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Industry now leveraging reporting system to empower patients and improve research.
In the new paradigm of patient-centered research and care, the inclusion of patient reported outcomes (PROs) are central to evaluating new drugs, particularly in fields like oncology, where cancer patients’ diseases can be especially debilitating and affect their overall quality of life and life expectancy. Historically, trial participants battling cancer have also been burdened with reporting important toxicities and side effects directly to their providers. Incomplete reporting, patient bias and inadequate trial investigator communication can result in lack of information that could potentially improve drug labeling claims and inform researchers and regulators in the development and approval of new drugs,
To address these challenges, sponsors are now leveraging ePROs to create the opportunity to empower patients to self-report symptoms without bias. These tools can reduce cancer patient reporting burden and reluctance while capturing the best information on subjective symptoms. ePRO allows patients to easily report their conditions, symptoms, side effects, drug timing, directly from electronic devices.
The standard paper-based practices that clinicians use to report patient toxicity symptoms and side effects in cancer trials are, by today’s standards, complex and inefficient. Interest in collecting PROs in trials has been growing over the last several years amongst clinicians and patients as well as regulators. However, the concern around potentially incomplete and inconsistent communication between patients and providers remains an obstacle to implementation. From navigating a multitude of chemotherapy and other appointments to the sheer impact of the disease on everyday quality of life, the burden on cancer patients to report outcomes consistently and regularly through traditional methods is especially high. At the same time, failing to collect that data could hurt the completeness of the study that will be essential for regulatory approval down the line. Practitioners need entirely accurate and well-encompassed PRO data to make trial management decisions and compile a submission. As the clinical trial space becomes more digitally driven, ePROs are a logical progression that answers these challenges. ePROs can be completed from the convenience of the patient’s home and drive compliance through the use of automated reporting windows, and reminder alerts. Information from ePROs is immediately accessible to Investigators, easily stored and transmitted, and does not require research personnel to manually enter data into a database.
PROs allow the possibility for patients to share with ease their symptoms, side effects, drug timing, etc., directly from technologies, such as smartphones and wearable devices. With patient centricity being at the core of most clinical trial designs today, ePROs ensure that participants have the best experience while providing clinicians visibility into the patient experience in order to deliver optimal care.This is because clinicians can directly monitor variables such as their patients’ tolerance, response, and symptoms, related to the disease itself or treatment effects. Capturing insights electronically enhances this process by enabling more frequent and holistic data reviews which can contribute to better clinical efficacy and improved outcomes while empowering patients. For example, the use of ePROs in studies of patients with advanced cancer can potentially contribute to reduced emergency department visits and improved one-year survival compared with traditional clinical care.
It is critical to continue to take advantage of technologies that promote quality care for cancer patients. ePROs offer a mutually beneficial solution for patients and providers for capturing the patient experience in a consistent, well-rounded, and simple way. Simultaneously, continuing to enable patients to self-report side effects and symptoms will help clinicians to holistically capture and report toxicities. The result will be better safety information about new therapies and enhanced future drug development overall. Looking forward, ePROs can become a cornerstone of evaluating cancer treatment. This technology will be essential to improve the experience of patients who do the important work of giving their time to clinical research to improve many lives beyond their own.
Melissa Mooney, Director, eCOA Solutions Engineering, IQVIA