eCOA Flexibility in Clinical Trials: The Site Perspective

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As medical product development drives advances in medical knowledge, clinical trials continue to become increasingly complex, potentially adding burden to trial sites that already face challenges while executing a protocol. Electronic clinical outcome assessment (eCOA) data collection in clinical trials has increased significantly since the first implementations in the 1990s.¹ Evidence demonstrates how eCOA improves data quality^2-5 and potentially reduces the burden of paper-based data collection.

However, sites report that eCOA can be disruptive, impact participant engagement and protocol compliance, and may feel that eCOA systems demand specific skills and resources.Consequently, there is a collective need to identify areas for simplification and flexibility to reduce that burden.

In 2019, the Critical Path Institute launched the eCOA: Getting Better Together Initiative (GBTI) to identify the root cause of issues with eCOA implementation in clinical trials. To address the clear need to embed flexibility in eCOA use, the Support Flexible Approaches to PRO Data Collection project was launched.

The project explored three areas via separate workstreams:

• The innovations in technology required to support flexibility.
• The expectations of measure owners and regulators.
• The impact on clinical trial sites and clinical research associates (CRAs).

The latter workstream is the focus of this article. This workstream solicited site staff and CRA perspectives on eCOA-related challenges and collected suggestions for simplification and increasing flexibility.

The team developed a web-based questionnaire and enlisted representative groups to distribute the questionnaire via snowball sampling to trial site professionals and CRAs for anonymous completion. The research explored various categories ranging from study oversight, solution-related issues, and helpdesk experiences to eCOA backup preferences and general recommendations for improvement. This article highlights the key findings related to site readiness and training, participant experience and compliance, and eCOA technology. See the full publication for complete results.⁶

Site readiness and training

Generally, respondents reported feeling positive when learning that eCOA would be used, and indicated an appreciation of the value of eCOA. However, the results indicate a need to better prepare sites to use eCOA. Respondents described an insufficient assessment of their eCOA experience, and few opportunities to practice before enrolling the first participant.

Study participant experience and eCOA compliance

When asked about their impression of trial participants’ attitudes toward eCOA, 97% of respondents reported that participants are positive about eCOA at least some of the time.Participant and site attitudes may impact participant compliance with the study protocol as well as the eCOA-related procedures. The principal reasons for participant non-compliance were unfamiliarity with eCOA and device-related issues such as data connectivity.

Technology and BYOD experience: Survey results suggested that respondents experience frustration with device functionality, battery life, charging, and internet connectivity issues.Participants not charging or carrying their devices may be overcome with a bring-your-own-device (BYOD) approach, which provides a level of familiarity and convenience not afforded when the participant is assigned a study-specific provisioned device (PD). While the respondents reported a slight preference for BYOD, a third of the sample reported no preference for either BYOD or PD.

eCOA backup solutions: Regardless of device approach, backup solutions can minimize noncompliance, particularly when a participant loses or breaks their primary device. The use of electronic backup solutions, which retain the advantages over paper data collection and minimize data loss, is an established best practice.⁷ While all survey respondents agreed that a backup should be provided for PDs, a third reported sponsors rarely or never provide backups, and almost half reported backups are provided only “sometimes”.

eCOA helpdesk: Technical support via a helpdesk is a key component of eCOA system provision, and while some respondents reported usually being able to address device issues themselves, the ability to resolve issues independently is desired; and when they do contact the helpdesk, they expect quicker resolution.

Despite some acknowledged limitations, this research contributes to characterizing the reasons that hinder the use of eCOA solutions. The recommendations proposed in the full publication6 may enhance flexibility and improve eCOA-system usability.

Authored on behalf of Critical Path Institute’s eCOA Consortium by Estelle Haenel, Chief Medical Officer, Kayentis; Celeste A. Elash, Vice President, eCOA Science, YPrime; and Scottie Kern, Executive Director, eCOA Consortium.

References

1. Shiffman, S.; Johnston, J.A.; Khayrallah, M.; et al. The effect of Bupropion on Nicotine Craving and Withdrawal. Psychopharmacology (Berl). 2000. 148 (1), 33-40. https://link.springer.com/article/10.1007/s002130050022
2. Coons, S.J.; Eremenco, S.; Lundy, J.J.; et al. Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials. Patient. 2015. 8 (6), 301-309. https://link.springer.com/article/10.1007/s40271-014-0090-z
3. Stone, A.A.; Shiffman, S.; Schwartz, J.E.; Broderick, J.E.; Hufford, M.R. Patient Non-compliance with Paper Diaries. BMJ. 2002.324 (7347), 1193-1194. https://www.bmj.com/content/324/7347/1193
4. Shields, A.L.; Shiffman, S.;Stone, A. Patient Compliance in an ePRO Environment: Methods for Consistent Compliance Management, Measurement, and Reporting. In Byrom, B.; Tiplady, B. (Eds.), ePRO: Electronic Solutions for Patient-Reported Data. 2010, Gower. 127-142. https://books.google.com/books?hl=en&lr=&id=l60oDAAAQBAJ&oi=fnd&pg=PA127&ots=Pg4Z-TJM3k&sig=BL2qk_FlZCuCJhVkC1i7IzXO03c#v=onepage&q&f=false
5. Ganser A.L.; Raymond, S.A.; Pearson J.D.; Data Quality and Power in Clinical Trials: A Comparison of ePRO and Paper in a Randomized Clinical Trial. In B. Byrom, B.; Tiplady, B. (Eds.), ePRO: Electronic Solutions for Patient-Reported Data. 2010, Gower. 49. https://www.researchgate.net/publication/345313213_Data_Quality_and_Power_in_Clinical_Trials_A_Comparison_of_ePRO_and_Paper_in_a_Randomized_Trial.
6. Haenel, E.; Elash, C.; Garner, K.; Turner, M.; Kern, S., on behalf of the Electronic Clinical Outcome Assessment (eCOA) Consortium and the Patient-Reported Outcome (PRO) Consortium. Flexible Approaches to eCOA Administration in Clinical Trials: The Site Perspective. Contemporary Clinical Trials Communications. February 2024. https://doi.org/10.1016/j.conctc.2023.101241
7. Howry, C; Elash, C.A; Crescioni, M.; Eremenco, S.; O’Donohoe, P.; Rothrock, T. Best Practices for Avoiding Paper Backup when Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials. Ther. Innov. Regul. Sci. 2019. 53 (4). 441-445. https://link.springer.com/article/10.1177/2168479018785160