Data collected on patients treated in clinical trials to support approval of drugs and devices, was always considered to be confidential but with the introduction of policy 0070 from EMA, data will be shared from now to fuel future research and affirmation of current research. This is mark of revolution in clinical research where industry is supporting this change. Big pharma giants are open to share data and looking forward for streamlined policies to implement it.
EMA requires applicant to submit anonymized clinical documents as well with original clinical document for clinical data submitted under the centralized marketing authorization procedure. Phase 1 scope covers clinical documents mentioned below:
- Module 2.5 (clinical overview)
- Module 2.7 (clinical summary)
- Module 5 (clinical study reports (CSRs) and Appendices 16.1.1 (protocol and protocol amendments), 16.1.2 (sample case report form) and 16.1.9 (documentation of statistical methods)).
Initially, EMA proposed to anonymize documents mentioned above but recently updated their external guidance document to be more specific on do’s and don’t. Following are few highlights of updated document around scope:
- “Case narratives should not be removed nor redacted in full regardless of their location in the clinical reports (body of the report or listings). They should be, instead, anonymised.”
- IPD listings contained in CSR section 14.3.4 “Abnormal Laboratory Value Listing” can be considered out of scope of phase 1 of Policy 0070. But aggregated patient data listings within section 14.3.4 “Abnormal Laboratory Value Listing” should NOT be removed.
There is always a risk of leak of personal information in documents and redaction involves masking all personal information in clinical documents. Policy suggests redacting Protected personal data (PPD) and Commercially confidential information (CCI) with specific labeling and color coding. But redacting everything may lead to loss in data utility and purpose of publishing clinical documents will fail. Thus, there need to be proper balance in level of anonymizing documents, risk of re-identification and data utility. Most of the submissions done till now, since the implementation of policy, are following qualitative approach for risk, utility and level of anonymization. EMA wants to move to quantitative approach and following statements in guidance document makes it clear about the future implementation:
“It is acknowledged that initially anonymization will involve reactive data anonymization where the assessment of risk of re-identification may be mostly qualitative”
“Applicants/MAH are encouraged to use quantitative methods to measure the risk of reidentification as soon as they are in a position to do so.”
“Applicants/MAH may not follow, in an initial phase, an analytical approach, and therefore it will not be necessary to calculate the risk of re-identification.”
GCE has developed a team to handle all the requirements under Policy 0070 and has ability to provide both qualitative as well as quantitative approach to meet these requirements.