Each study is different, but you may receive either the investigational medication and/or placebo. An investigational medication is what is being studied to see if symptoms improve while taking it. The investigational medication is not yet approved for general use by regulatory authorities. A placebo is an inactive substance or treatment that looks the same and is given in the same way as the investigational treatment that is being studied.

Every clinical trial has a set of criteria that study participants must meet to participate, including agreeing to sign an informed consent form. In a double-blind study, neither the study participant nor the study doctor will know which treatment the patient is receiving. In an open-label study, both the study participant and the study doctor will know the treatment that is assigned.

Guidelines and safety procedures change frequently for medical facilities where clinical trial participation occurs. Your study site will provide you additional information regarding necessary precautions. Additionally, alternatives to onsite participation may be available in your area including:

• Having the investigational study drug sent directly to you at home
• Conducting a telehealth/video conference
• Performing study visits at your home

Participants may need to provide consent prior to participation.

Common examples of biomarkers (short for biological markers) include blood pressure, heart rate, X-ray findings, blood glucose, and gene mutations. They are characteristics of the body that can be measured and evaluated objectively. Biomarkers were first used in clinical studies in the 1960s. They are important to drug discovery because they help measure the effects of an investigational medicine or vaccine. That helps researchers determine whether a therapy is effective at treating a particular disease.

Understanding how a disease works – and how a drug does or does not affect that disease – depends on identifying the right biomarkers to study. Sometimes, researchers discover a new biomarker that tells them something important about a disease. For example, they may discover that people with a particular gene mutation may have a high risk of a certain disease. An example of a digital biomarker might be a change in how a person moves.

Understanding how to interpret biomarkers could help medical professionals and patients better manage a disease. They could potentially help doctors diagnose patients and match them to the best potential medicine more quickly. Ultimately, this could improve health outcomes.

By leveraging mobile technologies, decentralized clinical trials bring the clinical trial to the patient. This can make research more accessible and less burdensome for participants, broaden the scope of people who can participate, and allow researchers to gather more real-world data about the patient experience.

While decentralized clinical trials are gaining momentum, there is still work to be done. Sanofi is part of three major projects that bring people across the industry together to increase the uptake of decentralized clinical trials: The Decentralized Trials Research Alliance, TransCelerate BioPharma, and the Innovative Medicines Initiative.