Solutions Driving Efficiency in Clinical Trials

December 12, 2016
Cornelia Wels-Maug

,
Le Vin Chin

The advancement of technology has allowed for new solutions to become available in all areas of clinical trials. Patient Recruitment Systems are no exception as they can be used to improve the trial process by optimizing protocols, selecting high potential sites and enabling more studies.

As technology advances, new solutions in all areas of clinical trials, recruitment and retention evolve to make these processes more efficient. As other solutions look to big data, so does Clinerion’s Patient Recruitment System (PRS) solution, which queries the full electronic health record databases at hospitals connected to PRS. Clinerion’s platform enables real-time patient identification for example, last minute entrants to an ER). In results to-date, PRS finds an average of 10 to 30 times more patients and identifies them faster compared to manual screening. A query via PRS produces results in minutes, compared to the weeks, or months, required to collect data from the same hospitals.

Like other solutions for patient recruitment, PRS can also be used to accelerate the clinical trial process by

  • Optimizing protocols: By optimizing the number of potential patients for a protocol in PRS’s Protocol Designer tool, the feasibility of a study can be evaluated.

  • Selecting high-potential trials sites: By running a query in PRS's Site Finder tool to determine the location distribution of potentially eligible patients – and can then decide which hospital to approach to become a trial site.

  • Enabling more studies to be conducted: Due to more efficient processes and a higher number of patients recruited, trial sites can run more studies and increase their reputation for high performance and innovation.

PRS works by screening the medical records databases of connected hospitals, spanning many institutions in diverse geographies and the millions of candidate patients in those institutions. Hospitals electing to join install a PRS server within their own IT infrastructure, onto which they load pseudonymized, enriched and indexed patient data. Although each hospital’s database may have a different structure and may be supplied by a different systems supplier, the patient records from different sources are made interoperable by a set of mapping and semantic methodologies. The PRS cloud then delivers queries to these “federated” installed servers, and the results – the count of patients who fit the criteria – are returned for aggregation in the cloud.

Once installed, PRS is controlled by a site’s own IT department. To ensure privacy and security of patient data, the latter is pseudonymized and patient IDs can only be re-identified by authorized personnel on a hospital’s premises via the PRS Patient Finder tool. Each site controls the pseudonymization to ensure that no un-authorized, re-identification of patient IDs can be performed. As soon as a patient who matches eligibility criteria is identified, the respective study team will be notified by SMS text, Instant Messaging or email.

Istanbul University’s Cardiology Institute is a user of PRS. It has 113 beds and 33 physicians treating 75,840 patients per year. One user at the institute said, “Before PRS, we were waiting for resident doctors to send us new patients. Each day we had to remind and ask them about new candidates. It was a time-consuming process. They were busy with their clinical responsibilities so we caused them additional work.”

Previously, the staff would try to validate potential candidates within the hospital information system, but by only using one or two criteria, again more of the workload fell to the principal investigator to identify potential patients. By using the PRS, the principal investigator workload was reduced. “Before PRS, our study team recruited 15 patients in six months,” the Cardiology Institute respondent continued. “With PRS they enrolled 36 additional patients, which took less than two months and solely from screening only 15% of PRS’s patient list.”

Earlier this year, The International Clinical Trial Center Network adopted Clinerion’s PRS system. Clinerion most recently launched its Patient Finder Tool into the new area of market access for precision medicine and is working with eClinicalHealth to validate its hospital system in Turkey to extend its patient recruitment and retention abilities in the area of patient reimbursement.

By Cornelia Wels-Maug, Principal Healthcare Analyst at Creative Intellect Consulting, and Le Vin Chin, Head of Marketing and Communications, Clinerion Ltd.