PP02-27: Clinical Trial Enrollment and Retention with eConsent vs. Paper Consent
Associate Director, Applied Innovations
Otsuka Pharmaceutical Development and Commercialization United States
The purpose of this study is to compare the outcomes of eConsent versus paper consent in the United States as it relates to screen fail, enrollment and retention rates.
8 clinical trials were identified as having data for both eConsent and paper consent. To control for cultural differences, the data used in this analysis contained 2,353 participants within the United States only. 999 participants used a paper consent and 1,354 used eConsent.
Analysis contained 3 phase 1 trials (N=202), 2 phase 2 trials (N=848), and 3 phase 3 trials (N=1217); totaling 1,496 participants. Participants ranged in ages 7-65 with an average of 44.7 years. Sex was available for 2,166 participants. 49.9% of participants were female.
Within each consent group (eConsent or paper), screen failure and retention rates were calculated. Of the participants who used eConsent, 33.3% (N=333) screen failed and the remaining 66.6% (N=666) were randomized. 38.7% (N=524) of the participants who used a paper consent screen failed, and 61.3% (N=830) were randomized. Of the randomized participants who used eConsent, 74.8% completed the clinical trial. 83.6% of the randomized participants who used a paper consent completed the trial.
Randomized participants were broken into 6 ages groups: 7-17y (N=38), 18-29y (N=111), 30-39 (N=238), 40-49y (N=401), 50-59y (N=418), and 60-65 (N=109).
Those who used eConsent in the 7-17y age group had a trial completion rate of 87.5%, and those who used paper consent had one of 78.6%. The next age bracket of 18-29y had an eConsent completion rate of 64%, and a paper completion rate of 59.6%. Those aged 30-39 who used eConsent had a 60.0% completion rate, and paper had an 83.46% completion rate. Completion rates for those aged 40-49y were 72.7% for eConsent, and 87.0% for paper. For ages 50-59y, eConsent completion rate was 66%, and paper was 83.8%. The last age bracket of those aged 60-65y had an eConsent completion rate of 71.4% and a paper completion rate of 85.1%.
Differences across trial phases, type of consent, and completion rates were also analyzed. Randomized participants in phase 1 studies that used eConsent had a 92.7% completion rate, whereas paper had an 82.7% completion rate. Phase 2 randomized eConsent participants had a completion rate of 71.1%, and paper was 76.2%. Completion rate for eConsent participants randomized in a phase 3 study was 59.9%, and paper was 85.6%.
These results provide potential considerations when designing the consent process for a clinical trial. Based on the above results, age and trial phase are correlated with differences in participant retention among consent types. Participants under the age of 30 who used eConsent had ~9% higher completion rates than those who used paper consent. Additionally, phase one studies had a ~10% higher completion rate with eConsent compared to paper consent. The overall analysis indicates that paper consent is correlated with a ~9% higher completion rate than eConsent. This analysis does not take into consideration of cofounding factors that may affect trial completion rates. This may include adverse events, lack of efficacy, and non-compliance. Additionally, it could be possible the participants who used eConsent better understood their rights to withdraw from the study. Knowledge check scores indicate 98% of participants knew they could withdraw at any point during the study; however, this was not measured in paper consent.
Regardless of the above, there are numerous benefits to eConsent, such as the ability to collect data on read times, video watch times, and knowledge check scores. This data can be used to identify participants who may be more engaged in the consent process, as well to provide insights into patient comprehension and study understanding. Knowledge check scores can also help sponsors identify areas in the informed consent document that may require better explanation. Additionally, eConsent may have regulatory and quality benefits, as it will automatically notify sites if a patient needs to be reconsented due to protocol amendments and prevent randomization of participants who have not been officially consented.
The results of this study can help sponsors determine which type of consent (eConsent or paper) is best for the type of clinical trial they are conducting.