In recent years, efficient patient recruitment has become increasingly crucial to clinical trials. When PPD acquired Acurian in 2014, it confirmed how central patient recruitment services have become to clinical trial planning. In 2015, Clinovo changed the landscape of Electronic Data Capture (EDC) by releasing an open-source version of ClinCapture, its validated, cloud-based EDC system for managing electronic case report forms. By offering a self-service portal where clients can build, deploy and produce their studies for free, Clinovo made EDC accessible to all organizations running clinical trials.
Now, the latest advances in patient recruitment are at Clinerion, a Swiss-based global software and services company specializing in patient recruitment informatics. First launched in Europe in 2014, Clinerion’s Patient Recruitment System (PRS) is available in North America as well.
Clinerion’s PRS identifies suitable candidates for a particular clinical trial via automated, real-time screening of electronic health records (EHRs). The result: 10 to 30 times more patients are found with PRS as compared to manual screening, and results take minutes instead of weeks or months. With such a large pool of suitable candidates, more patients are ultimately enrolled, boosting the trial’s effectiveness and giving trial site hospitals access to cutting-edge research and medicines.
When screening EHRs, Clinerion’s system looks at everything from coded information and numerical data to free text, such as narratives and reports.
A hybrid system, it includes both cloud and physical servers. Equipped with an internal and external interface, PRS runs inside a hospital’s infrastructure. Patient data is de-identified before query and never transferred outside the hospital, in compliance with HIPAA and FDA standards.
Clinerion Marketing Manager Le Vin Chin explained, “Users at pharmaceutical sponsors see only aggregate numbers, but eligible staff at the trial sites and hospitals, such as primary investigators and study nurses, can use PRS to pinpoint suitable trial candidates at their site.”
PRS is especially valuable when enrolling patients in rare disease clinical trials, by culling single patients from millions of records in minutes.
The complete PRS system is actually made up of three components, recently renamed: Protocol Designer, Site Finder and Patient Finder.
In terms of cost, Chin said, “Hospitals pay a shared implantation cost, and the remaining cost is typically carried by the sponsor. Academic studies are possible at any time and at no cost, of course.”
Chin recalled when the world’s largest biotech company began using PRS for an ongoing dyslipidemia clinical trial in late 2014 in Istanbul. The principal investigator hoped to expand the number of patients enrolled and make her site one of the best performing. “Three months into the trial,” Chin said, “the study team had enrolled about one third of the required number of patients. After activating PRS, the PI reached the remaining 64% of her commitment in only 6 weeks. The recruiting process closed early, and was achieved by only validating 15% of the patient candidates identified by PRS.”
One of the study team members reported, “Normally it takes hours to screen the archives for eligible patients. However, with this tool we spent much less time finding patients and consequently had more time for other tasks. This had a positive impact on our study quality.”
Clearly, tools like PRS can dramatically change how clinical trials are conducted from now on. Chin stated, “In principle, Clinerion PRS makes instantaneous feasibility possible, allowing the user to go from protocol to recruitment in one step. It integrates EHRs and makes them interoperable throughout hospitals, research sites and countries, with the end game that you could cover feasibility of a study based on the aggregate data.”
Lisa Chontos is a freelance medical writer with 15 years of experience writing for hospitals, biotech firms, pharmaceutical companies and publications like CenterWatch. You can contact her at email@example.com.
This article was reprinted from Volume 20, Issue 04, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »