Using the EMA clinical data portal
The European Medicines Agency's clinical data portal is the website where the clinical data published under Policy 0070 appear. What a user may do there depends on the type of access they register for. The site offers ways to browse, search, export and download the published documents, and it holds summary data rather than individual patient data.
Who can read and who can download
There are two categories of access, each with its own terms of use: access for general information purposes, and access for academic and other non-commercial research purposes. An account is needed even to read the published data. Creating one means completing a self-service registration form with personal information and answers to several security questions, after which an email notification supplies the registration information needed to reach the site. A user who accepts an access category's terms of use agrees to be bound by them, and has to reconfirm them on every visit. For one user, the hardest part of getting access was working out where to look in the first place, and once past that it was not too bad.
Access for general information purposes is open to everyone, regardless of geographic location. It covers general information and other non-commercial purposes, including non-commercial research. It allows documents to be read on screen only, and does not allow them to be downloaded, saved, edited, photographed, printed, distributed or transferred.
Access for academic and other non-commercial research purposes is more flexible: it allows documents to be searched, downloaded, saved and printed, to be used solely for those purposes. Registering for it requires additional personal data, including a date of birth and a passport or identity card number with the document's expiry date. It also requires an address in the EU, a requirement that cannot be circumvented because the registration form's drop-down menu shows only the EU member states. So this access is effectively open only to EU residents. For example, two EU citizens residing outside the EU could therefore access the site only for general information purposes. One user thinks that people from the UK could still access the site easily in 2016, while the UK was part of the EU. The same user thinks that UK citizens trying to register since Brexit have probably had quite a lot of difficulty.
Getting research access from outside the EU
A user residing outside the EU can use the services of a third party resident or domiciled in the EU, and the terms of use then treat that third party as the user. For example, one writer residing outside the EU upgraded to research access this way, with her company's affiliate in Germany as the third party.
A user outside the EU who wants to download documents can also write to the agency to ask for permission. One writer living in Switzerland, outside the EU, wrote to the agency that the access was really needed for educational purposes, and was granted it. A writer based in Switzerland who contacted the agency was given information on how to upgrade from general information access to research access, which the terms of use make possible.
The portal's home page
Once logged in, the portal shows the terms of use, and gives a very prominent place to reporting a patient re-identification and to data protection, which one user takes as a sign that the agency takes this seriously. The home page has several tabs that help users, the last two of which are very important for data protection:
- The first tab gives the terms of use.
- The "how to" tab is a very helpful user's tool that also gives additional information, such as the most viewed clinical data to date.
- The "report patient reidentification" tab is part of the re-identification alert mechanism that ensures the privacy of patients is protected.
- The "data protection" tab is about protecting the rights of the registered user, and details how the agency collects, processes and stores the data provided during registration.
Searching and exporting results
Once granted access, a user can search the site in two ways, by browsing or by advanced search. Browsing works by product name, by marketing authorisation holder name, or by type of product or type of approval. Advanced search takes search terms, such as a product or an ATC code, with additional filters such as date of publication and procedural type.
The results can be downloaded as a table in CSV format and opened in spreadsheet software such as Excel. The export gives each product's name, active substance, marketing authorisation holder, status, publication date, procedure type and ATC code. Further columns say whether the product is generic, biosimilar, conditionally approved, approved under exceptional circumstances, an orphan or an Article 58 procedure, and whether it was withdrawn, and give its procedure number and number of documents. In one example export of four procedures, the number of documents ranged from 11 to 105.
Downloading a procedure's documents
Downloading requires accessing each procedure individually. Within a procedure, the reports are grouped into four categories: clinical overview, clinical summary, clinical study reports and anonymisation report. Clicking a category's "+" sign shows the documents under it. For example, the documents of one application include the clinical overview, the clinical study report body, the clinical study report appendices, the protocol, the case report form, the statistical analysis plan and the anonymisation report. All documents within a procedure are searchable using text or keywords. The whole procedure or selected documents within it can be downloaded, as PDFs that are not hyperlinked.
What the portal does not hold
The portal holds summary data, the Section 14 material, rather than individual patient data. There is hope that individual patient data will become available at a later date. Tables, figures and listings are reportedly planned to be published as well.