The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued recommendations for EU policymakers on the use of shared electronic medical records in clinical research.
Industry representatives argue for structures that guarantee both patient privacy and make clinical research more efficient.
The recommendations were made public at the Drug Information Association’s (DIA) Annual EuroMeeting, Barcelona, in March.
The guidelines were further discussed in Berlin, at the German health-IT conference, conhIT 2008 this week, in a special session on the ‘secondary use’ of electronic patient data for medical research.
Initial feedback from the US shows that using shared EMR solutions for clinical research is particularly attractive to the pharmaceutical industry.
The records could, for example, be used to automatically identify potential clinical trial candidates.
Talking to E-Health Europe, EFPIA-expert Mats Sundgren, head of Global Clinical Development at AstraZeneca, described the scope of the potential benefits: “Under optimal conditions, it takes a pharmaceutical company 100 days to find 2,000 potential participants for a clinical study. In a fully digital care network in the US, we recently managed to identify 2090 candidates within 24 hours.”
Such a reduction in time offers huge cost savings: “If digital structures were available and could be used, the pharmaceutical industry could save €1bn to €2bn annually in Europe alone,” said Sundgren.
“The key will be to have an EU-wide policy to guarantee trust and security. It must be guaranteed that the data is dealt with confidentially, and that it is pseudonymised or anonymised properly.”
EFPIA argues that trust can only be built up if EU-wide regulations come into place, given that shared electronic medical records are being implemented in an increasing number of EU member states. Specifically, EFPIA aims:
1. to develop a transparent and consistent definition of electronic patient records;
2. to nurture transparency and cooperation across EU member states
3. to identify benefits of cross-border utilisation of information contained in EMR;
4. to define good practices in privacy enhancing techniques;
5. to develop accreditation mechanisms and model contract terms for trusted third parties (TTP);
6. to establish professional certification mechanisms for medical researchers regarding EMR data.
Central to EFPIA’s recommendations, lies the concept of TTP that act on a national level. They would be the ones to gather data from the different patient records and to make them available to researchers from research institutions or from industry.
For example a pharmaceutical company that wants to conduct a clinical study could contact a TTP, and possibly conduct anonymous research of the medical database in order to, for example, identify patients for its study. The TTP, then, would contact the respective patients and ask them if they were willing to take part in the study.
EFPIA has an idea about who should be put forward as a TTP. “We do not consider it a good idea that it is an institution from within the healthcare system because of potential conflicts of interest”, said Sundgren. Rather, an independent body should do the job, for example an IT or security company.
Sundgren stressed that, in EFPIA’s view, Denmark, for example, was moving in the right direction. Denmark has built up a nationwide electronic patient record system in recent years, managed by IBM.