The European Medicines Agency (EMA) has put out for consultation a draft policy on access to clinical-trial data that includes three different levels of access, together with corresponding conditions for publication and use, depending on the type of data involved.
For example, data defined as ‘commercial confidential information’(CCI) would not be put in the public domain, although the EMA sees this restriction applying to only a small number or proportion of clinical-trial documents/datasets.
At the other end of the scale, clinical-trial data, information or documents not subject to CCI restrictions or existing safeguards for the protection of personal data (PPD) – a principle “enshrined in EU legislation” and “a fundamental right of EU citizens” – would be available to download from the EMA website when the agency published its European public assessment report (EPAR) on an application for centralised marketing authorisation.
This level of access would apply regardless of whether the EMA’s decision were positive, negative or a product withdrawal.
Inbetween these two poles would fall clinical-trial data that raised PPD concerns. These would be available through a controlled-access procedure involving two “complementary” levels of protection providing the “best-possible assurance against retroactive patient identification”.
Under the proposed conditions for controlled access to clinical-trial data, data would need to be “adequately de-identified according to a recommended minimum standard”, the EMA proposes.
Moreover, access would only be granted subject to a number of requirements, such as signing a data-sharing agreement.
The gradated levels of access envisaged in the EMA’s consultation document would extend only prospectively to clinical-trial data filed with the agency after the policy came into effect (i.e., after 1 January 2004, according to the current timetable).
All other clinical-trial data currently held by the EMA (e.g., for marketed products), or pre-existing data for marketed products submitted to the agency in the future (e.g., as part of a referral procedure), would “continue to be made available to external requesters on a ‘reactive’ basis as outlined in the Agency’s
current policy on access to documents”, the draft policy notes.
Pharmacovigilance data based on Individual Case Safety Reports (ICSRs) would also be outside the scope of the policy.
The draft document sets out in more detail what kind of clinical trial data would qualify for open access, controlled access or non-disclosure due to commercial confidentiality, as well as the various conditions that would apply in a controlled-access scenario:
Category 1 data with restricted access. These might be details of the investigational medicinal product itself, some in vitro studies or bioanalytical data characterising the product.
However, this information “will only be deemed CCI in duly justified cases” and relevant data could still be requested under the EMA’s policy on access to documents.
In general, the agency stresses, clinical-trial data “cannot be considered CCI”. Moreover, the “interests of public health outweigh considerations of CCI”.
- Category 2 data for open access. These would be documents that did not raise any PPD concern because, for example:
- - The document did not include any personal data in the first place (e.g., summary tables presenting only aggregated data.
- - Any personal data in the document had been adequately de-identified.
- - There were public-health reasons overriding data-protection legislation.
Category 3 data for controlled access. These would be clinical-trial data/documents that raised PPD concerns – in other words, all documents, data and information contained in a ClinicalStudy Report and not falling under Category 2: “essentially 'raw' CT data”, the EMA says.
(Under parliamentary amendments to the European Commission’s proposed regulation on clinical trials, sponsors in the EU would have to publish full Clinical Study Reports once a marketing-authorisation decision had been taken.)
Controlled data access would apply where the “goals of transparency and PPD have to be carefully balanced against each other, and proactive publication (as is foreseen for Category 2 documents) is not an option”.
The data concerned would be subject to a minimum standard of de-identification and a number of conditions for access, such as a legally binding data-sharing agreement confirming that access would be for the “sole purpose of addressing a question or conducting analyses that were in the interests of public health”, and including an “exhaustive and detailed list” of the aims of accessing the data.
Other conditions would include commitments not to try to identify patients retroactively from the clinical-trial data; not to share the data with anyone else; not to use the data to gain a marketing authoriation in a non-EU jurisdiction; to make all of the results of the analysis publicly available within a “reasonable” period of time (usually one year after accessing the data); and to destroy all the data accessed once the analysis were complete.
Balance and reconcile
The general gist of the draft policy is to balance and reconcile competing objectives such as:
The drive for transparency of clinical-trial outcomes.
Improving the efficiency of drug development.
Protecting personal patient data and the boundaries of informed consent, as well as commerciallyconfidential information.
Addressing the adverse consequences of inappropriate secondary data analysis (a true open-access policy cannot guarantee against this, but the EMA will “put in place measures to ensure the best-possible protection of public health (and regulatory decisions) against claims resulting from inappropriate analyses”, it says).
Ensuring future investment in biopharmaceutical research and development.
Part of this reconciliation, the EMA notes, is making sure that transparency is a two-way street.
The agency “takes the view that those who make secondary use of patient-level CT data shall be held to the same standard of transparency as those who generate CT data in the first place; hence, all secondary analyses shall also be in the public domain and accessible for further scrutiny by the scientific community”.
The EMA's policy document can be accesssed online at:
Stakeholders have until 30 September 2013 to submit their comments on the agency’s proposals