Developing new medicines is complex and can take time. Many years can pass from the first promising laboratory result until a new medicine is available for use in the real world. It is only after we have tested effects of a potential new drug in humans that we can know for certain if patients will benefit from the new treatment. To make this a reality, we depend on those that are willing to take part in clinical trials: healthy individuals and patients.
Written by Heidi Müller
Given the nature of clinical research, and despite the strong safeguards and clear regulations that are in place, it can mean that participants expose themselves to potential risks. Joining a clinical trial can be a demanding experience and requires some courage to help bring what is likely a much-needed medicine to the market.
At Galapagos, we believe that establishing a trust-based relationship with clinical trial participants, from the start, leads to greater engagement all along. The starting point for us is to help them better understand the requirements of the trial so that they feel confident about giving their consent to participate in it.
As part of the requirements for conducting a clinical trial, we have 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
This effort resulted in a new form that is easier to understand and will help people in their decision to participate in a clinical trial.
About Heidi Müller (Head of Site & Patient Engagement at Galapagos)I’m Heidi Müller. I have been working in the healthcare sector for 35 years. I joined Galapagos last year as Head of Site & Patient Engagement. Together with my team, my aim is to engage with patients, clinical trial sites and our internal study teams, to understand and build upon everyone’s needs. Ultimately, our aim is to create the best (clinical trial) experience for all. It’s my way of ‘Pioneering for Patients’.