eCOA implementation best practices: a guide to implement an eCOA strategy geared towards patient-centricity

, , ,
Melissa Mooney, IQVIA

eCOA implementation best practices: a guide to implement an eCOA strategy geared towards patient-centricity

By Melissa Mooney

In a wave of advanced technology and decentralized clinical trials, sponsors have turned to electronic tools such as electronic clinical outcome assessments (eCOAs) to capture patient reported outcomes data.

As with any trial design consideration, incorporating eCOAs into a clinical protocol involves careful planning and a well thought out strategy. Working with a partner who can provide COA strategy consultation during the protocol development phase, as well as oversee every aspect of mapping that strategy to an electronic solution, is a sure way to enable collection of quality data fit for purpose. 

Addressing challenges and demands

A robust eCOA implementation strategy can minimize several implementation challenges associated with a clinical trial, including: 

  • Quick and accurate mapping of COA measurement strategies from clinical protocols into an eCOA technology solution
  • Development of eCOA implementations that meet eCOA protocol requirements while minimizing the burden on patients and sites
  • The scope and time required to implement eCOA into a trial, including finalization of the eCOA design, conducting user acceptance testing (UAT), development and facilitation of patient and site training, data monitoring, and eCOA risk management

Developing a successful eCOA strategy by understanding best practices

Effective eCOA strategies can improve the patient experience, create product differentiation and support label claims and payer support. To achieve this, eCOAs must be constructed by scientific and technical experts who are knowledgeable about creating COA strategies and translating them into eCOA implementations. In clinical protocols, COAs should be included as early as possible. Furthermore, the FDA has published PRO guidance and established high standards for data-driven COA development. Sponsors should consider these recommendations:

1. Build an eCOA solution upon a stable COA strategy. To create an effective eCOA solution, the study protocol must have a clearly defined COA strategy. If sponsors implement an eCOA solution with an incomplete protocol or strategy, they could miss or collect inconsistent data.

2. Prioritize the patient experience. Consider patient burden and experience as you finalize your eCOA strategy. By inviting actual patients to pilot the eCOA solution as part of usability testing, sponsors can incorporate valuable patient feedback into finalization of the protocol and/or eCOA strategy. 

3. Provide a user-friendly interface. For eCOAs that are collected as part of site visits, healthcare professionals (HCPs) are available to answer questions, and to support patients in understanding and navigating the technology. eCOAs completed remotely, however, require the patient to complete the entire assessment without assistance from an HCP. Therefore, it is critical that the eCOA instructions are clear and that the technology for patients to navigate through the screens, select responses and submit them is straightforward.

4. Leverage a pre-existing assessment when possible. Design time can be reduced from several weeks to a few days when a sponsor’s COA strategy incorporates pre-existing assessments from an eCOA library. While this greatly reduces eCOA startup timelines, it’s important to select the right COA to align with your endpoint strategy. Sometimes this requires development of a new COA. A newly designed assessment is likely to add considerable time to your timelines as they typically require cognitive debriefing, usability testing and psychometric validation for purposes of regulatory submissions.

5. Provide a bring your own device (BYOD) option. Traditionally, sponsors provided patients with provisioned devices exclusively used for study completion. With the evolution of technology and emphasis on patient-centricity, BYOD options have proven to minimize patient burden by allowing patients to complete eCOAs on their own devices resulting in higher eCOA completion rates. A BYOD option will expedite eCOA start up timelines and eliminate costs and time with the procurement, management and shipment of provisioned devices. A standard BYOD offering will also include a percentage of provisioned devices to accommodate patients who are unable or unwilling to use their own device. 

6. Conduct and document UAT. A thoughtful and well-documented UAT is crucial to ensuring that the software is usable from the patient and site perspectives and aligns with the protocol intent. A robust UAT will result in a UATpackage that will satisfy regulatory requirements including a UAT test plan, scripts and documentation of findings. Furthermore, UAT serves as a checkpoint to identify potential risks that can be further mitigated via updates to the eCOA solution design, training materials and eCOA monitoring.

7. Provide patients and sites with appropriate training and support throughout the conduct of the trial. Once the eCOA is ready for launch, support should be available to sites and patients from day one. That includes providing training materials for site staff and patients on how to download and use the eCOA technology, review patient responses and monitor compliance. Additionally, a helpdesk should be available to support patients and sites in their local language throughout the duration of the trial. All of these things will further ensure successful adoption of the eCOA in the trial environment.

Supporting a patient-centric future

Sponsors are increasingly seeking strategies that align better with modern technology and patient preferences as healthcare shifts toward patient centricity. By using a comprehensive eCOA implementation strategy, the principles that drive a patient-centric experience will continue to be achieved while enabling a more holistic interpretation of clinical results. The right strategy aims to provide a better understanding of a treatment’s impact and efficacy through collection of patient-relevant endpoint data. Through these best practices researchers will be able to design eCOA strategies that collect quality endpoint data while ultimately enhancing the patient experience. 

Melissa Mooney is director of eCOA solutions, engineering at IQVIA eCOA, IQVIA.