Electronic patient-reported outcomes (ePRO) have been around the clinical research industry for years, but the rapid growth in decentralized trial adoption and other factors have helped cause ePRO use to soar. Outsourcing-Pharma recently connected with Sachin Bharadia, account manager with contract research organization (CRO) Phastar about ePRO challenges, how COVID-19 has impacted ePRO use, and benefits of the technology.
OSP: Could you please talk about the evolution of ePRO in clinical trials? When did it arrive on the scene, and how has understanding and use of the technology evolved?
SB: I’m not 100% sure about when ePRO arrived on the scene. I would say over the last 20 years it has obviously evolved significantly. The accelerating movement from paper diaries and questionnaires to ePRO data collection systems has enhanced the integrity and accuracy of data collected in clinical trials.
Not just the evolution from paper to electronic record, but even within electronic capturing of data there have been big shifts: from Interactive Voice Response Systems (IVRS) by telephone, through to site-based desktop/laptop (web-based applications), to tablets/handheld devices (largely provisioned stand-alone devices) right through to BYOD, which is where we are currently allowing participants in a clinical trial to use their own computer devices (e.g., smartphone, tablet, laptop, desktop PC) to access and respond to study-related PRO questionnaires.
OSP: How has the arrival of COVID-19 impacted its deployment?
SB: I would say COVID-19 has impacted how ePRO is deployed in trials as opposed to a major shift in the deployment of ePRO itself in trials as a whole. Patient-reported outcomes will or will not be required as per trial protocol requirements (in terms of what data is required to be collected) regardless of the impact of COVID.
I would say the main impact has been to move away from provisioned devices and site-based ePRO data collection, this has seen an uptick in BYOD and the contracting of vendors who provide app-based ePRO software for collecting data.
OSP: What are some of the aspects of research impacting ePRO use?
SB: Decentralized trials, wearables, and remote monitoring are solutions that work around ePRO. If we are talking about aspects of research impacting ePRO use, then I’m thinking about factors that may have an impact on the type of ePRO to be used (site-based, device, app-based, etc.) depending on the trial, site, country, etc.
OSP: Please share some of the advantages of using ePRO.
SB: ePRO systems can lead to more accurate and complete data, improved protocol compliance, avoidance of secondary data entry errors, less administrative burden, high respondent acceptance, reduced sample size requirements, and potential cost savings.
OSP: Could you please talk about what are some of the challenges and special considerations trial teams must deal with when using ePRO?
SB: Compliance through the right training is special consideration with ePRO. It can be said that the many advantages of ePRO data capture may not materialize if study subjects do not receive adequate training on the ePRO device/system and the data entry requirements of the study protocol.
For example (and this is taken from the FDA’s PRO Guidance, which sums it up quite nicely), “If a patient diary or some other form of unsupervised data entry is used, we plan to review the clinical trial protocol to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected.”
OSP: Can you share some of the tools and strategies sites and sponsors can consider when using ePRO?
SB: I think that is dependent on the trial and/or therapeutic area or even location of the site(s). However, when considering ePRO now, there are so many choices depending on what is involved in the trial and what is being asked of the patient.
I also think sponsors will consider patient engagement features. Also, the design process itself and how quickly it can 'go live' in time for first-patient-in (FPI). As always, there is also the cost to consider: both upfront and potential savings further along in the life-cycle.
Not all vendors, or sponsors, or trials are the same: therefore, one solution does not fit all. Some ePRO vendors will have more experience in certain therapy areas compared to others, some sponsors will have sites and staff already experienced with a particular device or software.