Brad Sanderson, senior strategic advisor, head of health outcomes at CRF Health, said the pharmaceutical industry has increased its use of electronic patient reported outcomes (ePROs) in oncology studies over the last 10 years – especially for quality of life and symptom endpoints.
This trend will continue, he told us, with “significant growth” of ePRO in oncology expected as both big pharma and smaller companies have started adopting the enabling technologies.
Within clinical trials, Sanderson said the deployment of ePRO instruments helps reduce site and patient burden while increasing compliance and improving data quality.
“The ability to automate the site visit flow of questionnaires means that the right questionnaire is collected at the right time and the set-up requirement for sites is reduced,” he explained.
Sites also can capture data with handheld devices at a patient’s home, which becomes especially important if patients are too unwell to visit study sites. This also helps ensure that high compliance rates are sustained.
“Where patients are too sick to complete a specific visit, flexible visit scheduling allows sites to stay compliant with the study protocol,” said Sanderson. “Endpoints such as quality of life, symptoms, pain, dosing and concomitant medication use can be tracked remotely and in real-time, and this ensures that sites focus on patients that need attention.”
As to be expected, many of these site benefits are the same for patients. Specifically, flexible visit scheduling allows sites to extend data-entry windows and have the patient visit the site when they feel able. As Sanderson explained, mixed modes for data collection can reduce the need for site visits while maintaining a high level of compliance.
“Even with alternative data capture methods, patients may get to the stage where they are unable to complete PROs or eDiaries without assistance and this is where diaries or tablets can be programmed to include a caregiver role,” he added.
“Oncology patients are regularly subjected to extensive testing procedures inside a clinical trial, however, they rarely have a large capacity for extensive engagement,” Sanderson explained.
Additionally, he noted that long time periods devoted to questionnaire completion should be avoided, as the process can become burdensome to patients and potentially compromises data quality.
“Less is more in the context of data collection inside oncology trials,” Sanderson said, “and there is a strong need for sponsors to work hard on selecting the right PRO’s upfront to ensure that a tight batch of questionnaires is targeted, deployed and collected.”
Electronic consent
As it pertains to patient recruitment, Sanderson said the biggest opportunity within the clinical trial environment is the advent of electronic consent (eConsent).
“eConsent provides a huge opportunity to improve patient comprehension of study procedures before embarking on a clinical study which may reduce the risk of drop out,” he explained.
Additionally, eConsent provides a quality assurance (QA) trail to support good clinical practice (GCP) regulatory requirements.
“Furthermore, specifically relevant to oncology trials, is the flexibility with which eConsent can manage the completion of multiple consent forms with relative ease,” explained Sanderson. This could include biopsy or imaging consent forms, which he noted if not appropriately signed, may result in a sponsor not being able to use the data as planned.