By Andrés Escallón, Vice President, eClinical Innovation at Suvoda

Healthcare technologies hold incredible promise: for new therapies, elevating the standard of care, and for ensuring privacy and accuracy for patients. They also help manage the increasing complexity within the healthcare sector, so that doctors, nurses, and others can focus on the patient.

At least they are meant to control complexity. But if not done well, technology can actually draw attention toward the system itself and away from the patient or the treatment. This is especially true in clinical trials, where each study may have five to seven different technology solutions to manage various steps in the process.

Informed consent is one such step in the process, and arguably the most important, as it ensures each study participant has made an educated decision to participate or remain in a clinical trial. Historically, this has appeared straightforward and simple enough to be managed manually. As such, it has remained one of the last paper processes in today’s clinical trials. But, as global studies become more complicated due to increased regulations, decentralization, fast-moving therapy advancements, and more, this seemingly simple step is no longer simple, and is surfacing as a process that can significantly impact trial integrity, participation levels, timelines and budget. These implications make the consent process ripe for automation.

The truth is, applying today’s technology to consent is fairly low-risk, especially given advancements in digital technologies like DocuSign, which have seen widespread adoption. If done well, digital consent management, or eConsent, can provide sponsors and CROs real-time visibility and control over the consent process throughout the life of the study, regardless of how many times participants must be re-consented.

But, the likely question is, can we incorporate digital consent technology to a clinical trial without disrupting existing processes or adding more work for site staff?

The answer is actually “yes.” There are technologies today that enable site staff to create a digital version of consent while in the flow of work – enabling real-time visibility into consent without disrupting any existing processes. And, when that simplified digital consent process is integrated with the trial IRT system, that data is easily accessed within a platform that is already being used each and every day by the study team to ensure the right drug is reaching the right patient at the right time. This approach moves trial teams away from focusing on technology and toward improving the patient experience.

Let’s dig a little deeper into why eConsent and IRT are better together.

If the patient journey is the alphabet, eConsent is ABC to IRT’s DEFG.

The patient journey through a clinical trial can be arduous. For patients who’ve struggled with ill health, often for years, it can feel like another step in a Sisyphean quest for a better quality of life.

Clinical trial technology should make it easier for the study team to manage the patient journey — and putting eConsent together with IRT can do that. Consent is of course the first part of any trial. Before a patient can be screened for eligibility, randomized into a treatment arm or receive any experimental medication, they must consent to participate in the trial. If consent is a patient’s step one, step two is screening and step three is randomization.

From a technology perspective, the IRT system already handles patient screening and randomization, visit management and dose dispensation once the patient starts actively participating in the trial. With eConsent integrated into IRT, the IRT system just picks up its work a little earlier in the patient journey — simplifying the technology experience for the investigators and study managers using trial systems every day.

Integrating eConsent into IRT can reduce mistakes

An integrated eConsent and IRT system can further support patient centricity by reducing errors and freeing up trial sponsors, CROs, and clinicians to focus on care and treatment, rather than managing the consent process.

As much as everyone works to avoid mistakes around consent — like ensuring that patients understand what they’re signing up for and that no patients start participating in a trial before they’ve consented — mistakes do happen. From 2009-2021, nearly 500 clinical trials were cited for errors in the consent process.[1] While it may not sound like an exorbitant number, given our industry’s history with patient protection, it’s far more than there should have been.

Integrating eConsent within IRT provides a helpful double check for clinicians: the system includes hard stops so that no patient can move on to the next process before all other required processes are complete. That means patients cannot be inadvertently screened or randomized within the IRT system unless they have reviewed and signed the most up-to-date consent form.

 Simplifying re-consent

Informed consent is not a document, it’s a process, and  with the ongoing change and protocol amendments in today’s clinical trials, the re-consenting process cannot be ignored.

Oncology trials, for example, have on average 5 protocol amendments per trial, each requiring patients to re-consent to participate.[2] Other therapeutic areas can be less complicated, but still often require multiple rounds of consent. Each time a patient needs to re-consent, the study team runs the risk of delays or compliance issues if that patient misses their re-consent or is inadvertently given treatment before signing the amended consent forms.

With IRT already managing drug dispensation and visit schedules, integrating re-consent into the IRT system simplifies the re-consent process to ensure that patient consent is up to date and systematically documented in the event of protocol amendments.

If eConsent + IRT together can simplify the re-consent process, why not do it?

Elegant 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 control throughout the early and middle stages of the patient journey. There are all sorts of technical reasons why IRT is set up to handle a process like eConsent: for example, IRT handles thousands of system transactions each day, and eConsent is just one more transaction.

Most important are the human reasons: Making the consent process simpler for sites and sponsors,  ensuring sites and sponsors have near real-time visibility to consent status, and ensuring no patients accidentally receive the wrong treatments because of a misstep in the consent or re-consent process. Simply put, together, eConsent and IRT make consent more informative and easier for patients, allowing them to focus their energy on the trial and their health.

About the Author:

Andrés Escallón is Vice President of eClinical Innovation at Suvoda, a global clinical trial technology company that specializes in complex studies in therapeutic areas such as oncology, central nervous system (CNS), and rare disease. Andrés is a career eClinical services professional having spent over 15 years in the clinical trial industry.

[1] US Food and Drug Administration. Data Dashboard. https://datadashboard.fda.gov/ora/cd/inspections.htm Accessed 5.13.2022.

[2] Getz, Kenneth. Doubling Down on Protocol Amendments and Deviations. Pharmaceutical Outsourcing. March 1, 2022.  Accessed 5.13.2022.