By Deborah Borfitz

April 17, 2019 | For nearly 15 years now, study sponsors have had the option of making the informed consent process a multimedia experience for patients rather than a static paper form to be signed. Clinical research publications have been writing about the virtues of electronic informed consent (eConsent) for years, and the technology is broadly accepted even in the most tightly regulated regions of the world.

Over half of the top 30 industry sponsors now use eConsent for at least some of their trials as clients of IQVIA, which at last count had more than 200 studies launched in over 50 countries using the technology. A growing number in that customer base are transitioning to the self-service Informed Consent Form (ICF) Authoring tool launched last year. “We don’t have an adoption problem,” says Eric Delente, head of patient consent. “We have a delivery problem, and we’re tackling that.”

Ironically, this is not a sign that eConsent is either universally embraced or understood. “A fair number of health authorities and institutional review boards (IRBs) are still not aware of eConsent,” according to Cassandra Smith, associate director of patient engagement strategy for Janssen and external engagement lead on the eConsent workstream of the nonprofit collaborative TransCelerate BioPharma Inc. “The U.S., the U.K., and Canada are well versed in eConsent, but in other regions we sometimes have to go out and have a dialogue about what it is and how it works.”

The ROI is also presumed rather than proven by rigorous comparison studies with the legacy paper process. Previous research indicates misunderstanding the consent form is one reason patients drop out of studies, and that the introduction of eConsent has no negative impact on final recruitment numbers, says Delente. But there has yet to be a randomized, head-to-head study that controls for multiple trial attributes, such as a lot of unpleasant procedures, to make the findings meaningful.

For sponsors interested in adopting eConsent technology, conducting robust comparison studies may be a lesser priority than dealing with operational challenges internally and with sites, investigators and patients, says Smith. Shifting thinking away from paper is “not an easy mountain to move.”

The reasons sponsors choose to make the transition with IQVIA, Delente says, is threefold—“because we have been doing this for so long, have more experience in more countries [than newer-to-market competitors] and gone over hurdles of regulatory acceptance.” Outdated laws and regulations make the eSignature feature a harder—but not insurmountable—sell in some countries, he adds.

The biggest hurdle for sponsors in scaling eConsent across their portfolio is that it is more expensive than using paper—in large part because they continue to use hard-copy ICFs at the same time and as separate processes, says Delente. It’s also why IQVIA’s “build it yourself” SaaS model is so rapidly gaining traction.

Signs of Progress

The multifaceted benefits of eConsent—including the ability to depict uncommon words and concepts with images—make it a sensible choice even in seemingly risky therapeutic areas where patients have cognitive impairments and their legally authorized representative is required to do the consent, says Delente. It is also doable, if a bit more complicated, to introduce eConsent in the middle of a study when most patients have already consented on paper.

The whole point of eConsent is to automate quality control and document management. Common features of eConsent tools include multimedia education, interactive ICF documents, self-testing, electronic signatures, version control and tracking, data and audit trail, and the ability to do system queries. Beyond the expected, Delente says, the ICF Author tool also offers “swipe right” navigation, sections in lieu of pages, readability scores on content and bio-sample attributes—in addition to starter templates for self-authoring.

The bio-sample attributes are notable, given the huge financial hit a company might face when it can’t determine the consent status of tissue, urine and blood samples collected during clinical trials. Patient consent for bio-sample use typically happens after the ICF has been signed, and then the sample gets annotated and someone manually enters the parameters of the permission into a spreadsheet and transposes that information into bio-sample software—an inherently laborious and error-prone process, notes Delente.

Using ICF Author, attributes of bio-samples become properties of consent reports, including when patients signed the consent form and what they agreed to and for what time period, he continues. “The tool automatically tracks everything directly to the bio-sample software, so that when samples come into that biobank sponsors already know what patients have agreed to. They know what they can do with a bio-sample 15 years after the fact… and when a sample needs to be destroyed.” They can also readily see when people who were minors at the time of bio-sample collection have reached the age of majority so they can be re-consented. Everything that transpires resides in one longitudinal record.

Realizing the full benefits of eConsent requires that sponsors adjust surrounding processes, Delente says. This would include integrations with clinical trial management, electronic data capture, interactive voice response and IRB systems, which would allow study sites to more efficiently consent patients and report the metadata elsewhere. “As we move to electronic consent forms we also need to stop thinking in terms of pages because people want to see specific content in the informed consent document, and to view it in the optimal format for their phone, tablet, desktop, or cinema-sized TV screen.”

In some cases, Delente says, IRBs still require consent documents be created in Microsoft Word and get amended via track changes that then must be separately entered in the eConsent tool. Companies using eConsent are also variably “aggressive or passive” in how hard they push sites to adopt the technology, even if consent issues remain a top cause of protocol deviations. Sponsors are not interfering with investigators’ responsibility, as some health authorities have suggested, but “providing their sites with a tool to make the consent process more transparent, more accountable and better documented.”

The “transformational change” necessary to make eConsent the norm is already well underway, Delente adds. Some forward-thinking sponsors are now actively working with their IRBs, ethics committees and health authorities to hasten that day’s arrival.

Guidance and Insights

Besides IQVIA, at least a half dozen other eConsent tools are on the market and they differ primarily in how they engage patients and what and how they report back to sponsors, says Smith. Some systems may also have limitations in cases where electronic signatures are needed.

Many regulators and IRBs the world over still require the submission of both paper and electronic consent forms, Smith says, and this may change with time. Paper documents also remain a fixture at trial sites, since FDA guidance issued in December 2016 expressly permitting eConsent requires that hard copy versions be available to study participants.

For companies still trying to find their way with eConsent, the eConsent assets of TransCelerate are terrific resources, Smith notes. From a sponsor perspective, the eConsent Country Overview may be of greatest interest. The information is based on surveys taken in 2016 and 2018 and provide a “voluntary snapshot” of where and how eConsent has been used at the country level—including which educational components were used, which signature modality was implemented and where eConsent had been submitted or approved.