eConsent in Clinical Research: Overcoming the Challenges of Protocol Amendments
Electronic informed consent (eConsent) tools are emerging as a valuable solution in the quest to deliver a more patient-centric clinical trial experience. eConsent platforms take the complex paper consent document and transform it into a multimedia, interactive digital experience that translates protocol into patient-friendly language and appeals to most learning styles to improve patients’ understanding of their obligations – leading to better engagement and compliance. However, the technology alone is not a panacea.
Creating and deploying eConsent will unavoidably require an investment of time, human ingenuity and patience. What’s more, even after making this investment to design an optimized eConsent, the inevitable protocol amendments must be addressed in the platform or else could severely inhibit its functionality and delay ongoing or new patient visits. For this reason, organizations must consider how to overcome the challenges to reap the full benefits of eConsent adoption.
The challenge: protocol amendments and the hinderances of paper informed consent
Protocol amendments are a common part of clinical trials, and yet they remain one of the most prominent causes of protocol deviations. Following every amendment, each clinical trial participant is asked to review the protocol changes and re-consent to the trial. Dealing with paper consent documents can understandably become a frustrating and time-consuming undertaking for participants. They will likely need to re-read the informed consent form (ICF) in full. When they do, the changes detailed in protocol amendments might still be missed or misunderstood, leaving them with a lack of critical understanding or awareness of what the changes entail. This could, in turn, cause participants to not fully complete required trial actions or to drop out.
For example, many protocol deviations noted during inspections and audits arise from the patient consent process, such as:
• Signatures and dates missing from re-consent ICFs
• Incorrect versions of ICF documents used for reconsent or new patient consents
• Participant re-consent not being collected prior to receiving ongoing treatment or procedures
• Lost or damaged paper re-consent ICFs
The solution: implementing eConsent
Through eConsent, and with the support of experienced experts, when protocol amendments are introduced, patients are only presented with the sections of the electronic informed consent form (eICF) that have been updated, saving them time while mitigating the risk of miscommunication or poor comprehension.
Furthermore, participants could have the option of completing the re-consent process remotely, rather than commuting to the trial site to complete a paper copy. The eConsent system also ensures that all required fields and signatures have been completed. For participants new to the trial, the eConsent system will present the latest Institutional Review Board (IRB)-approved eICF, which eliminates the risk of a patient completing an invalid version of the eICF.
On the side of the trial site staff, when entering the eConsent platform, they will be presenting with a simple dashboard with features that allow filtering of participants based on who is up to date on their consent forms. As this process occurs, external monitors have real-time access to the status of patients’ consent, a full audit trail of each consent, and which eICF version the trial consent site has active.
Ultimately, looking at the hours spent and the associated costs of managing and reviewing the consenting documents and deviations, and improving patient comprehension and experience, eConsent evidently presents a positive return on investment.
There’s no getting around the fact that deploying a new technology in a complex clinical trial will require a significant time investment. That’s why it’s vital that amended eConsent deployment doesn’t extend that time further and delay any ongoing or new patient visits.
The industry has experienced a marked increase in the quantity of protocol amendments. Previously, an amendment would shut down the eConsent application and sites had to revert to a traditional paper process while waiting for the digitization and IRB/EC approval of the changes. This inevitably caused unnecessary complications for site staff by creating two processes to manage rather than one. But today, it’s vital that eICFs be equipped to remain fully operational even throughout these amendments.
By continuously refining eConsent systems and operational learnings, amended eICFs can be efficiently deployed to eliminate system downtime. New and improved eConsent platforms have been programmed from years of operational learnings that allow the solution to efficiently deploy amended eICFs and eradicate system downtime.
While welcoming change is difficult, digitally enabled clinical trials are the way of the future, and agile, comprehensive eConsent solutions have the ability to help sponsors and trial sites drive improved compliance and patient engagement.
Planning for protocol amendments in the beginning helps ensure well-organized, compliant consenting procedures for patients, sites and study teams globally. As eConsent solutions become increasingly popular among sponsors, it’s likely that eICF IRB approval processes will become the new standard in clinical trial delivery processes rather than a challenge to overcome.
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