The Digital Medicine Society (DiMe), an interdisciplinary professional society for digital medicine, was able to deploy Medrio’s eConsent module in less than two weeks to support its remote study to assess nocturnal scratching as an endpoint for patients with atopic dermatitis. The multiphase study is part of an ongoing pre-competitive collaboration with leading pharmaceutical companies, including AbbVie, Janssen, Novartis, Pfizer, and UCB, facilitated by DiMe.
“The aim is to generate reliable scientific evidence that drugmakers, medical device companies, researchers and others can use to develop new digital measurements aiding the research and care for people with eczema,” said DiMe CEO Jennifer Goldsack. “Greater standardization among measures could make it less costly to develop new therapies and get them on the market faster.”
In line with its mission to advance the ethical, effective, equitable, and safe use of digital medicine to help redefine healthcare and improve the lives of people, DiMe sought to ensure that all participants in the mixed methods study would be consented correctly. It was critical that all patients received and understood all required information and that their safety and privacy would be maintained.
It was also important for the team to explore moving on from paper consent to a more flexible, secure, and remote eConsent solution. Paper can be lost or destroyed, and not having those records can cause a lot of problems. As DiMe executed the study completely remotely, they needed the consent process to be easy and comfortable for the patients. In the end, the participants were able to provide their consent from the comfort of their homes, and the study managers were able to keep the electronic records.
Compliance was another need, and the DiMe team was interested in the compliance benefits that could be delivered by a strong eConsent partner. With electronic consent and associated electronic documentation tools, DiMe had an audit trail and knew exactly what was sent when, to whom, when they signed it, when they returned it, and if they sent them back a copy. “This level of certainty is one of the biggest upsides of electronic collection,” said Lucia Cesnakova, DiMe Program Lead. “If audited, there’s confidence in that clarity and documentation.”
After reviewing several potential eConsent solutions, DiMe selected Medrio’s eConsent module because of its ease of use, backed by Medrio’s extensive implementation support. “It was very easy to use Medrio’s system. In less than two weeks, and after just a couple of calls with the Medrio implementation manager, I felt comfortable creating and deploying eConsent on my own. It was very quick.” shared Cesnakova.
DiMe was also impressed by the flexibility of the Medrio platform.“ What stood out was that, even though the Medrio system has a lot of features and can serve complex studies, we could still single out just the features we need–in this case, eConsent–without sacrificing quality or service,” Cesnakova said. “There was no pressure to buy a package full of features that we didn’t need.”
In addition to meeting DiMe’s need for an effective consenting solution, Medrio’s eConsent approach offered a secondary benefit, as it helped DiME to expand and accelerate participant recruitment. For recruiting, DiMe has worked with several patient organizations focused on eczema. Because consent was all electronic, participants simply signed up on the study website, and study managers could then follow up quickly – in many cases the very next day – with the consent materials. With a paper process or another more manual solution, that wouldn’t be possible.