One of the many challenges pharmaceutical companies and CROs face during the development of new compounds is keeping patients enrolled and compliant throughout the duration of each clinical study. As many as 30% of patients drop out of trials1 – a fact that highlights just how important it is to keep patients motivated and engaged, as well as making it as easy as possible for them to participate.
Improving Protocol Compliance
When using electronic Clinical Outcome Assessments (eCOA) ─ especially electronic Patient Reported Outcome (ePRO) ─ for important patient data capture, compliance levels can reach well over 90% compared to as little as 11% with paper-based methods (Figure 1).1 But why?
Patient protocol compliance tends to increase and study drop-out levels fall when patients are more engaged with the clinical trial. This can be accomplished, for example, by providing motivational, educational and reminder messaging through the electronic device. Another important factor is the design of the assessment itself — and the fact that ePRO makes it easy for patients to access, complete and submit their questionnaires at the times required by the study protocol.
ePRO also allows you to configure workflows specific to your unique protocol with validated controls and edit checks that prevent patients from completing diaries in batches just prior to a site visit (i.e., ‘parking lot syndrome’) or filling out data in advance. For example, research shows that 45% of patients using paper diaries in a pain study invented data by forward filling their diaries at least once.2
Unlike paper methods, which offer no controls over data entry timeliness or quality, ePRO provides timestamps of each patient’s entries, removing any doubts regarding patient protocol compliance and giving you confidence in the reliability of the captured data.
Capturing Sensitive, Personal Patient Information
Research shows that patients are more willing to provide complete data when given the opportunity to record symptoms and other feedback without embarrassment.3 In a study of patients with breast cancer, there was a higher response rate for a question on satisfaction with current sex life among those who responded on an electronic diary (eDiary) compared to those using traditional paper diaries. ePRO gives patients confidence that caregivers and family members don’t have access to personal information, which improves patients’ willingness to comply with and stay engaged in study protocols.
Clinical trial sponsors and CROs need patients to remain committed to study protocols, which requires the use of proven tools to improve patient engagement during clinical trials. Research has found that 86% of patients have a preference for ePRO.4 So, why not give patients what they want – and benefit from the increased engagement and protocol compliance ePRO delivers?
This concludes our series on how sponsors and CROs of all sizes benefit from using electronic vs. traditional, paper-based data capture. Be sure to read the earlier installments:
- What Is eCOA and How Does It Improve Data Quality?
- Improving Efficiencies and Insights to Clinical Trial Performance through eCOA
Chris Watson, PhD, is the Director of Product Strategy, Digital Patient at ERT
- “EDC and eCOA/ePRO Market Dynamics and Service Provider Performance,” ISR, 2015.
- Stone, A. A., Shiffman, S., Schwartz, J.E., Broderick, J.E., Hufford, M.R. (2002). Patient non-compliance with paper diaries. British Medical Journal, 324, 1193 – 1194.
- Dupont, A., Wheeler, J., Herndon, J.E., Coan, A., Zafar, S.Y., Hood, L., Patwardhan, M., Shaw, H.S., Lyerly, H.K., Abernethy, A.P. (2009). Use of tablet personal computers for sensitive patient- reported nformation. Journal of Supportive Oncology, 7, 91-97.
- Waehrens, E.E., Amris, K., Bartels, E.M., Christensen, R., Danneskiold-Samsøe, B., Bliddal, H., Gudbergsen, H. (2015). Agreement between touch-screen and paper-based patient-reported outcomes for patients with fibromyalgia: A randomized cross-over reproducibility study. Scandinavian Journal of Rheumatology, 44 (6), 503-510.