Our industry is at an interesting crossroads. On one hand, pressure to share clinical and real world data is increasing. The necessity for global data sharing has been magnified by the pandemic. Ambitions to accelerate research and the race for vaccines have been heightened by intense societal and economic need. This acceleration is taking place inline with significant technology development that has made it possible to access, process and share sensitive personal data in ways we have never contemplated.
This has given rise to two competing demands. First, the need to share health data with others as a means to accelerate research. Second, the need to protect personal health data and patient identity. Health regulators around the globe are instituting new policies to address both.
Along with these evolving needs, technology that enables the systematic assessment and transformation of health data as a means to best protect patient privacy is a critical consideration. Governmental health regulatory agencies, specifically Health Canada, EMA and the FDA are identifying, creating, and altering policy to address health data sharing expectations and acceptable disclosure risk thresholds. This includes patient and trial participant privacy considerations and the use of data anonymization (applying qualitative and quantitative risk assessments) as a viable solution to measure the likelihood of patient reidentification. Below is an overview of each regulatory branch and their current policy/position.
Health Canada PRCI, enacted in 2019, is emerging as the front runner in public policy relating to data sharing and anonymization of clinical trial results. The Health Canada PRCI guidance document specifically lays out its principles for protecting personal information, applying the “serious possibility” test to determine when information is about an identifiable individual. The document goes on to state that clinical information must be adequately anonymized (vs. outright redacted) prior to public disclosure to avoid the possibility of re-identifying individual clinical trial participants. Further, acceptable methods of data anonymization must be conducted on any potentially identifiable clinical data. Health Canada PRCI goes on to delineate the following practices for data anonymization:
EMA Policy 70 sets guidelines for Pharmaceutical Sponsors for publishing clinical data to enable public scrutiny of trial conduct and outcomes and to advance the application of new knowledge to future/secondary research purposes. While stating that the protection of personal data is paramount, EMA Policy 70 lays out its vision for clinical trial transparency as follows:
A high degree of transparency will take regulatory decision-making one step closer to EU citizens and promote better-informed use of medicines. In addition, the Agency takes the view that access to clinical data will benefit public health in future. The policy has the potential to make medicine development more efficient by establishing a level playing field that allows all medicine developers to learn from past successes and failures. Furthermore, it will enable the wider scientific community to make use of detailed clinical data to develop new knowledge in the interest of public health. Access to clinical data will allow third parties to verify the original analysis and conclusions, to conduct further analyses, and to examine the regulatory authority's positions and challenge them where appropriate. . 1
EMA Policy 70 focuses its evaluation of effective anonymization based on the following criteria:
An anonymization solution preventing all three of the above criteria is considered robust and therefore sufficiently anonymous according to the EMA.
FDA (Food and Drug Administration) Transparency Statement
The FDA appears to be watching the global trends. While it has no official policy, in its latest statement on clinical trial transparency, it states:
To realize the benefits and opportunities provided by a more transparent drug approval process, we must first identify, and address, some of the challenges facing the global drug development community. The FDA is committed to improving collaboration efforts with drug-approving regulatory agencies in other countries, and to increasing transparency related to the scientific basis for drug approval decisions. The FDA is working on multiple fronts to support these efforts and apply best practices.2
It stands to reason that as Health Canada PRCI and EMA Policy 70 advances, it may only be a matter of time until the FDA releases a more robust and up-to-date set of policies and guidelines with respect to clinical trial data and document disclosure. In the meantime, many global pharmaceutical sponsors are taking the “lowest common denominator” approach - meaning, they will combine the most stringent policies and guidelines and apply them in practice at a global level.
Real Life Sciences, LLC works with clinical trial managers, R&D teams, investigators and researchers to provide the following services: Automated redaction and anonymization of clinical and real-world data and documents and qualitative and quantitative risk assessments process and workflow automation, expert regulatory knowledge and strategy and process consulting.
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