The issue of transparency and disclosure of clinical trial data has been growing over the past few years. Clinical trials are essential in offering new therapies to patients. However, individuals participating in these trials put themselves at risk, and therefore, the medical community is obligated to derive as much benefit from that risk as possible.
Disclosing clinical trials information and creating transparency around the derived data are key steps toward maximizing that benefit, increasing trust between the public and the industry, providing data that could spur new products or therapeutic approaches, and potentially avoiding unnecessary trials.
However, data sharing carries its own risk, especially regarding personally identifiable information (PII; such as names, phone numbers, email addresses), protected-personal data (PPD; also includes subject or patient ID numbers, event profiles, etc.), and company confidential information (CCI; such as trade secrets). Sensitive information must be identified and redacted PRIOR to releasing documents to the public. In this blog post, I’ll discuss what the changes to European Medicines Agency (EMA) Policy 70 mean for your business and suggest how to achieve compliance with this new transparency and disclosure mandate.
What are the requirements under Policy 70 to ensure compliance?
In January 2015, the EMA released new transparency and disclosure rules related to clinical reports contained in Marketing Authorization Applications (MAAs) submitted on or after that date (under Policy 70). Specifically, these are clinical study reports and sections 2.5 Clinical Overview, 2.7.1 Summary of Biopharmaceutics and Associated Analytical Methods, 2.7.2 Summary of Clinical Pharmacology Studies, 2.7.3 Summary of Clinical Efficacy, and 2.7.4 Summary of Clinical Safety. The first reports subject to Policy 70 are expected to be made publicly available in September 2016. The EMA is currently going through their backlog of MAAs submitted since January 2015 and advising sponsors of their redaction submission due dates. In early March 2016, the EMA published detailed requirements that expand the breadth and depth of the original rules in significant ways, including the following:
- Redaction of patient narratives
- Identification of CCI and delivery of a table to describe the justification for what the sponsor classifies as confidential
- Validation that CCI is not currently disclosed in the public domain
- Provision for an anonymization report — the purpose of the report is to explain how the sponsor anonymized the submission to reduce the probability of re-identification of patients and study personnel
Aside from these requirements, the EMA has also provided explicit rules as to what is deemed PPD and CCI; previously, this determination was left to the sponsor.
What is the timeline for redacting and publishing clinical reports?
Short-term considerations regarding Policy 70
- Patient narratives: Policy 70 states that narratives are to be included in the redaction package and anonymized, rather than removed from clinical study reports. This has introduced the most challenging aspect of PPD redaction, with narratives composed mostly of private information and individual outcomes.
- CCI justification table and validation: The EMA will evaluate all proposed CCI redactions. Therefore, all information proposed for CCI redaction should be labeled to indicate that the proposed redaction is requested on the grounds of company confidentiality. Sponsors must justify redactions for CCI. Prior disclosures of information in the public domain such as in a scientific publication invalidates a claim of CCI.
- Anonymization report: The anonymization report is required with the initial redaction submission package. This report describes the anonymization process followed, the methods used, the rationale for data transformations/redactions required to anonymize the data, and the impact on data utility. The information presented in the anonymization report should not lead to an increased risk of re-identification.
Multiple techniques for anonymization
The Policy 70 guidance also discusses various anonymization techniques, each with its own strengths and weaknesses. Ultimately, the aim is to preserve data utility while ensuring adequate anonymization. The simplest method is removing information that allows identification of an individual. This technique is sometimes called masking. Apart from masking, the main anonymization techniques are randomization and generalization. Randomization alters the data to remove the link between the data and the individual. The other main technique is generalization of the attributes of the data by modifying the respective scale or the order of magnitude. An example would be a trial participant who was born on 19 August 1978. This birth date would be generalized to 1970-1980.
Any combination of anonymization techniques chosen must ensure an acceptably low risk of re‑identification and that the resulting data transformation will not impact study result interpretations.
How will Policy 70 affect regulatory and medical writing?
As you can imagine, Policy 70 will alter the conduct of medical writing. For example, the public domain comparison mandate will make sponsors rethink about what information they include in publications and online portals such as ClinicalTrials.gov and EudraCT as any information disclosed in these domains cannot be redacted as CCI at a later date. Moreover, sponsors will need to allocate more time and resources to ensuring that they achieve compliance with Policy 70 and meet the associated deadlines.
While Policy 70 mandates proactive disclosure of clinical trial data, the EMA’s Policy 43 supports reactive disclosure of requested clinical trial documents. As time goes by, the relationship between policies will continue to evolve. On one hand, Policy 43 requirements could start to look more like Policy 70. Alternatively, Policy 43 could become an avenue for less conservative redacted documents for research and other purposes.
Preparing for Policy 70
The risk of mistakenly posting PPD or PII publicly is significant and potentially debilitating.
Understanding human limitations, the complexity of redaction efforts, and the implications of errors hinders compliance with transparency initiatives as well as legal ramifications. Ensure that you are planning well in advance and have all the key stakeholders at the table.
Learn more about meeting transparency and disclosure initiatives
Are you struggling to integrate these initiatives into your processes? Please watch this webinar to get some tips on how to facilitate Policy 70 compliance.