Clinical trials should remain transparent
Brussels - An important trial between the European Medicines Agency (EMA) and a pharmaceutical company is currently taking place before the Court of Justice of the European Union. The dispute concerns the application of the publicity principle and, in particular, the publication of clinical research reports.
The Anticancer Fund is following with great interest the trial on transparency of clinical studies. The ruling of the Court of Justice is expected on Wednesday, January 22.
The consequences of this process are far-reaching for all parties who are advocating studies in the interest of the patient, regardless of the disease involved.
Patients decide in consultation with their doctor about the treatment of their disease. For this they need access to well-documented and understandable information about their possible treatment options. Since 2016, the European Medicines Agency (EMA) has systematically published study reports on their website. These reports are an important and reliable source of information for both caregivers and patients. They help to better put the efficacy and safety of a medicine in perspective. If the industry wins the trial and the clinical study reports remain secret in the future, it would mean an outright blow to EMA's transparency policy.
For this reason the Anticancer Fund along with Test-Aankoop, Kom op tegen Kanker and het Belgisch Centrum voor Farmacotherapeutische informatie (BCFI) are sounding the alarm.
Read more about the risks of the outcoming of the trial on the press release (in Dutch) that was sent out: