Public Consultation Examines Potential Confidentiality Issues with New European Clinical Trial Regulations
Since January 21, the European Medicines Agency (EMA) has been holding a public consultation on the new European Clinical Trial Regulations (CTRs), which are intended to streamline the application process for clinical trials and increase the availability of information and results. However, the CTRs have met with some concerns regarding commercial and patient confidentiality. As described by Reed Smith attorneys John Wilkinson, Nicola Maguire and Adam Lewington in “European Clinical Trial Regulations Public Consultation – Confidentiality Concerns,” the new CTRs propose two exceptions for the disclosure and publishing of clinical trial information on the EMA’s publically accessible portal and database. These exceptions would allow clinical trial sponsors to withhold information that could compromise economic interests or be classified as identifiable personal data. The public consultation concludes today (February 18), with results of the consultation being published thereafter.
To read the client alert, click here.