Patient recruitment is often a major challenge in drug development due to the misalignment between patient definition criteria in the protocol and the real clinical and laboratory profile of patients.
To address this challenge, contract research organizations (CROs) have been adopting the use of electronic medical records to improve the process.
“Clinical and laboratory data from EMRs can be used to provide important information to build protocols, identify investigators and patients and to execute a trial with a project plan that reflects daily medical care,” Lars Olof Eriksson, EVP Site and Patient Recruitment at Icon, told Outsourcing-Pharma.com.
As Erkisson explained, this approach has the potential to result in more realistic and reliable plans “where quality, time, resources and finances are predictable with results accurately reflecting the disease category being studied.”
To leverage this potential, Icon recently adopted the use of TriNetX, a research network and technology platform, which connects the CRO the electronic medical records (EMRs) of 57m patients across the globe.
EMRs offer many advantages to study teams
For one, EMRs can support study design and protocol writing: “Patient information in EMR systems provides aggregated information on clinical and laboratory profiles of the targeted patient group,” Eriksson explained.
Virtual parameter modifications on demographic, diagnostic, and laboratory variables, including age, disease severity, liver, kidney, and metabolic functions, can be applied to run “what if” scenarios on patient numbers.
EMRs can also support investigator identification and facilitate recruitment of patients.
Specifically, the systems can generate potential patient lists with test data that matches the protocol criteria in addition to the information on the treating physicians.
“Such information can be overlapped with information on certified investigators and be instrumental in the final site selection,” said Eriksson. “After investigator selection, the generated list of potential ‘matched’ patients can be used by the institution as an important tool to plan and target recruitment of patients.”
Investigators can also use EMRs to alert treating physicians to refer patients to investigators within the same or affiliated health care systems.
“Qualifying ‘rules’ can be configured in the EMR system so that during the course of a patient/physician visit, the physician is presented with a message that the patient may be a candidate for an ongoing trial,” explained Eriksson.
For adaptive design trials in particular, Eriksson said advances in computational technology, such as the application of EMRs, are essential.
“The challenges for adaptive clinical trials are statistically more complex designs and enhanced logistical requirements. Patient recruitment must be limited in time and control of subject flows throughout the study kept tight,” he said.
“By utilizing the power of EMRs, the timeframes for patient recruitment into a study can be limited making the interim analyses more feasible.”
Additionally, EMRs can facilitate timely data collection and, ultimately, an overall improved trial conduct.
“With these prerequisites, the new approaches result in trial designs with increased safety and efficacy, significantly reduced drug development times and costs as well as fewer people exposed to experimental treatments,” said Eriksson.