Data transparency has been an important issue for the EMA over the past few years and it launched a policy document in 2014 which drug development companies must now comply with. Several large pharmaceutical companies have already publicly expressed their support for clinical data transparency by publishing clinical data results in the EMA’s portal.
The new EMA guidance requires clinical trial Sponsors to make Clinical Study Reports available within 60 days of a marketing authorization decision “in a form that removes any risk of a subject’s identity being breached”. While the impending November deadline approaches, the regulation focuses on Clinical Study Reports (CSR) for the time being but indicates the patient-level data behind CSRs will be treated the same way in the future.
Why Focus NOW on Patient-Level Data
Rushing to define a strategy for electronic redaction of patient information doesn’t seem like a long term option. Relying on low cost or off-shore options could only result in poor data quality or a lack of standardization across multiple studies. With the November deadline, companies will risk penalties for not complying with the guidance. Therefore relying on an overall strategy for clinical data transparency at the patient-level seems the wiser choice.
Steps towards anonymization and transparency should begin at the patient-level where data is more structured and managed in a systematic way.
As a CRO focused on data-centric services, CROS NT recommends some proactive strategies companies can take to prepare for the EMA requirements:
- Centralizing Clinical Data
Keeping all data with one specialized vendor is surefire way to keep patient-level data standardized and traceable. Aside from re-using existing CRF page, the team can build an anonymization plan into the Data Management Plan and Statistical Analysis Plan to include requirements for the database build, data collection and data standards to be used. The Data Management and Statistical team will also ensure a similar compliant and anonymized strategy in mind for analyses and reports.
- Include the Medical Writer in your Team
The CRO should include an experienced Medical Writer in the biometrics team who is familiar with EMA regulations and EudraCT submissions and who can perform redaction of patient identifiers in the Clinical Study Report if needed. The Medical Writer should understand the data strategy and statistical analyses in relation to patient identifiers prior to writing the CSR.
Looking for a data-centric CRO to build your clinical data strategy to include a data anonymization plan? Contact CROS NT to consult our statisticians and regulatory experts.