Bring-Your-Own-Device For eCOA — Is It Worth It?
By Abby Proch, executive editor for guest columns, Clinical Leader
Clinical trial teams whose studies require patients to use digital devices to record information such as COAs and PROs have the choice of paper or digital means. Using smartphones and tablets has gained prominence in recent years, but has yet to replace paper-based documentation. And it’s one reason a panel of experts across sponsors, sites, and vendors convened at the 2025 SCOPE Summit.
The four experts — Valerie Balosso, director, data management, infectious diseases at GSK; Lynne Cesario, executive director, global lead risk based monitoring program at Pfizer Global R&D Groton Labs; Dan Kearney, CEO of CNS Healthcare; and Pankaj Shukla, senior director, strategic accounts at Clario — weighed the pros and cons, the easy gains and the challenges, to adopting digital devices, specifically bring-your-own-device (BYOD) requirements for clinical trial eCOAs.
3 Big Wins For BYOD
Very simply, the BYOD option can save money, support a better patient experience, and improve data collection, said the panel. To start, the money a sponsor company would have spent on providing devices can be saved and used in other ways for the trial, explained Balosso.
She further explained it is a better user experience because the patient is already familiar with the operations of their device/phone, whether Apple or Android or something else. Another added bonus is that the ecological footprint is much smaller, said Balosso.
Cesario says that BYOD for eCOA provides less “missingness of data” and high compliance, something she experienced working in the vaccine space. Additionally, because a team could analyze the data in real time, they were able to observe and address early challenges in reporting adverse events appropriately, thus preserving the validity of future data.
BYOD Can’t Be The Only Option
As BYOD concerns the sites, Kearney extolled the ability to allow patients to choose their device or have one provided by the sponsor. He recalled when a study required patients to use their own device, with no other option. However, some patients didn’t have data plans on their phones to support a specific app. When Kearney raised the issue to the sponsor, the sponsor concluded that those patients just couldn’t join the trial. Rather than letting that be a barrier to the patients’ participation, Kearney’s staff bought “burner phones” for about 40 patients to use during the trial, thus enabling their participation.
Balosso, too, called for balance in device expectations, allowing the flexibility for patients to use their phones or have them supplied by the sponsor of the trial.
As for keeping paper reporting in the mix, Balosso was not so keen. However, Kearney said that tech isn’t reliable enough to abandon paper completely. He said his sites want to pull out paper forms when devices or technologies fail, but sponsors won’t allow it. He asked the panelists and audience to consider the predicament.
When asked by the panel moderator about how BYOD might affect the ability to achieve more diverse enrollment in a clinical trial, Kearney defined diversity broadly.
“From a site perspective, real diversity includes a lot more than [race], it includes socioeconomic diversity, it includes sexual orientation, it includes gender. It also includes things from a therapy perspective that medically might prevent a patient from wanting to use their own cell phone to enter their data,” he said.
Kearney was referring to patients with mental health conditions, such as anxiety, who worry about using their personal device and risk inadvertently sharing personal data. Kearney, whose sites conduct clinical trials for mental health conditions and therapies, said he’s known prospective participants to back out of trials for that very reason.
Regulators Scrutinize BYOD Data
Regulators, such as the FDA, have specific and challenging questions about data collected via BYOD and the attributability of that data to individual patients, explained Cesario. The issue is paramount, as more than 75% of data from the case report form space is coming from eCOA, said Cesario. Looking in-house, Cesario said that two-thirds of GSK studies have endpoints tied to the eCOA data. The sheer size of data is challenging, but so are methods for asserting its validity.
Regulators are focusing on the data entered by patients as well as the metadata behind it, she said. They want to make sure ALCOA (attributable, legible, contemporaneous, original, and accurate) principles are covered, with the quality and integrity of the data upheld. However, things like varied device encryption approaches, such as multi-factor authentication (MFA), 4- and 6-digit PINs, and/or biometrics can make it challenging for sponsor companies to deliver data cleanly. Regulators have requested PIN reports (which she said GSK won’t give) to ensure data is not fraudulently submitted, say by site staff. To meet regulatory expectations, GSK instead shares reports that show data is collected at different times and frequencies to illustrate that it’s being collected in situ and not by a dishonest, orchestrated effort.
Sites Need Tech Support
Having the only site perspective of the group, Kearney illustrated the challenges site staff experience with BYOD, whether that’s for eCOA or something else. His complaints spread to the wider issue of having technology and applications handed down by sponsors and CROs.
Kearney relayed an issue that the day before the Summit, his site staff was scrambling to fix tech issues experienced at another site. And then, in general, he lamented, “We gotta delete the app, we gotta download the app, we gotta log back into the app. … We need to find an easy way for when things don’t work, to make it simple for patients and sites to be able to figure out the solutions.”
Part of the problem is the lack of support offered by sponsor companies and/or their technology vendors.
“We’re not seeing tech support catch up to the amount of solution providers,” said Kearney.
And until the numbers catch up — until a person on the other end of the phone line has “reported it to IT” — Kearney asked for clarity and flexibility. To sponsors, he said: “Be very clear about what is OK as a backup and what is not OK as a backup when there is a tech problem.”