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What are clinical studies?
Learn more about clinical research below.
Clinical studies, such as those within the ODYSSEY clinical trial program, can help to increase medical knowledge and understanding of a disease or condition. Without clinical research and the involvement of participants like you, there would not have been the advances in treatments you see today. By taking part in a clinical study, you may get the chance to try an investigational medication which could help to increase future treatment options.
Unfortunately, not all study treatments help all those who take part; nor are they all approved. Despite this, pharmaceutical companies like Sanofi US Services Inc and Regeneron Pharmaceuticals, Inc are committed to continuing to develop new and effective treatments which will positively impact lives.
Why are clinical studies so important?
Before any new medicine is approved and made available to patients, it must go through several stages (called phases) of clinical research to prove they are safe and effective (i.e. Does this treatment work better than others? Does it have any side effects? Which patients does it work best in?). Without clinical studies it would be impossible to know.
Getting the facts and giving informed consent
Before you agree to take part in any clinical study, the regulations require that you are given full and clear information about the clinical study and all that it involves. This information is provided in a Patient Information Sheet, which must include the following details:
The study team running the trial will talk you through all of this information and if there is anything you do not fully understand they will take the time to explain it to you. The study team will make sure you have time to take in important information, and to discuss it with them and others. If you are at all unsure about something, the study team is there to help you.
By signing the Informed Consent Form, you confirm that you have been given and understand the Patient Information Sheet and that you agree to take part in the study. However, you can change your mind and leave at any time (you may be asked to visit your study site team for a final set of tests before you stop). You are also free to discuss the trial and any concerns that you might have with your own doctor at any time.
What happens during a clinical study?
Once you have signed the Informed Consent Form, your participation in the clinical study will begin. Your study doctor will explain how the study will work based on the study protocol which has been designed and approved by doctors and researchers. Appropriate steps have been taken to ensure the protection of people who take part in clinical studies and all protocols for clinical trials are approved to ensure they are scientific and ethical. The protocol includes details about:
Each study has a different schedule which sets out how many study visits are involved and over what period of time. It also details what needs to happen at each visit, as well as what happens between visits. You will be asked to take the study drug, as outlined in the study protocol, to have certain tests and physical check-ups, and to inform your study doctor of any negative symptoms or adverse effects you notice from the study drug. You may also be required to keep records of any effects and/or your daily activities. The study site team will explain what’s involved when you meet them, but you should also feel free to ask any questions that you have – before and during the trial.
How are people selected to take part in studies?
Each clinical study has its own set of rules on who can and cannot take part. These are called ‘inclusion and exclusion criteria’ or ‘eligibility criteria’. The inclusion criteria ensure that enough people at a similar stage of disease are involved in a study. This helps to find out which patients the investigational treatment may be most suitable for. For example, the LTS11717 study protocol states that only individuals who are over 18 years old, with high cholesterol (higher than or equal to 100mg/dL or ≥2.59mmol/L), at high cardiovascular risk and who are taking cholesterol lowering treatment may participate. Every study is different.
Exclusion criteria are in place to protect trial participants. For example, you may not be able to take part in a trial if you are taking an existing medicine that could interact with the investigational medicine. Pregnant women are often excluded from clinical trials. If your doctor or the study doctor thinks that you may be eligible, they will review the eligibility criteria and decide whether you are suitable for the trial in question. He/she will then discuss your options and whether or not you would like to take part.
Should I get involved?
The ODYSSEY clinical trial program may be an opportunity for you to gain access to an investigational treatment that is being assessed to see if it is safe and effective in reducing your LDL cholesterol levels.