June 25 2013 | By Márcio Barra
The European Medicines Agency (EMA) has just released for consultation a draft policy on access and transparency of clinical-trial data. This draft details three levels of access according to the type of data, alongside rules for publication and use.
The objective of this draft policy is to balance and reconcile the following objectives:
- Be a driver to improve transparency of clinical trial data.
- Improve the efficiency of drug development.
- Protect personal patient data and the boundaries of informed consent, as well as commercially confidential 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 against claims resulting from inappropriate analyses”, the draft policy says).
- Ensure future investment in biopharmaceutical research and development.
The categories of CT data are:
CT data/documents containing CCI (Commercially confidential information (“CCI” documents): Some clinical trials may contain CCI. The CCI can be details of the investigational medicinal product itself, in vitro studies, or any other kind of data. Data defined as ‘CCI would not be put in public domain. The EMA predicts that this restriction would apply only to a small number of clinical-trial documents/datasets.
CT data/documents without protection of personal data (PPD) concerns (“O” documents): Documents where PPD is not an issue for concern. This may be because the document does not contain personal data in the first place, any personal data in the document have been adequately de-identified, or there are public-health reasons why personal data can be made public.
These documents are open access. Their data will be available as downloads from the Agency’s website, when the European Public Assessment Report (EPAR) for positive decisions, negative decisions or withdrawals is published.
CT data/documents with PPD concerns (“C” documents): All documents, data and information contained in a Clinical Study Report that do not fall under the “O documents” category. These are essentially ‘raw CT data’. In these cases, the transparency of the data and PPD has to be carefully balanced against each other, and proactive publication, like in “O documents”, is not an option. Therefore, all CT data with PPD concerns are ‘controlled access’, on a case by case basis. Access would only be granted subject to a number of requirements, such as signing a data-sharing agreement.
The policy comes into effect on 1 January 2014. Check it out through this link.