A growing number of electronic consent (eConsent) solutions have appeared on the market, with clinical trial technology provider Suvoda recently joining the list by adding eConsent functionality to its market-leading IRT system.
Yet despite an array of options and the many pertinent benefits of adoption for sponsor, site, and patient, the industry is in no rush to say goodbye to its longstanding paper-based approach. Here, we discuss three common reasons why sponsors are reluctant to adopt eConsent tools.
1. Sponsors have overlooked the risks of poor consent management
Many sponsors would probably confess to not giving consent management all that much consideration. With the consent process often managed entirely by the site or contract research organisation (CRO), it can be a case of ‘out of sight, out of mind’. That is until a mistake occurs that disrupts or delays the trial, such as a ‘missing consent’.
A missing consent includes situations when the patient did not consent, the document they signed was not retained, the patient consented in an incomplete manner, or the patient consented to an incorrect version of the consent form. In these situations, the real drawback is the loss of data, says Andrés Escallón, vice president of eClinical innovation at Suvoda:
“Mistakes in the consent management process tend to nullify all of the data collected for that patient. Depending on the trial, if it’s a low enrollment trial like a rare disease study, that can have significant impacts on the overall study.”
All too often, a sponsor doesn’t become aware of a missing consent until it’s too late: the regulatory review. Should a mistake be found at this stage, sponsors filing a trial in the US risk the impact of an FDA 483, which can potentially delay filings. In researching this issue, Suvoda has discovered similar issues in regions across Europe, too.
According to Escallón, any sponsors who have thus far avoided such a finding can consider themselves lucky. “You don’t want to continue to play roulette with your trial,” he warns. “Those who have experienced this will tell you it was a situation that they would have been happy to avoid, as it added additional work to an already full plate, caused delays, resulted in increased costs and worse, negatively impacted the patient’s experience.”
A term known well throughout the industry, eConsent, has long been considered to be unnecessary. Sponsors would rather take their chances that consent will not become an issue. It’s almost as if the industry has accepted the reality that mistakes are going to occur because it’s a manual process. However, with so many administrative tasks on a trial manager’s to-do list, an eConsent platform just makes sense. Why risk data loss, trial delays, additional regulatory hurdles and obstacles when you don’t have to? eConsent tools enable workflows that prevent a patient from even moving forward in a study to which they haven’t consented. The reporting and regulatory filing process itself is also quicker and easier, though the main benefit is control and visibility from beginning to end.
In a decentralised trial, the administrative challenges increase, and the value of an eConsent tool grows. Getting a paper document reviewed, signed and counter-signed may now involve mailing a form back and forth, or emailing a document for the patient to download, print, and sign at home. By risking administrative errors, the great benefit of a decentralised trial – the possibility to widen access to improve patient diversity and inclusion – is at risk, as well. When an eConsent tool is utilised, it increases the accessibility of participation to the study to a wider group of patients.
“Another benefit of using an eConsent tool for remote consent as opposed to mailing or emailing a paper form around is the security; so we’re not sending out a document that has confidential information about the trial, the sponsor, or the patient,” says Heather Nonnemacher, manager of product readiness for Suvoda. She adds that, “with eConsent, patients and additional signers must log in securely, ensuring sensitive information is handled in the safest way possible.”
2. There are common misconceptions about eConsent
A growing number of sponsors are showing interest in eConsent tools thanks to some of the abovementioned advantages. But widespread misconceptions often act as a stumbling block. One is confusion over who should own the tool (the sponsor, site, or CRO). While sponsors make the decision over whether to use the tool, many different groups within the sponsor have ‘owned’ that decision. Meanwhile, the entire process can be delegated to a CRO, who would use their own tool. This has led to a degree of uncertainty in the industry.
“I also think there’s a misconception that if you’re moving forward with eConsent, you need 100 percent buy-in from all sites and patients,” adds Nonnemacher. “That’s not the case. There is a great deal of flexibility, both at the site level and patient level.” Such flexibility can enable a slower, phased approach for sponsors seeking to test the technology before full implementation. This could be on a study-by-study basis, or even site-by-site.
Greater clarity around the difference between e-signature and eConsent, and how the world’s various ethics bodies view those concepts, is also needed. Many European countries have their own signature laws agnostic of eConsent, and their decision on whether to accept digital signatures will impact how a trial uses the tool.
“eConsent itself is widely accepted but there are still laws that need to be observed and followed in each country,” explains Escallón. “Just because a country adopts eConsent, it doesn’t necessarily mean that e-signature is allowed.” In this event, a sponsor could choose to upload a scanned paper form of the signed consent into the consent tool, which enables the consent to be managed electronically even though the signature itself is made on paper. This is something that Suvoda’s eConsent tool allows so sponsors can begin taking steps forward without feeling they must upend their internal processes or risk implementing technology that is not compliant with regional regulations.
3. Sponsors don’t understand the big-picture benefits
According to Nonnemacher, the true value of eConsent is so much more than the option to have an electronic signature, and there are important reasons to use the tool even if patients sign on paper. “You still have the benefits of managing the consent document, having more real-time visibility into the process, having the gating and control. For example, by utilising an integrated IRT and eConsent platform, a patient cannot be dispensed a drug until they have provided their consent. eConsent is much broader than the ability to sign a document electronically,” she explains. This ability to have access to consent documents at any time, from anywhere means trial managers aren’t surprised by a consent failure during a regulatory review. Instead, a failed consent can be identified quickly and rectified so patient data is not lost, regulators don’t uncover errors, and the trial is not disrupted.
Moreover, with consent management an out-of-sight process for many sponsors, it’s likely they haven’t considered how a patient-first approach could actually benefit the wider trial. “It’s ultimately about inclusion and access as well,” notes Escallón. “It ensures that you have an easier way for patients to access and review their forms, and to ask questions, while also enabling the consent process to take place remotely, reducing visits to sites that may be quite far from the patient’s home.”
Final thoughts
Clinical trial enterprises have often been slow to adopt digital alternatives to traditional systems, and eConsent is no exception. But by holding back, sponsors are missing an opportunity to ease themselves into a more automated, digital consent process that gives them a better real-time view of how their trial is running and enables them to make important, time-sensitive decisions regarding the conduct of their trials. Most critically though, they are missing out on a solution that helps to improve the patient experience and increase access to trials.
