How Covid-19 has Changed the eCOA/ePRO Landscape
Donna Mongiello RN, BSN, Vice President of Strategic Solutions, YPrime
The disruption caused by the coronavirus pandemic necessitated significant changes to the way we all work and live. The pandemic also may be the catalyst to examining how we can quickly adapt to crises that impact the drug development industry and speed up adoption of technological tools to meet current and long-term needs.
Many biopharmaceutical companies had to decide whether to suspend, modify, or even cancel their existing clinical trials. They had to reprioritize their 2020 pipelines which had been years in the planning, and this meant pushing out some trials and cancelling others due to the addition of new treatment or vaccine studies for COVID-19. Sponsors who were already using technology to collect clinical outcome assessments electronically in their clinical trials had fewer disruptions in keeping COA data collection flowing.
By mid- to late March 2020, when stay at home orders were enacted in hot spots like New York and New Jersey, many of the sponsors we support started to inform us of site closures and many scenarios where, due to lockdowns or patient health concerns, patients were no longer able or willing to attend site visits. This led to questions from our sponsors regarding how we could collect site-based data from patients at home. There were several things we needed to consider:
- First, we needed to figure out how to administer site-based patient-reported outcome (PRO) assessments to patients who could no longer travel to sites, whether due to site closures, lockdowns, or health fears. And how sites that were closed could continue to collect clinician-reported outcome (ClinRO) assessments.
- Second, what technology did patients and sites have in their own homes—did they have the capability to continue uninterrupted electronic data collection from home or did we need to use paper?
- Third, and very importantly, if the mode of completion changed from site-based tablet to paper or web, or from patient-completed to interview, would instrument authors approve and would data comparability be at risk? Overwhelmingly, instrument authors approved, and in March 2020 the FDA, EMA, and MHRA all released guidance documents on the management of clinical trials during COVID-19. These guidance documents acknowledged sponsors may need to evaluate alternative methods for assessments, like remote data collection, phone contacts or virtual visits, and stressed the importance of documenting any deviations from the planned method of data collection.
To assist key industry stakeholders making those decisions, The Critical Path Institute (C-Path) released their own risk assessment and mitigation strategies guidance1 that included, among other recommendations, a decision tree document to outline the pros and cons of alternative site-based PRO data collection methods in scenarios both when the patient continues to attend scheduled clinic visits and when clinic visits are not possible.
Alternatives for remote PRO data collection to replace site-based ePRO data collection include:
- Remote web-based ePRO data collection
- Sites interviewing patients via telephone and completing the ePROs on the patients’ behalf
- Bring Your Own Device (BYOD) remote data collection and patients completing paper versions of the PROs at home
Based on C-Path’s pros and cons lists for each option, web-based data collection is the most desirable for ensuring patient safety and data integrity, while paper-based is the least.
YPrime innovated very quickly to offer the best option for our clients, one that was in line with C-Path’s guidance. YPrime already had a web backup solution available for our tablet and handheld devices, but it did not allow for patients to complete site-based PROs off-site. In the space of about 3 weeks and with input from our strategic sponsor partners, we were able to enhance our web backup to allow a URL to be emailed to the patient’s personal email address delivering an exact replica of the tablet on the patient’s own web-enabled device. In this way, PROs remained PROs.
Sponsors engaged with partners like YPrime in collaborative brainstorming to proactively plan how to manage within this pandemic and any future pandemic. They used lessons learned from their active trials to plan mitigation strategies for their upcoming trials. They considered everything from potential courier service issues, site closures, training, patient setup, and more.
By nature, our industry is conservative and typically does not immediately adopt new technologies, but the pandemic forced their hand and required implementation of proven but infrequently implemented technologies. BYOD is an example of technology that has been around many years, attracted early interest, but sponsors were not ready to implement, largely due to regulatory concerns and other considerations such as reimbursement of data charges. The pandemic has pushed BYOD into the mainstream, and we are seeing many requests for this now. Other technologies that are becoming more important are eConsent, telemedicine, wearables, and sensors. With more sponsors using these technologies, everyone is learning together that there are fewer risks involved and real value is added to the clinical trial.
The Future of Clinical Trials
The pandemic has shown us that while web-based PROs were not regularly implemented in the past, they are excellent methods for collecting PROs from patients virtually. It allows for the same quality data without the need for a provisioned device or a physical clinic. In addition, patient burden is lessened because we are not requiring them to travel to a clinic to answer a few questions. There may be additional unknown benefits, for example, improving patient recruitment. Everyone is now more open to understanding and adopting the benefits of technological tools for remote-based and virtual trials.
The bigger picture is to look at what future technologies can offer and how to speed their adoption. There is real potential to setting new clinical trial standards resulting in better recruitment, patient diversity, reducing patient burden, and ultimately collecting better data. Most of the industry will not utilize all available technologies, so identifying key technologies and demonstrating their value will be important. We will experience growing pains as technology, with all its benefits, also adds complexity. I remain hopeful that we will work out any difficulties and see the net value technological tools can bring.
1 C-Path Institute ePRO and PRO Consortium: Coronavirus Disease 2019 (COVID-19): Risk Assessment and Mitigation Strategies for the Collection of Patient-Reported Outcome Data through Clinical Sites, 5 JUN 2020, https://c-path.org/wp-content/uploads/2020/06/COVID-19_CPath_v3.0_2020JUN5.pdf