KEY TAKEAWAYS
- Pharmaceutical companies that sponsor clinical trials are required to balance the need for transparency with protecting confidential information. This is achieved by redacting confidential details from documents before they are made public.
- The redaction process is often hindered by inefficient systems, which can lead to delays. Implementation of a range of practical tips can streamline and simplify the process.
Health authorities, including the European Medicines Agency and Health Canada, require detailed information to be made public as part of clinical trial registration and reporting. This is critical for transparency, but can present practical challenges for pharmaceutical companies as they seek to meet these criteria while protecting intellectual property. Redacting confidential information from documents before public release is an accepted solution, but it can be an onerous and inefficient process. In a recent article for the European Medical Writers Association’s journal, Medical Writing, Elliot Zimmerman outlined the challenges involved, along with a series of practical solutions.
Pitfalls and challenges
As detailed by Zimmerman, the redaction processes followed by pharmaceutical companies can be fraught with inefficiencies, including:
- Decisions on which details are confidential are often made across multiple teams.
- Changes to the classification of confidential information across the research cycle, as information is released into the public domain, make it difficult for teams to keep up to date with changes to confidential status.
These factors contribute to high rates of redaction rejection by health authorities: 60% of sponsor-requested redactions are rejected by the EMA and 65% by Health Canada.
These factors contribute to high rates of redaction rejection by health authorities: 60% of sponsor-requested redactions are rejected by the EMA and 65% by Health Canada.
Practical solutions
Zimmerman proposed a number of practical solutions to ease the burden of redaction:
- ensure processes, roles, and responsibilities are clearly defined, including between teams
- implement a centralised ‘library’ to track confidential information
- ensure a common understanding of what constitutes confidential information across teams
- only include necessary information in documents from the outset and cross-reference within a document, rather than duplicating information
- use integrated management and tracking systems.
Through implementation of these approaches, sponsors could streamline and simplify the redaction process and, thus, reduce delays in clinical trial registration and reporting.
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