For improved clinical research, investigators and researchers may need to capture continuous data. Advances in technology make this possible by digitizing PROMs into ePROMs, allowing the patient to maintain an electronic diary, using wearable devices or sensors or even via simple surveys.
MANASSAS, Va. (PRWEB)
July 12, 2022
A survey of recent research indicates that electronic Patient-Reported Outcome Measures (ePROMs) offer numerous advantages over traditional approaches to clinical trials and practice, including better patient acceptance and data quality, faster completion times, and improvements in both clinical decision-making and symptom management.(1) “There are also,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, “some reported objections to heavily ePROM-based research having to do with privacy protection, initial financial investment, data quality/reliability, and the exclusion of certain participants due to a so-called ‘digital divide.’ However, the combination of a platform approach and reliance on available digital technology is rapidly rendering those objections moot.”
“The solution is not just having technical features but making sure those features are configurable in a way that matches the human and cultural aspects – the social determinants of health.” Dr. Harsha Rajasimha, Founder CEO of Jeeva Informatics
Traditionally, says Dr. Rajasimha, patients and clinical trial subjects make periodic in-person visits to the facilities responsible for their study or treatment, during which they are assessed by healthcare professionals. The answers to those questions are recorded and become the study’s primary patient database. This episodic question-and-answer format, says Dr. Rajasimha, fails to include continuous patient-reported information on behavioral issues, side effects, mental health considerations, patient symptoms, diet, and lifestyle. “We need to know these things,” says Dr. Rajasimha. “Patient-related outcome measures contain crucial data that matter greatly to the clinical researchers, and of which only patients can inform them.”
Vital as this information is, PROMs, cautions Dr. Rajasimha, are not a replacement for clinical assessments, but a supplement to it. For improved clinical research, investigators and researchers may need to capture continuous data. Advances in technology make this possible by digitizing PROMs into ePROMs, allowing the patient to maintain an electronic diary, using wearable devices or sensors or even via simple surveys.
Concerns have been raised about ePROM data, notes Dr. Rajasimha, in three areas. One is that participants not comfortable with use of technology involved might end up reporting incorrect or inaccurate data. A second is that a “digital divide” exists between those who are accustomed to digital technology and those who are not, and that a heavy reliance of ePROM data might disproportionately exclude middle- and lower-income participants from a given study. Finally, the possibility has been raised that clinical care providers and trial sponsors could face unmanageably high startup and equipment costs in converting to an ePROM-based data collection system.
The future is here
These objections, says Dr. Rajasimha, are essentially nullified by the soon-to-be prevailing model of digital patient data gathering, in which participants communicate through their own digital devices with a cloud-based centralized service platform designed to accommodate both the participants’ and researchers’ needs. As to the existence of an exclusionary “digital divide,” Dr. Rajasimha notes that as of 2022 the population of the United States is estimated to be slightly over 332 million people(2), nearly 302 millions of whom, i.e., 90%, are smartphone users.(3) “The infrastructure for widespread ePROM-based research,” he says, “exists and can be made more accessible by the use of BYOD—bring your own device technology architecture.”
For this infrastructure to yield optimum results, says Dr. Rajasimha, there must be efficient patient screening, enrollment, and e-consent communications, along with the flexibility needed to take into consideration cultural, religious, and other social determinants of health of a large and diverse population. The biggest issue, he says, is making sure patients respond to a given clinical trial’s parameters by educating them as to what those parameters are.
The overall solution, says Dr. Rajasimha, is to adopt a modular digital platform for improved clinical research. “Rather than look at ePROMs, eConsent, televisits or video visits, and electronic data capture as separate issues in silos,” he says, “researchers need to think about simplifying and bringing all these functions seamlessly into a single login on one platform, in a way that minimizes the burden on researchers and accommodating the personalized aspects of the participants profiles. The platform approach is the way to achieve the best results with patient-reported outcomes in the context of a full end-to-end clinical trial operation.”
About Jeeva Informatics
The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/.
1. Meirte, Jill, et al. “Benefits and Disadvantages of Electronic Patient-Reported Outcome Measures: Systematic Review.” JMIR Perioperative Medicine, JMIR Publications Inc., periop.jmir.org/2020/1/e15588/.
2. “U.S. Population Estimated at 332,403,650 on Jan. 1, 2022.” U.S. Department of Commerce, 6 Jan. 2022, commerce.gov/news/blog/2022/01/us-population-estimated-332403650-jan-1-2022#:
3. “Number of Smartphone Users in the U.S. 2025.” Statista, 4 May 2022, statista.com/statistics/201182/forecast-of-smartphone-users-in-the-us/.
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