Clinical trials are at the heart of our mission to develop groundbreaking medicines that improve lives. Read more about our approach here
Clinical trials are a critical part of our journey to evaluate investigational treatments and seek approval from health authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
At Galapagos, we organize clinical trials in various therapeutic areas, conducting research that paves the way for innovative solutions.
Visit our Clinical Trials portal to explore more about clinical trials.
Clear health communications
Health information can be very complex. Explaining to patients a disease or how to take a drug or a drug’s potential side effects can be difficult and can prevent patients from making informed decisions about managing their condition.
Read more on Health Literacy and what Galapagos is doing to reduce the health literacy gap.
Health Literacy means having the knowledge, personal skills, and confidence to take decisions about personal health. As it plays an important role in how patients can understand and act on health information, helping patients understand their health and treatments is critical.
Galapagos has made an important step forward in developing clear health communications and patient-facing documents in clinical trials.
Hear from Manuela, one of our Galapagos patient advocacy leaders, as she explains what Health Literacy is, and why it matters so much to us.
Heidi Muller
Head of Patient Advocacy
We want to improve health literacy, as if we help patients better understand health information, they will be better equipped to take health-related decisions and may change their behavior, like adopting a healthier lifestyle. Or, health literacy can help patients making a confident decision about participating to a clinical trial.
Informed Consent
Information for trial participants is crucial as it respects autonomy, protects individuals from harm, fulfills ethical and legal obligations, fosters trust and transparency, and ensures regulatory compliance.
Given the nature of clinical research – and despite the strong safeguards and regulations that are in place – participants may expose themselves to potential risks. Joining a clinical trial can be a demanding experience and requires courage to help bring a potentially much-needed medicine to the market.
Read more on our efforts below.
As part of the requirements for conducting a clinical trial, Galapagos has to provide potential participants with a document called the informed consent form. It contains everything from the details of a study to the associated risks and potential benefits. This document can be quite complex as it contains scientific, medical and legal language, which is not always well understood by everyone. One also has to keep in mind that the circumstances surrounding an individual’s decision to participate in a clinical trial can bring additional strain and worry for the potential participants.
This may lead them to miss out on some important information or simply not understand all the details provided in the informed consent form. In some cases, this could mean that a person would participate in a trial without fully understanding what is expected, or, conversely, that someone decides not participate because something was misunderstood.
To help potential participants take a well-informed decision, we have been working on improving the Galapagos informed consent form. Together with patients and writers, clinical trial managers, doctors, site and patient engagement leaders, quality monitors, regulatory advisors, scientists, legal and data privacy officers, we have reviewed, revised and redesigned the template informed consent form for participants in clinical trials, with the goal to increase readability and clarity and to remove duplication.
We reduced the content with 40%, while remaining compliant with regulations
We explained complex scientific, medical and legal terms in lay language
We looked at the form from the participant’s perspective and came up with a more logical information flow
We used design elements to make the information more accessible
Compassionate Use Program
Galapagos is committed to advancing the development and commercialization of novel medicines. We highly encourage patients to take part in our clinical trials, as they play an indispensable role in generating the data needed for the evaluation and approval of investigational products.
In exceptional circumstances where patients are unable to participate in clinical trials and have exhausted all available treatment options, Galapagos may explore providing an investigational product through our “expanded access” program, also known as “compassionate use”.
For detailed information about our expanded access program, please refer to Galapagos’ policy on providing investigational products outside of clinical trials.
It’s important to note that at present, Galapagos does not have active compassionate use programs for any indications.
Innovating together!
Galapagos supports external research activities that complement our product pipeline and clinical expertise, adding medical knowledge. This external research can supplement the comprehensive data generated in registration studies by supplying valuable information about the safety, efficacy, pharmacology and tolerability and economic value of our drug candidates and medicines.
Galapagos supports external research through unsolicited funding requests. These are evaluated through our Investigator Sponsored Research (ISR) process.
Dear Investigator,
Thank you for your interest in Investigator sponsored research (ISR). Kindly note that Galapagos is currently not supporting any new ISR proposals. New guidance on areas of interest and review timelines will be provided in due time. Please contact your local MSL should you want to further discuss.
To be eligible for funding, the proposed research activity must be
The ability and experience of the investigator(s) will be considered, and the feasibility of the study will be assessed.
New guidance on areas of interest and review timelines will be provided in due time.
Your request will be reviewed by our cross-functional committee that may suggest to improve the scientific merit of the proposal and enhance consistency with Galapagos’ approval criteria described above. However, the study sponsor, the principal investigator will have full and final discretion and responsibility for all aspects of the study design, implementation, data analysis, and data dissemination, including compliance with all laws and regulations applicable to research sponsors.
The terms under which Galapagos will supply support are described in a signed contract. Galapagos gives no guarantees that the external research support supplied will fully fund the entirety of your work, and Galapagos is thus not liable for changes in budget after acceptance.
Our stories
We curate a range of inspiring stories about how we are #LivingInnovation at Galapagos
Pipeline
We focus on the key therapeutic areas of immunology and oncology, where we have developed a deep scientific expertise in multiple drug modalities, including small molecules and cell therapies.
Galapagos Health
Are you a healthcare professional? Visit our Galapagos Health portal for information about our therapeutic areas and indications, medical education, congresses and events and product information