Using lay language when publishing the results of clinical trials should be a no-brainer – but it took a long time to get there.
What is the most surprising challenge you faced while working in the area of Clinical Trial Transparency?
Actually, I find it surprising that it took so long to come up with the idea of publishing the results of clinical trials in lay language, like now explicitly mentioned in the EU Clinical Trial Regulation. In the end we want to develop drugs for patients and we need the support of patients in all our clinical trials. This being said: non-scientific people like patients or their relatives should be provided with information they can understand.
What has proved to be successful in building patient-centric culture in companies?
Raising the topic in all functions, connecting the dots, talking to patient organisations, actively searching for patients’ feedback.
Sigrid ACHENBACH is a lawyer by training, but has been working in the pharmaceutical industry for more than 14 years. Since 2012 she has been providing legal advice on global clinical development matters, including Regulatory and Quality topics. Since December 2019 she is the Head of Clinical Trial Transparency at Bayer.