Achieving Clinical Trials Transparency
Recent policy changes by Europe’s regulatory authority for drugs and devices has rekindled the pharmaceutical industry’s focus on clinical trials transparency. While there have been many initiatives to enhance openness in drug trials, the European Medicine Agency’s (EMA) requirement to make a trial’s clinical study report (CSR) publicly available is seen as a revolutionary move to boost public trust in the drug approvals process.
As the comprehensive report that details the protocol and results of a clinical trial, the CSR can contain highly sensitive health information about the study’s participants — placing the issue of patient privacy front and center. It also leaves many in the biopharmaceutical community wondering how to meet the EMA’s new transparency requirement while remaining compliant with privacy legislation and protecting their own confidential information.
How biopharmaceutical companies choose to anonymize their clinical trial data and reports have serious implications for transparency and their ability to leverage data for secondary uses. On the surface, different approaches to protecting the privacy of trial participants may appear to be equally sound, but they can have vastly different results when it comes to the usefulness of the anonymized content for subsequent analysis.
Understanding the drawbacks and benefits of the different methods for anonymization can help pharma companies better position themselves for the future. By aligning with best practice guidelines, they will not only be able to meet new transparency mandates but do so while complying with privacy regulations and maximizing the quality of data that can be shared for secondary purposes.
Make sure to download your copy of Achieving Clinical Trials Transparency today to learn how your organization can balance the demands and risks of data sharing.
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