3 Steps To Improve Site Acceptance of ePRO in Medical Device Trials

Author: Melissa Newara, Senior Director, Subject Matter Expertise

In the fast-paced medical device trials industry, projected to hit USD 964.90 billion by 2030, streamlining operations, minimizing trial fees and improving data transparency are vital to secure a first-to-market position[1].

To remain competitive and meet their objectives, medical device organizations aim to reduce the development time for medical devices by 25% in the next five years[2]. The adoption of electronic patient-reported outcome (ePRO) collection can help make this goal a reality.

While leveraging new clinical technology is proven to be advantageous, the process could be more straightforward. Many clinical sites already use over 20 IT systems, making integrating new solutions frustrating and complex.

To capitalize on ePRO’s benefits, taking the right approach to site acceptance and adoption is essential. This involves understanding common barriers, engaging and influencing early, and tailoring practical training. In this blog, we’ve outlined the steps to a successful ePRO deployment and provided tips for overcoming common roadblocks.

1. Breakdown the barriers

Implementing a new technology has inherent hurdles to overcome, and ePRO is no exception. Three common barriers to site acceptance include:

  1. Change management
  2. Frustrations with new tech
  3. System incompatibility

The international medical device corporation, Nevro, initially encountered apprehension about their ePRO technology due to perceived risks such as an increased load on patients and site staff.

However, the pandemic offered a valuable opportunity for sites to gain insight into the groundbreaking benefits of digital transformation that ePRO delivers. Although the pandemic assisted Nevro in gaining approval from its sites, sponsors desiring to adopt ePRO can still gain essential insights from their example.

This begins with recognizing and eliminating impediments. As Dr. Frances Rubenstein, Nevro’s Director of Database Management pointed out, data management teams aren’t the only stakeholders requiring involvement for the successful implementation of ePRO. It is vital that all parties involved—especially study sites—are enlightened on and embrace the ePRO agenda.

2. Engage early

To promote successful adoption, it’s crucial to anticipate and tackle barriers early through appropriate site engagement. 

This begins with the study design phase, where sponsors can engage participants to understand what matters most to them while liaising with regulatory authorities early and often to review approaches that best meet participant needs before creating a robust selection process for ePRO platforms.

The next essential step is implementation. To guarantee a successful outcome, it’s important to involve all stakeholders early and throughout the process. This can be accomplished by discussing ePRO during site feasibility assessments, allowing the opportunity for workflow input and creating efficient change management strategies.

With this approach, sponsors benefit from a collaborative approach combined with technology that optimizes endpoint data collection and analysis without adding complexity to workflows, thus helping to prevent any potential issues during site migration from using paper records.

3. Prioritize training

ePRO can improve patient compliance and liberate sites from mundane manual data entry, empowering clinicians to reinvest more time in connecting with participants.

To realize this ideal, training must form part of a trial’s overall project plan, be tailored, and be available on demand. After all, sites are responsible for cascading training to participants, so to maximize ePRO’s potential, sites must first feel confident using ePRO themselves.

Feedback received by sites reinforces this. When asked how they would improve ePRO adoption, sites reference training – including support to integrate ePRO into existing workflows.

In a recent webinar, Proven Practices for ePRO Adoption, Dr. Rubenstein discusses the role training has played in Nevro’s successful rollout of ePRO across several studies. Some highlights include:

  1. Create extensive training resources to support all stakeholders involved
  2. Consistently enhance training materials through user testing to detect and fill in any holes.
  3. Develop engaging video-based resources for sites initiated remotely, field engineers or for self-guided training options.
  4. Equip CRAs with the necessary simulation-based training.
  5. Before seeing participants, include hardware training, such as how to turn on tablets, connect to Wi-Fi networks, and zoom in.

To recap, to improve site acceptance of ePRO, properly understand your sites’ barriers, engage them early in the process, and prioritize effective training. To discover more about improving site acceptance of ePRO, catch the webinar anytime on-demand.


[1] Market Research Future (MRFR), “Medical Devices Market Information By Product Type, Therapeutic Application, End User and Region – Forecast till 2030

[2] GAINING COMPETITIVE ADVANTAGE IN MEDICAL DEVICES How can you optimise time- and cost-to-market in product development? September 2016

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