Although patients are becoming increasingly informed and empowered to take a proactive role in clinical research, they are still more likely to participate in a trial if their doctor suggests it. That’s the principal message from an article in February’s issue of CenterWatch Monthly. Yet doctors are referring only 0.2% of their patients to clinical trials in the United States and Europe.
A few enterprising companies have taken a new approach to clinical trial recruitment, accessing the electronic medical records (EMR) that physicians hold on behalf of their patients. An EMR is an electronic version of a patient’s medical history, and it can be a highly effective tool for identifying a patient who meets the strict eligibility criteria for a typical research study. A recruiter can then directly contact an eligible patient’s doctor to inform them of a trial.
ePatientFinder is one such company who mine EMR data and then inform physicians who are signed up to the service if they find a potentially eligible patient. They have reported that 85% of patients are interested in a trial and 78% are accepted onto it, after being informed by their doctor.
In another example, the Salford Lung Study, conducted in the north-west of England, showed how this approach can work well for an individual trial. Sponsored by GSK, patients were identified and recruited by a team of research nurses brought in to comb through databases kept by primary care practices in the region. Researchers also used EMRs as a tool throughout the study to record and monitor patients’ health. A total of 2,802 patients were enrolled in this way.
Widespread use of EMRs in clinical trial recruitment has been held back by the challenges of accessing large volumes of patient data, while also complying with data protection regulations. A recent Consero Group survey found that 54% of general counsel in the healthcare industry were concerned about meeting HIPAA/HITECH compliance requirements. The Health Information Technology for Economic and Clinical Health Act (HITECH) was created, in part, to allow the adoption of EMRs.
EMRs can help connect physicians with potentially eligible patients who they are open to referring, with the information and support they need to make the referral. But they don’t solve all recruitment-related issues, as a physician’s duty of care towards their patients does not stop when they are referred to a trial site.
In a recent Tufts survey, nearly 30% of physicians reported not receiving follow-up information from study sites following a referral. A higher percentage never received their patients’ clinical trial results. It is crucial to keep doctors engaged in the process if you hope they will refer again in the future. At the same time, it is important that patients are engaged as much as possible in clinical trials.
EMRs may help to alleviate recruitment pressures further in the future if data concerns can be overcome. But their adoption should not be at the expense of patient and physician engagement.
By Joanna Blackburn
Image by NEC Corporation of America on Flickr