• What is a clinical trial?
• Our clinical trials

A clinical trial is a carefully planned study with human volunteers to find out if a treatment is safe and effective. This kind of scientific study is key to all medical advances because it helps answer these questions:

• Does the treatment work?
• Does it work better than other treatments for the same condition?
• Is it safe for different groups of patients?

Each clinical trial focuses on finding a better way to understand, prevent, diagnose, or treat a disease. All clinical trials are scrutinized by outside experts to make sure the health of the participants is safeguarded. In addition, different phases of trials must be carried out to track safety and efficacy before a new treatment is approved and made widely available.

 

WHAT ARE THE BENEFITS OF PARTICIPATING IN A CLINICAL TRIAL?

• Better knowledge and awareness: By participating in the tests and treatments outlined in a clinical trial, participants may gain a better understanding of different measurements and what they mean for health in the short-term and long-term.

• Increased time with medical experts: A clinical trial gives participants the opportunity for more interactions with the medical professionals on the research team, allowing them to learn more while actively tracking and discussing their health.

• Advance access to cutting-edge treatments: Since all new treatments must go through several phases of clinical trials before they become widely available, participating in a trial can be a unique chance to access innovative treatments. As researchers measure participants’ health through the trial, they might even discover unexpected benefits of a new treatment.

• Helping others with the disease: Clinical trial volunteers allow doctors to understand more about how people with the disease are the same or different, so they can improve care for other people with the same disease—which could someday include the volunteer’s friends or loved ones.

• Leaving a mark on medicine: Information from clinical trials is used in scientific publications that serve as permanent records of medical advancement. When clinical trial participants provide information, they are contributing to the pool of data that moves science forward.

 

WHAT ARE THE DIFFERENT KINDS OF CLINICAL TRIALS?

• Interventional vs Observational trials:
  Interventional trials assign a specific therapy or treatment to each participant, so they are an important part of figuring out what health effects are specifically caused by the treatment. Observational trials, on the other hand, track health in more natural settings by studying what people already do; these trials give scientists a more realistic idea of how a certain factor influences health (normally a drug or other medical intervention), but they cannot help determine causal relationships. Both interventional and observational studies are important for increasing our understanding of diseases and their treatment.

• Phases of clinical trials:
  Researchers conduct clinical trials in a series of steps, or phases, from I through IV. If a drug is successful in one phase, researchers may invest in the next phase. In phase I, researchers are primarily concerned with safety, so they test a new treatment in a small group of people—usually in a healthy population. In Phase II, a larger group of patients receive the treatment to test both safety and effectiveness, while in phase III even more patients receive the treatment to confirm its effectiveness and safety and to compare it with other possible treatments. Phase IV trials occur after the treatment is released to the public, in order to track effects of long-term use and commonly reported side effects.

 

WHAT’S THE BEST WAY TO FIND A CLINICAL TRIAL?

Companies that develop new drugs commit to sharing the results of their studies so doctors and patients around the world can benefit from the information. When sharing these details, they must protect participants’ privacy while following the regulatory guidelines of their country. The ClinicalTrials.gov website was developed as a place to post details about clinical studies taking place all around the world. Trials that investigate Ipsen therapies are listed in the ClinicalTrials.gov database, showing that Ipsen is committed to the information sharing that is critical for advancing medicine.

Patients who want to volunteer for a clinical trial can search ClinicalTrials.gov to find suitable studies in their geographic area. After finding a study on the website that looks like a good fit, the patient can contact the study investigators directly for more information on how to take part.