Hospitals open records to boost trial enrolment

Finding willing and eligible patients to participate in clinical trials is a major hurdle in drug development. Now, a consortium of 13 New York area hospitals and 5 major pharma companies has put together a new way to solve the problem. Called PACeR (Partnership to Advance Clinical Electronic Research), the programme will provide bare-bones, ‘de-identified’ medical records so that companies — for a fee — can search for eligible clinical-trial participants.

According to Bloomberg, which reported the effort today, the programme will begin testing this month and is projected to earn US$75 million a year for participating hospitals. The programme’s whitepaper details a massive undertaking that includes efforts to standardize the vocabulary used in medical records, improve patient education, and expand the use of the PACeR model beyond trials and into other fields such as epidemiology and comparative-effectiveness research.

But of course there are those pesky privacy concerns. The hospitals will not include identifying information, such as names and addresses, in their databases. And once a company has its list of potential enrolees, the hospitals will then contact the patients’ doctors rather than directly approaching patients. Given the debate about what it takes to truly de-identify medical records — especially as genetic sequencing moves into the clinic — it’s easy to imagine that some sceptics will remain.

Still, there is no denying that researchers need new ways to reach out to potential clinical trial participants. Ken Getz of the Tufts Center for the Study of Drug Development in Boston has determined that 90% or more of clinical trials are extended by at least six weeks to account for delays in patient accrual. Bloomberg cites a figure from Deloitte Consulting, which calculated that it costs $1 million for each day of delay during a phase III trial. It’s a problem that may be exacerbated by the increased focus on ‘personalized’ therapies, which can shrink the pool of eligible patients (although it can also decrease the size of the trial needed to show efficacy). In short: look for more of these efforts, and soon.

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