eConsent has developed a reputation for being the next big technological innovation in clinical trials, and adoption efforts are accelerating.
Numerous industry surveys have shown that most of the top 50 Pharma companies are engaged or planning an eConsent initiative in the near future, with many of them already having an eConsent strategy in place.
Technology advances have made eConsent implementation much easier. For example, newer SaaS-based applications that leverage integration with the IRB review now can be implemented rapidly, and at a much lower cost.
Sponsors who love their paper-based processes have complained that solutions like eConsent are too expensive, but the cost of adding eConsent to a study is more than recouped through enhanced study start-up time, reduced monitoring visits, and better subject retention.
All the same, many sponsor efforts are still in pilot phase, said Neetu Pundir, who manages product strategy for CRF Health’s electronic consent offering, TrialConsent.
“This industry is very conservative and cautious, and a lot of organizations have wanted to do a pilot before rolling this out,” said Pundir. “But as sponsors of all sizes and types are beginning to finish their pilots now, we’re seeing them go right into adoption.”
Pundir says she’s seeing a paradigm shift as sponsors now move away from using paper processes in one of the last areas where they had clung to paper. Now, she says, there may be a bit more of a delay as sponsors formalize their efforts around eConsent, adding staff familiar with eConsent, or training staff they already have. But for the most part, she said, their resistance to it is gone.
The fact that it took so long for sponsors to accept it hasn’t surprised Susan Vallow, vice president of Electronic Clinical Outcome Assessments (eCOA) Solutions for MedAvante-ProPhase, who has worked in eCOA for 20 years, and watched it take almost that long for sponsors to get comfortable with paperless processes in other realms of clinical research, like clinical report forms.
Sites also are more open to adopting eConsent now, as the technology behind it has gotten more streamlined, and is easier to use, as opposed to just another complicated thing sponsors want sites to come up to speed on.
Plus, the new eConsent solutions also have version control imbedded in them, said Vallow, so sites no longer have to hunt around for the multiple versions of an eConsent document. Instead, all versions are accessible, having been tracked electronically.
So what’s keeping all sponsors from adopting eConsent? Some countries, including China and Germany, don’t allow eSignatures, which are a key part of eConsent. Many other countries have laws around eSignatures that are vague enough to spook sponsors.
With virtual trials — otherwise known as direct-to-patient trials — beginning to enter the marketplace, eConsent will only become more prominent.