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Faced with new EMA guidance on anonymizing clinical trial data, drug manufacturers have two choices – do what it takes to meet the November deadline and prioritize clinical study reports, or embrace a more sustainable strategy that starts with the patient-level data.
The pressure is increasing for life sciences to be more open about their clinical trials results. In March, the European Medicines Agency (EMA) issued detailed guidance based on its 2014 Policy 0070 for clinical trial reporting: from November this year organizations will need to make anonymized CSRs available within 60 days of an authorization decision. Given the timeframe, it would be tempting to start where the initial need is â i.e., the CSR. But it is only a matter of time before all of the patient-level data behind those reports will have to meet the same requirements. The smarter approach to patient anonymization then is to start here, with the underlying data - because everything else flows from that. It is also the only way to ensure that study findings retain their scientific meaning and value. Ambiguity could create more work down the line, once clinical trial findings are in the public domain and questions arise. The risks of taking shortcuts can already be seen. Some firms have begun to engage external agencies, including offshore resources, to process CSR documents. Their role is to apply formulae to shield patients’ identity (electronic redaction is not an option, according to the new guidance). Yet the focus on speed has in certain instances led to consistency and quality issues, requiring some work to be redone. Another approach, which is not to be recommended for its efficiency, is to re-run reports using compliant, anonymized patient references. Adopting a more holistic strategy will be more economical in the long term. Patient-level data is structured and well organized, allowing any transformations to be done systematically and comprehensively in a few simple steps. (An entire clinical study’s worth of data can be processed in a single day.) Amending study reports is then simply a matter of intelligent search and replace; the hard work has already been done. Expecting transparency requirements to grow, and building anonymization options into the original processes, is the best way life sciences organizations can stay ahead of the evolving requirements and minimize their risk. Dave Handelsman is the Senior Director of Industry Strategy at d-Wise