Although paper diaries may be familiar to many sponsors and clinical trial sites, traditional patient journals have the ability to invalidate otherwise reliable and valid clinical trial assessments. That unfortunate scenario can contribute to the ruin of multi-million-dollar clinical trials, depending on primary and secondary objectives as outlined in clinical protocols, which are the main objectives for clinical assessments of safety, efficacy and efficaciousness (Gupta, 2015).
How controversial are paper diaries? Many professionals in the field may note that paper diaries are often:
- Completed or filled out the night before, or in parking lots prior to patient site visits.
- Have the capacity to become large piles of less than contemporaneous data housed in costly storage for a regulated number of years.
- Time consuming and costly when sites and monitors attempt to decipher, enter, source data review and verify paper entries.
Within the industry, it is widely accepted that paper diaries are a relic, but the reality is that paper diaries continue to be widely used despite industry and regulatory encouragement to utilize electronic means; so the question is how can electronic patient reported outcome (ePRO) technology shape the future of clinical research?
BYOD (Bring Your Own Device) & ePRO Solutions
In a clinical setting, ePRO has historically been the catchall term for data captured directly from patients through digital tools, such as smart phones, desktop PCs, laptops or tablets. More recently, the industry has used the term electronic clinical outcome assessment (eCOA) to define the broader set of outcomes assessments captured direct from patients. Operated by patients, those devices can yield information on disease status, treatment compliance and other health data, thereby allowing researchers to quickly qualify and quantify patient outcomes and/or satisfaction. The most common method for utilizing these tools is to provision devices for every participating patient, which can be quite costly. Designed and validated for use in personal devices, ePRO technology can be bundled directly into electronic data capture (EDC) systems, such as TrialMaster®. This process can make patient data entry seamless and comfortable to administer for all age groups because patients are familiar with their own devices — hence the term: BYOD.
When data is sent directly from a patient’s PC/handheld device, or from a tablet operated on-site by the clinical research coordinator (CRC), the ease with which patients may participate directly in a clinical trial is perhaps the key to successful recruitment, retention, and at the end of the day, the fastest way to submission and approval.
- Tracks subject satisfaction and participation for improved recruitment and retention.
- Improves patient safety by ensuring real-time reporting of adverse and serious adverse events.
- Supports BYOD strategies and allows patients to feel confident and comfortable with the use of technology.
- Increases patient medication compliance through ongoing notifications or programmed alerts.
- Increases pain-scoring compliance with reminders and alerts.
- Reduces cost of obtaining and collecting devices.
- Decreases queries and data-entry time for CRCs.
- Decreases time for on-site monitoring source data review (SDV).
- Facilitates a higher level of data accuracy.
- Reduces the amount of fake or invented data. (Gupta, 2015).
- Allows researchers the ability to quantify and qualify patient disease activity and outcomes through biostatistical analyses in real time. https://www.fda.gov/Drugs/NewsEvents/ucm607276.htm
- Enhances the ability for patients to report on the status of their own health that comes without interpretation or bias. https://www.ispor.org/.../excerpt-ispor-epro-systems-validation-task-force-report.pdf
Patient reported outcomes via technological interface have been getting the attention of regulatory agencies for some time. However, the need to regulate and advocate for the use of ePRO in clinical trials has become a priority for regulators. In fact, during a recent public FDA panel discussion, agency panelists asserted that the FDA aims to ensure that a patient-centric approach to drug development becomes a standard practice in clinical trials. The way forward is to ensure the accuracy and reliability of data (FDA.gov, 2018). One such measure focuses on methods to capture data related to daily activities and quality of life due to disease progression. This objective highlights the importance and timeliness of ensuring that real-time data driven analytics are the driving forces of clinical trials.
What Does the Future Hold?
With the industry movement towards patient centricity and patient advocacy, along with the growing acceptance of BYOD, it is likely that the role of ePRO within all trials will continue to expand and evolve. The increase of late-stage studies along with new paradigms, such as virtual trials and direct-to-patient studies, will further accelerate this expansion. And finally, the burgeoning industry adoption of mobile health and wearable technologies will complement and sustain the shift towards patient-centric data capture and patient-reported outcomes.
About the Author
Bridget Tyrka is a project manager at OmniComm Systems, Inc. She has more than eight years of clinical trial experience. In 2012, Bridget earned a Master of Science degree in Clinical Research Administration. She entered the industry as a clinical research coordinator (CRC) and obtained her CRC Certification (CCRC) from ACRP. She quickly moved to a senior role, overseeing hospital-based clinical trials with focuses on cardiovascular, anesthesiology and OB/GYN trials. Bridget made the switch to Project Management with OmniComm Systems three years ago and obtained her certification as a Project Management Professional (PMP) in 2018. She is currently working on a doctorate in Healthcare Administration and plans on publishing her dissertation on hospital quality in early 2020. Through Bridget’s combined education and career experience, she has a unique and broad vision of the clinical research and healthcare industry. She believes that the path to becoming learning health organizations will depend upon data-driven analytics and the understanding of patient perceptions of health and clinical outcomes (AHRQ.gov, 2018).