Oncology ePRO eCOA

Agile Lunexis™ ePRO+ Methodology: Eliminating Barriers to Cancer Research

In oncology research, patient-reported outcomes (PRO) such as patient-reported information about symptoms, treatment side effects, functional outcomes, emotional or cognitive functioning, and health-related quality of life (HRQOL) have historically been collected on paper.

With the growth in clinical research digital technologies, electronic PRO (ePRO) is rapidly becoming the standard across the clinical research industry because of increased ease of use, better data quality, and real-time access to site and patient data for remote monitors and sponsors.

You need streamlined, intuitive ePRO and ClinRO technology that expedites oncology workflows, lessens the burden on patients, and saves caregivers time. This blog explains how Clinical Ink’s robust, configurable platform connects sponsors, CROs, sites, and patients, fostering better cancer research and a higher standard of care.

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What Makes ePRO Valuable for PATIENTS in Oncology Trials?

1. Oncology patients have lots to report
What do surgery, chemotherapy, radiation, and hormonal therapy have in common? Side effects. Add in the symptoms of the cancer itself, and patients have a lot to talk about. While survival remains the most frequently used measure of clinical benefit for most cancer treatments, PRO measures convey important information about the overall patient burden, effectiveness of treatments, and quality of life.

2. Regulatory agencies support bringing the patient's perspective into cancer decision-making
As far back as 2015, the FDA conducted 24 disease-specific Patient-Focused Drug Development (PFDD) meetings to gather patients’ perspectives — including those from oncology patients. Since then, the agency has continued to promote efforts to gather information directly from the patient, especially through cost-effective and efficient means like ePRO.

3. ePRO offers a more patient-centric experience
Unlike paper-based PRO measurements, ePRO facilitates more quality time between patients and health care professionals by easing both site and patient burdens. Easy-to-use apps enable patients to enter information without cumbersome selections and workflows, either in the clinic or at home. This is great for oncology patients who already face a high burden of disease and associated treatment regimens.

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4. Greater engagement puts patients at ease
The ePRO solution offered by Clinical Ink provides a mobile app that guides the patient through required diary and questionnaire activities using conditional reminders and alerts, daily schedules, and task trackers. It also offers resources like content libraries of useful study and indication related information, clinic contact information, and visit-by-visit preparation instructions.

5. Fewer visits mean broader access
Clinical trial participation can be cumbersome and expensive for patients who don’t live near major medical centers. ePRO technology may enable access to more oncology patients from a more diverse cohort in rural, remote, or international locations.

6. Better monitoring can lead to improved outcomes
Unlike paper-based methods, ePRO tools enable real-time monitoring, allowing teams to respond more quickly and provide better care sooner. Research evidence suggests oncology patient outcomes may improve due to more timely site notifications of worsening symptoms, allowing physicians to take appropriate action.

7. Mixed modalities lighten the load
Lunexis ePRO+ was developed from the ground up with the convenience of cancer patients and sites in mind. The single platform built for mixed modalities allows patients and sites to switch back and forth among phone, web, or tablet — at virtual or physical sites — as desired. This capability, along with Wi-Fi and cellular connectivity, allows for highly flexible delivery of care that connects stakeholders whenever and wherever needed.

What makes ePRO Especially Valuable for SITES in Oncology Trials?

1. During site visits, ePRO frees up staff
In oncology studies, ePRO is typically collected during site visits. Our versatile ePRO+ solution relieves busy sites by eliminating redundant sign-in and administrative tasks of assisting patients and caregivers to complete necessary information. Lunexis ePRO+ also connects sponsors with more complete data. Tablets walk the patients through the questionnaire, lessening site burden and increasing patient centricity while streamlining electronic data capture for oncology questionnaires. Clinical Ink’s simple workflow and interface eliminate the need for any site staff intervention.

2. Better patient engagement leads to better protocol compliance
Automated reminders and notifications to the patients of tasks due improve patient adherence while saving the research coordinator’s time. Automated email notifications to the coordinator draw attention to any compliance issues early so they can be addressed. Better compliance means more complete, accurate data for more reliable results.

3. ePRO leads to improved data quality
Paper-based PRO necessitates inefficient, manual data entry and duplicate storage. These data are often incomplete, nearly impossible to validate for timelines, and do not readily support audit trails. ePRO:

  • Eliminates the need for data transcription and its potential risk of error
  • Streamlines and automates data entry and checking processes
  • Ensures timely and complete data entry with full attribution
  • Enables health care professionals to focus on evaluating responses rather than entering them

4. Real-time access to data improves safety and compliance
With Clinical Ink, data is immediately available through the portal for monitoring and reporting. This real-time monitoring is especially critical with oncology patients when quick medical response is warranted. ePRO also allows complete visibility of patient status. Activity is tracked at the study, patient, and task level in real time, so intervention is still possible.

What makes ePRO Especially Valuable for SPONSORS and CROS in Oncology Trials?

1. Agile ePRO deployment saves time and resources
Sponsors and CROs seeking ways to speed study startup can benefit from ePRO technology. Not only is development faster than paper-based processes, but ePRO allows sponsors and CROs to receive compliance, HRQOL, and monitoring results in an expedited fashion.

Traditional approaches for building ePRO tools require a highly iterative process, though — a waterfall approach that not only wastes time but is focused on functional requirements rather than the patient experience. In contrast, Clinical Ink employs an agile approach focused on improving user experiences for patients, sites, and sponsors/CROs. With our ePRO+ launch, our builds are 3x faster.

2. Clinical Ink manages the electronic use review and verification process for copywritten oncology questionnaires –– and saves them in a library
We also accommodate saving program-specific diaries and questionnaires in sponsor-specific and/or shared libraries. A user can configure and test a questionnaire once and reuse it in future studies.

Stronger Connections, Better Research, and Greater Care in Oncology Trials

By enabling an agile ePRO study design, Clinical Ink builds connections among sponsors, CROs, patients, and sites. This improved oncology trial design, deployment, and monitoring process results in a better experience for all. Rather than focusing on only conceptual functional requirements, oncology project teams work with ePRO prototypes, testing questionnaires and workflows just as their patients would experience them.

This agile ePRO design means that oncology studies can start faster while lessening the burden faced by sites and, especially, patients. Our fit-for-purpose Lunexis™ platform was developed with the convenience of cancer patients and sites in mind. You benefit from a single platform built for mixed modalities: Patients and sites can switch back and forth among phone, web, or tablet — at virtual visits or physical sites — as desired. This capability, along with Wi-Fi and cellular connectivity, allows for highly flexible delivery of care that connects stakeholders whenever and wherever needed. Your clean, integrated data speeds you along the path to more confident decisions.

For stronger connections, better research, and greater care, eliminate the barriers to cancer research with Lunexis.

Topics: Oncology, ePRO, eCOA

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