Finding Clinical Trials Transparency
Initiatives to improve clinical trial transparency have historically focused on registering clinical trials and publishing summary trial results. Now, recent actions taken by the European Medicines Agency (EMA) aim to radically improve transparency in the drug approvals process.
Last year the EMA implemented Policy 0070, which requires publication of a drug trial’s clinical study report (CSR) if that drug receives market authorization. Making the anonymized CSR publicly available on the web is seen as a significant step on the path to transparency. The document provides extensive details on the clinical trial, including the study objective, the investigational plan and study design, the evaluation and analysis were done, and specifics about the patients who participated.
It is this last item in particular — detailed information about the experience of the study’s participants in the trial — that creates huge privacy concerns and has the biopharmaceutical community wondering how to meet the EMA’s new transparency initiative while remaining compliant with privacy legislation. Publishing the CSR, or sharing the individual participant data (IPD) that is at the heart of any clinical trial, introduces a risk to the privacy of the trial’s participants.
While most patients support the use of their data for the betterment of patient care, they want assurance that their privacy is maintained. This has resulted in an emphasis on how to best safeguard patient privacy as it pertains to clinical trials. Biopharmaceutical industry groups, as well as organizations like the Pharmaceutical Users Software Exchange (PhUSE) and the Institute of Medicine (IOM), have published guidelines on how to minimize the risk of re-identification when sharing clinical trial data. However, some of these methods offer a more sound approach than others.
Clinical trial transparency is coming to a critical juncture. External forces pressing for greater transparency are meeting with internal drivers to leverage data for secondary uses. Both require the ability to deliver high-quality, de-identified data. Where once the conversation focused on whether clinical trial data should be shared, it is now focused on when data should be shared and how to do it. The way that study sponsor chooses to anonymize their clinical trial data has serious implications for both transparency initiatives and secondary use.
Make sure to watch our recent webinar discussing Anonymization for EMA Policy 0070 – we will describe methods for the anonymization of clinical reports, and methods for measuring the risk of re-identification for such documents, with examples comparing anonymization techniques with redaction techniques.