Informed consent has been the backbone of ethical clinical trials for the last 70 years. It is central to modern clinical research, and yet it is also one of the industry’s last paper processes. Despite this, many have talked about why it makes sense to collect and manage consent electronically, when regulations allow. It’s fairly low-risk, especially given advancements in digital technology, analogous products like DocuSign and widespread use of digital tools. And it makes intuitive sense to integrate eConsent into an existing technology tool that sponsors and sites are already using, rather than creating a new system for a relatively straightforward process. Looking across all the systems that sponsors and sites need to use to manage their clinical trials, from Suvoda’s vantage point, eConsent belongs integrated within the IRT system. And it’s not just because we also make IRT.
Here’s why we think eConsent and IRT are better together:
If the patient journey is the alphabet, eConsent is ABC to IRT’s DEFG.
A patient’s experience with a clinical trial starts with consent. Once the patient is consented, they are immediately screened for eligibility and, if eligible, randomized into a treatment arm.
The IRT system already manages screening and randomization, so from a technical standpoint, it’s “easy” for IRT to pick up its work at step 1 in the patient journey, instead of step 2. From a human standpoint, it just makes sense to keep the patient’s earliest interactions managed by one system.
Integrating eConsent into IRT can reduce mistakes
No one wants to make mistakes around consent. But they do happen. From 2009-2021, nearly 500 clinical trials have been cited for mistakes in the consent process*: not a huge number, but not great, given our industry’s history with patient protections.
With eConsent and IRT integrated together, the system provides a helpful check against common mistakes: the IRT will not allow patients to be screened, randomized or receive treatment if they have not signed the most current consent form. In studies with multiple protocol amendments, each requiring re-consent, this becomes even more important.
Integrating eConsent into IRT creates a digital record
Today’s paper consent process means manual labor and time to manage paper records. Record-keeping may not be sexy, but we have to do it. Managing the consent process electronically creates elegant reporting and compliance, with an easily accessible, always up-to-date record of consent and re-consent.
When that record is integrated with records of patient screening, randomization, visits and dosing, it is even more straightforward for sponsors and sites to get the visibility they need.
Artful consent management with an intuitive, easy to use system
Digitizing the consent management process, and integrating it with the IRT system, provides sponsors, CROs and sites improved visibility and automated control throughout the early and medium stages of the patient journey. And, it’s not just one more thing an overworked clinician or study manager has to manage; it’s easy, especially when integrated into an intuitive, easy-to-use system that is already part of the study.
The risks are low, and the rewards are high: Making the consent process simpler for sites and sponsors. Ensuring real-time visibility to consent status. Ensuring no patients accidentally receive the wrong treatments because of a misstep in the consent or re-consent process. Making consent more informative and easier for patients.
*US Food and Drug Administration. Data Dashboard. https://datadashboard.fda.gov/ora/cd/inspections.htm Accessed 5.13.2022.