What is a clinical trial?
Clinical Trials can also be referred to as Clinical Research Studies or Clinical Studies.
Before a new treatment can be made available to all potential patients, it must be deemed effective and well tolerated. A clinical trial, or study in humans, is a mandatory part of the process leading to the approval of a potential treatment by health authorities. The treatment, or "investigational product", might be a new vaccine, drug, or combination of drugs, or it could be a new way to use an existing compound. A clinical trial is designed to either:
- validate the new drug or vaccine, or
- define the patient populations in which a potential treatment would be most effective.
In the study, the effect of the investigational product is compared to either a placebo (a substance with no pharmacological activity) or an existing treatment to determine whether it is safe and effective. Over the course of a full clinical trial, researchers aim to determine:
- the effective dose regimen,
- its possible toxicity, and
- the nature and frequency of any adverse events it may cause.
Sanofi clinical trials are designed with input from representatives of patient communities, physicians, and staff where the studies are conducted. This helps ensure the studies are aligned with the relevant needs of patients and healthcare professionals, as well as regulators around the world.
How do clinical trials work?
Clinical trials must adhere to Good Clinical Practices (GCP), rigid standards that clearly state what is allowed by medical professionals during a clinical trial.
Clinical trials follow rigid testing procedures designed to help researchers determine the safety and effectiveness of the investigational drug or medical treatment being studied.
What is an investigational medication?
An investigational medication is what is being studied to see if your disease or symptoms or medical condition improves while taking it. The drug is not yet approved for general use by regulatory authorities.
Why should I join a clinical research study?
Thousands of people volunteer to participate in clinical trials every year. The reasons for participation vary, but all of them help to advance medicine. Some reasons include:
- Medical supervision. Some people have a disease for which there is no approved treatment. They might join a clinical trial in the hopes of receiving an investigational medicine.
- Contribute to future treatments. Many participants wish to help future patients. This has been reported by both patients and healthy volunteers.
- Help improve the lives of others. Some people participate with the hope of helping others. The investigational medication may benefit other patients and, in some cases, save lives.
Who can participate in a study?
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.
What is an informed consent?
Before you decide to participate in a clinical trial, you will go through a process called "informed consent". This is designed to help you learn the facts about the clinical trial before deciding whether to participate.
You will be given detailed information about the study. This includes:
- the purpose,
- the possible risks,
- the potential benefits,
- how long it will take,
- what procedures are required, and
- whom to contact with any questions or issues.
Once you understand this information, you may decide to participate. At that point, you will be asked to give your consent. You will need to sign an “informed consent” document to confirm your decision.
Then, you will go through a screening process to find out if you qualify to participate in the trial, based on the inclusion and exclusion criteria.
What is an open label study?
Both the study participant and study doctor will know the treatment assignment.
What is a Phase III (Phase 3) trial?
Larger groups of patients (typically several hundred to thousands of people) participate in Phase 3 clinical trials. These studies can take many years to complete. They are often carried out in many different locations.
The purpose of a Phase 3 trial is to determine:
- whether the investigational drug or vaccine is safe, and
- whether it has a therapeutic (beneficial) effect.
In this type of study, researchers compare the investigational treatment with the current standard treatment or placebo. They monitor any side effects very closely.
In most cases, a 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, and helps researchers draw conclusions with confidence.
What type of study-related medical care is provided during a study?
All study-related medical care related to the study is provided, including study-related exams, study-related medications and other study-related medical care. There is no insurance required to participate. All study-related medical care will be explained.
Studies may also offer compensation in return for travel.
Is it safe to participate in a clinical trial?
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 point–that you wish to end your study participation, you may do so without providing a reason.
What about clinical trials participation during COVID-19?
This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19. Each individual site location will review their protocols including mask wearing, social distance, pre-appointment check in. Study sites are medical facilities where COVID safety procedures are followed.
The COVID-19 vaccine can be administered before entering in the study or afterwards, without needing study drug interruption. This should be discussed with your study doctor.
Can I speak with someone if I have questions?
Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will contact with you. You can ask questions at any time, before deciding to participate and during study conduct.
I speak Spanish, not English. Can I participate in the study?
Yes, if you let the doctor know, the study site can provide you with translated materials and may be able to provide an interpreter.