As clinical research protocols increase in complexity and the list of inclusion and exclusion criteria a patient must meet to qualify for clinical research studies grows, many research sites are faced with participant recruitment challenges. The Medical University of South Carolina is one of them.

THE PROBLEM

Those stricter criteria mean more personnel time is dedicated to chart review and more charts must be reviewed before finding a patient that qualifies to contact for screening for a clinical trial.

PROPOSAL

The Medical University of South Carolina turned to TriNetX, which offers an electronic health record participant cohort assessment tool that allows research staff to harness the power of data within the EHR to hone in on a more focused count of potential participants who may meet study criteria, the hospital explained.

MARKETPLACE

It can be difficult to din technology vendors that specialize in EHR-linked participant cohort assessment tools for clinical research and trials. Two similar vendors include BBK Worldwide and Ripple. However, there are many vendors of clinical trials IT, including Castor EDC, ClinCapture, Dacima Clinical Suite, Ennov CTMS, iMedNet EDC, Longboat, Medrio and Smartsheet.

MEETING THE CHALLENGE

"By offering a simple, straightforward user interface, TriNetX enables clinical research staff, who may not be trained in informatics or programming, broader access to self-service query tools that allow researchers and their teams the ability to perform patient cohort assessments on data available within the EHR in a de-identified manner," said Signe Denmark, associate director of research opportunities and collaborations at the office of clinical research at the Medical University of South Carolina.

This allows researchers to make more informed decisions about clinical research study design or feasibility decisions in compliance with data protection standards.

"Once a robust query is built and an investigator is approved by an Institutional Review Board to leverage an identified patient list for recruitment, the TriNetX query can be shared with a Medical University of South Carolina honest broker," Denmark explained. "The hospital honest broker is approved to take the de-identified TriNetX list and securely provide a recruitment list to the study team."

Honest broker resources are limited and the efficiencies that the technology offers allows the hospital to maximize and further extend those limited personnel resources, she added.

RESULTS

An example of a study in which the Medical University of South Carolina achieved recruitment success by leveraging the technology was with an industry-sponsored hyperlipidemia study that was a zero enroller at the hospital's site for two months prior to leveraging a TriNetX query to identify patients for screening.

"The hospital was able to screen six patients and ultimately enroll four off of the first TriNetX recruitment list generated by hospital honest brokers," Denmark said. "This allowed our site to transition from changing our status as a 'zero enrolling site' after four months to a successful recruiting site."

"This allowed our site to transition from changing our status as a 'zero enrolling site' after four months to a successful recruiting site."

Signe Denmark, Medical University of South Carolina

The Medical University of South Carolina's "site scorecard enrollment factor" (provided to the hospital by a contract research organization partner) after those four patients were enrolled jumped from 0 percent to 336 percent, or 236 percent better than other sites running the same study.

"The MUSC research team continues to utilize the TriNetX query for MUSC honest brokers to translate into identified patient lists for the study team to utilize to recruit participants," she said. "The study now has a total of six patients enrolled; 10 have been screened, four patients did not end up meeting inclusion criteria and are considered screen failures."

The hospital site's current "site scorecard enrollment factor" is 136 percent for this study, so it remains 36 percent ahead of other sites running this same trial in terms of enrollment.

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com