PP08-56: The Quality and Compliance Benefits to eConsent
Otsuka Pharmaceutical Development & Commercialization, Inc. United States
Failure to obtain proper informed consent as set forth in 21 CFR parts 11, 50, and 56 remains one of the top 5 Common Clinical Investigator Observations from the FDA during a regulatory inspection. This current study will explain how eConsent may be able to address these compliance challenges.
eConsent data from 20 closed clinical trials, totaling 4,231 participants, were used in this analysis to improve understanding the study conduct implications of using an eConsent solution in the clinical trial process.
Eleven phase 1 studies, six phase 2 studies, and three phase 3 studies were included in the analysis. The clinical trial therapeutic areas included 17 CNS trials, 1 nephrology, and 2 dermatology. The status of the consent signature was captured for all potential participants. Of this, 91% of potential participants consented, 8% did not consent, and 1% consented but was missing a counter signature. 27 pediatric participants began the consent process and 26 assented, and 1 needed a counter signature. None of those missing a countersignature were enrolled into the study.
There were 1,932 males and 1,948 females aged 6-79 (Mean=40) who consented using the eConsent solution. Of those who consented to the trial, 100% of participants who received the HIPPA and/or Bill of Rights through the eConsent platform consented to them.
Time spent on the informed consent form was tracked, averaging a total of 13.4 minutes spent on the document. All eConsents also contained a video ranging in lengths from 5.26 minutes to 9.43 minutes. 68% of participants watched the complete video or came within 20 seconds from the complete video. Additionally, all potential participants answered between 3 and 6 knowledge check, or quiz, questions. Scores showed that 97% of participants answered all questions correctly in one attempt.
The data generated by eConsent provides insights of the quality compliance of the eConsent. All consent signatures and assent for pediatric patients were accounted for. Additionally, insights were gained in to the compliance of any counter signatures required as part of the consenting process. By tracking those missing countersignatures, the eConsent technology prevents subjects from continuing with the trial until the consent has been countersigned. eConsent also prevents the ability to consent a participant on an old consent version and will automatically notify clinical site personnel if a patient needs to be reconsented due to protocol changes.
Providing a potential subject with adequate information to allow for an informed decision about participation in a clinical trial, as well as facilitating the potential subject’s comprehension of the information is part of the definition of informed consent as stated in 20 CRF part 50. The data collected through eConsent shows that 97% of potential participants used one attempt to answer all knowledge check questions correctly. This suggests the information provided through the informed consent form and videos was adequate to inform the potential participant. It also suggests participants are evidently informed when they consent to the clinical trial.
Future operational differences can be identified through these data to create a higher quality consent process. This could include reaching out to sites when a participant is missing a countersignature or reviewing knowledge check questions that are answered incorrectly to provide insights on areas in the informed consent form that could be clearer.
The results from this analysis could be used to encourage the adoption of eConsent usage among sites and sponsors to decrease the number of FDA Findings (Investigator Observations) during the inspection process.