Mark Maietta, Chief Commercial Officer

Last week, YPrime brought a mix of eCOA experts together to offer perspectives and insight from their experiences during a live panel discussion, entitled The Future of eCOA.

Moderated by Lisa Henderson, Editor for Applied Clinical Trials, panelists included Ken Grice, eCOA Strategist for Bayer and Jonathan Helfgott, Executive Director at Stage 2 Innovations. Jonathan also previously served as an FDA inspector and was one of the authors of the original eSource guidance, issued in 2013. Donna Mongiello, RN, BSN, Vice President of Strategic Solutions represented YPrime on the panel. Discussion centered on a handful of eCOA and eSource topics that facilitate a shift to remote and virtual trials, and promise convenience and support to trial participants, while delivering efficiencies and higher data quality to sponsors.

Opening the discussion, Lisa polled the audience about decision-making criteria for eCOA implementation. The majority of the audience selected data utility, followed by therapeutic areas and cost as the most important criteria for eCOA implementation at their organizations.

Ken spoke first, describing the results as encouraging, “as cost is often the reason many sponsors cite for not choosing eCOA.” He shared examples where Bayer uses home-based diaries and questionnaires to collect endpoint data. He also provided a few examples of where paper may still be used. “In these situations,” he added, “limited data collection typically takes place at a site level and are not related to primary endpoints.”

In providing regulatory perspective, Jonathan echoed Ken’s comments and talked about how data utility and therapeutic areas are intertwined, using examples of pain and asthma studies to illustrate how ePRO can only measure specific types of effects. He summarized rationale that clinical technology providers have used for years when he stated, “There’s an overwhelming amount of evidence to support the fact that eCOA provides superior data quality when compared to paper.” He then recommended eSource by pointing out, “data collected on paper ultimately ends up in an electronic format on the back end, so why not remove that step and use technology to collect data directly.”

The obligatory question of eCOA cost came up. Ken responded by stating “while there’s often no line item for paper in a study budget, paper is not free.” After explaining where the hidden paper costs appear, he advised the audience to develop their own models that identify where paper costs appear. In most models, paper drives up the costs of monitoring, data cleaning and printing.

All panelists mentioned the cost of compliance as compelling reasons for upfront investment in eCOA.

“There’s a lot of ROI in the data quality you get, as well as the ability to monitor data in real-time for safety and even for operational reasons,” Ken stated.

As the discussion shifted to BYOD implementation, Lisa again polled the audience. The first question asked viewers if they had considered implementing BYOD as part of an eCOA strategy. In response, 76% of the audience have considered implementation, while 24% had not. However, when it came to the second question, which asked viewers if they had actually implemented BYOD, only 16% of viewers selected yes.

None of the panelists expressed surprise at poll results, acknowledging that it’s much harder to implement than consider. Ken and Donna outlined some of the hurdles to BYOD implementation, including privacy, logistics and the need to provision some devices for participants.

Reinforcing the FDA position on BYOD, Jonathan reminded the audience that provided the right controls are in place, such as audit trails and access control, and the right testing and validation is performed, BYOD is acceptable.

The flexibility for both eCOA and BYOD afforded by cloud computing was discussed at length. In Donna’s view, cloud-based eCOA allows multiple devices to share the same data.  “This can be really beneficial when you’re collecting data on a tablet at the site as you don’t need to restrict patients to a specific device. Cloud-based eCOA also allows for a ‘one-size-fits-all’ solution meaning you build an instrument once and it can be used in any modality.  The cloud permits things like dynamic scaling of an instrument so that it appears the same on the variable size device screens you might find with BYOD.  And of course, a cloud-based platform allows for offline PRO completion, which can be critical for eCOA.”

Donna stated that most sponsors using BYOD now will opt for a hybrid model, mixing provisioned devices with patients’ own phones. Perhaps one of the biggest benefits of BYOD, she argued, is the ability of sponsors to repurpose their provisioned device inventory to support a hybrid BYOD model. “In a cloud-based environment, sponsors can mix their inventory and not worry about the fact that someone is using a Motorola, while someone else used an HTC model.”

Ken also spoke to the benefits of the hybrid model, stating that “getting away from having to provision large inventories of a single model of device that may go end of life before the end of a trial would remove a lot of the burden from sponsors.”

Donna suggested that in spite of the industry push for patients to use their own device, many people may prefer to use a separate device, due to privacy concerns and the fact that a third party may have access to data on their phone through an app. “This is a relatively new concern that didn’t materially exist a few years ago,” she added.

Jonathan challenged the notion that patients may prefer separate devices, but also mentioned the diversity of patient populations necessitate the understanding of the preferences and potential limitations of trial population. “Sponsors should evaluate these considerations and the tradeoffs, and make decisions accordingly,” he said.

Lisa asked panelists about how eCOA will be affected, after stating the BYOD model is a natural progression to the virtual, or site-less clinical trial model.

Jonathan predicted that the integration of eCOA with telemedicine and more tools for patient support will usher in the virtual trial will positively impact the ability to attract and retain more clinical trial participants, offering scenarios where patients can interact with study staff from their car or while on vacation. Ken agreed, mentioning the complement of wearables and sensors to collect exploratory and ancillary data.

Donna spoke about the future opportunities related to the powerful combination of subjective ePRO data with the objective data provided by wearables.

The discussion on wearables and sensors lead to agreement on striking a balance with data collection against the risk of overburdening the patient and site. According to Jonathan, academic organizations tend to have a broad approach for data collection, while biopharma sponsors tend to prioritize what’s absolutely necessary for the study. Jonathan also advised involving multidisciplinary teams in eCOA design, to ensure the best chance of making the right decision as to how much or how little data are collected.

The panel discussion concluded with the subject of patient engagement. Ken made a distinction between the fundamental engagement inherent with patients’ routine use of a device and more sophisticated engagement activities, such as messaging, two-way communications that allow patients to feed back information based on their own data, trial status and other information-rich activities. Donna spoke to the effectiveness of gamification as an engagement solution through examples such as the use of badges and appropriate incentives for completing various tasks or meeting certain study milestones, (including completion of daily assessments, adherence to study medication, and compliance with study visit attendance, among others).

For additional information on the same topic, Jonathan mentioned a white paper from the Clinical Trial Transformation Initiative on considerations and recommendations, scheduled for publication in July. Lisa plans to publish a discussion summary in a forthcoming issue of Applied Clinical Trials.

Click here to watch an archive version of this webinar.