Clinical trials at a glance
At a glance
Our biotech mindset, combined with the scale and advantages of a global pharmaceutical company, has established us as a development powerhouse in our core areas of focus. A global network of healthcare professionals help us test new treatments and ensure their efficacy and safety by conducting studies called clinical trials.
We have therapeutically-aligned teams, global expertise in regulatory affairs, patient safety and medical affairs, as well as a proven ability to bring new, life changing therapies successfully through clinical development.
At a glance
What is a clinical trial
What is a clinical trial
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.
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?
Both interventional and observational studies are important for increasing our understanding of diseases and their treatment.
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.
Phases of clinical trials
Researchers conduct clinical trials in a series of steps, or phases, from I through IV.
In phase 1, 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 2, a larger group of patients receive the treatment to test both safety and effectiveness.
In phase 3, even more patients receive the treatment to confirm its effectiveness and safety and to compare it with other possible treatments.
Phase 4 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.
Early Access Public Policy
Ipsen’s vision is to be a leading global biopharmaceutical company focused on innovation and Specialty Care and our mission is to improve patients’ lives through innovative new medicines
Ipsen commits to enable Early Access to patients to Ipsen Products which are not yet approved by local Health Authorities, hence not yet available for prescription, when the Ipsen Product is considered as eligible for Early Access.
What is “Early Access”:
Ipsen defines “Early Access”1 as access to:
- Unapproved medicine for the requested indication in the country where the request comes from
- For life-threatening or serious medical conditions
- Where there is no satisfactory alternative therapy available for the given medical condition
- Where there is no alternative option for the patient to participate in an ongoing clinical trial in the given indication
- Where the medicine has reasonable medical evidence of the positive balance of benefits/risks in the given indication and the medicinal product has started the regulatory process of approval in the US and/or the EU
Early Access can only take place if it is allowed within the local laws, rules and regulations or specifically approved in writing by local authorities.
The physician and the patient should discuss the expected benefits, known and potential unknown risks before seeking Early Access to a medicinal product.
In some cases, Ipsen may set up a program designed to provide Early Access to several patients in defined countries.
The list of Ipsen’s Early Access Programs in the United States is available on www.clinicaltrials.gov.
Request for Early Access to an Ipsen Product:
Who can request Early Access?
Only qualified Physicians can make requests for Early Access to an Ipsen Product once they have exhausted all other appropriate and available options to treat the medical condition of their patient, including enrollment in a clinical trial.
How can the Physician contact Ipsen and make a request?
Physicians can contact Ipsen and send a request for Early Access to: GlobalMedInfo@ipsen.com
What will happen to the request?
When the request is received by Ipsen, Ipsen will send an acknowledgement of receipt of the request within 48 business hours. The request will be assessed by Ipsen medical affairs fairly, as promptly as possible and after a thorough discussion with the Physician as necessary.
The decision will be based on at least the following criteria:
- The conditions for Early Access are met
- Patient’s individual medical conditions
- Ipsen product availability
- Regulatory and health system environment where the request has come from (e.g. to make sure a Pharmacovigilance structure is in place)
What will happen if the request is approved?
If the request for Early Access is approved by Ipsen, the Physician must collect and complete all necessary documents to comply with appropriate rules and regulations – as quickly as possible. Once collected, Ipsen will send the Physician the requested Ipsen Product for Early Access to treat their patient.
The physician must commit to the regulatory obligations including reporting of adverse events during the entirety of the Early Access.
What will happen if the request is not approved?
Ipsen is committed to Early Access but the company cannot guarantee approval and regrets that there are occasions where it is not appropriate for the company to provide Early Access to its medicine or where the request does not fall within the definition of Early Access. In these circumstances we commit to provide a timely response and clear rationale for the decision.
1. Other terms commonly used: Compassionate Use, Early Access, Expanded Access Program, Managed Access Program, Patient Access Program, Special Access Program, Scheme Access Program, Temporary Use Authorization and Pre-approval access.