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There has been of lot of buzz around the integration of clinical research (especially electronic data capture (EDC)) with healthcare (electronic health records (EHRs) in particular) over the last few months. Therefore, it is a good time to review the current status, to discuss what the major hurdles for real-life implementation are, and to look at the regulatory issues, especially regarding submissions to the FDA.
CURRENT STATUS
Clinical investigators don’t have an easy life. They often need to enter the same data twice, once in the hospital information system (HIS) and then again in the clinical EDC system. Often, this also means that they need to work with different computers, one for the HIS and one for the EDC system. In the best case scenario, they can copy and paste information from one application into the other.
Ideally, hospital information systems should keep, or be able to produce, EHRs of the patients that are being treated. These can then be used later by other caretakers in other hospitals or by the patient’s own general practicioner. Many countries in the world currently have programmes to develop standardised EHRs, but unfortunately, each country has its own strategy and technical requirements, resulting in a multitude of formats and systems. This is especially a problem in Europe, where more and more people use their right to free movement of labour, and move to another country regularly (1).
With the rise of EHRs, a number of projects surrounding the integration of EDC and EHRs have seen the light in the last few years. Almost all of them have been initiated by Landen Bain, CDISC’s ‘liason to healthcare’. The first results are now being demonstrated and the first real-life system has now gone into production (2).
The earliest, and best known project is still the IHE RFD profile (3). IHE stands for ‘integrating the healthcare industry’ and is an initiative of healthcare IT professionals, mostly from vendor companies; clinical research is only a small part of the initiative. IHE publishes so-called ‘profiles’ which can be seen as a project description. One of these is the ‘retrieve for data capture’ (RFD) profile. It describes the criteria and proposes technologies for the retrieval of information from an EHR to prefill an electronic case report form (eCRF) with data from the EHR. The profile only describes ‘how it can be done’. For example, the original RFD profile assumed XForms technology for the EDC system, but in real life, this will of course not always be the case. |
