Applied Clinical Trials
Debunking the six most common myths regarding electronic informed consent.
The average human swallows six spiders over the course of their lifetime. Gum takes an average of seven years to digest, and electronic informed patient consent isn’t permitted in a variety of countries. What do all three of these things have in common? They’re all myths.
The first two are harmless and are easily debunked by a quick Google search. The third however, has the potential to negatively impact a patient, a site, or a clinical trial. Here’s a quick list debunking six of the most common myths we’ve heard regarding electronic informed consent.
1.Myth: Electronic Informed Consent Isn’t Widely Adopted
Opponents of electronic informed consent are quick to state that only a few companies are using it. Fortunately for patients, that’s not true. In fact, a 2014 WIRB Copernicus Group study showed that over 66% of the top-50 pharma companies had tried electronic informed consent back in 2014, with 100% of the top 10 piloting it as well.
Some large pharma have chosen to switch entirely to electronic patient consent for all future trials. At DrugDev, an IQVIA company, we’re well past our 100th electronic informed consent trial across 50 countries and 30 sponsors, and we project higher numbers of electronic informed consent studies for 2018.
2.Myth: Many Countries Don’t Support It
Another commonly purported fact is many countries don’t allow the use of electronic informed consent. Once again, this statement is false. It’s important to note there is no regulation from any country currently that prohibits the use of electronic informed consent.
There is regulation in select countries that prohibits the use of electronic signatures. Fortunately, these regulations don’t affect the use of electronic informed consent, because paper signatures can be easily scanned and uploaded into a clinical operations system for documentation and audit purposes. This approach can allow use of electronic informed consent worldwide without issue.
3.Myth: Sites Dislike It
Another myth we hear from time to time is sites dislike electronic informed consent. Based on our own site survey data, this couldn’t be further from the truth.
In fact, sites love electronic informed consent because it helps sites and patients focus on concepts or issues with which they’re having trouble, which improves the quality of conversations and questions during the consent process. Sites have also reported they appreciate the reduction of paperwork, the ability to provide patients with a multimedia eICF for viewing at home, and the convenience/quality of life dashboards and reports provide.
4.Myth: It’s Too Difficult for Seniors
This myth tries to appeal to common stereotypes regarding seniors and technology, but has been proven wrong by multiple studies. In a 2016 study conducted by Janssen, seniors “universally reported high satisfaction on each eConsent feature, finding the process ‘easy’ or ‘very easy.’”
In a 2013 National Center for Biotechnology study, 80% of 160 women age 65 or older were “able to complete all screening questions consistently and showed a nonsignificant trend towards greater ease of use and willingness to spend more time in their physician's office compared to those using IVRS.” The study concluded the women “found good satisfaction and feasibility with a tablet computer interface for the recruitment and screening of patients for a hypothetical osteoporosis PCT in community office settings.”
5.Myth: It’s Too Expensive for Most Studies
While there are certainly costs associated with a full-service electronic informed consent model, these costs are mostly overreported. In many instances, sponsors reporting high costs for electronic informed consent are reporting the combined costs of using paper and electronic informed consent at the same time, and as separate processes.
For most studies, the costs of electronic informed consent are comparable to managing the costs of a paper consent process. Added to that, current costs are expected to plummet with “build it yourself” SaaS models.
6.Myth: Electronic Informed Takes a lot Longer than Paper
Once again, the myth that electronic informed consent takes longer than paper consent is simply not true. Those who say that the paper process is quicker may not be accounting for the total amount of time saved across the entire informed consent process.
Both sites and sponsors have reported an increased time savings when using electronic informed consent due to its ability to…
· author ICFs,
· manage approval chains for documents,
· employ workflow management controls,
· directly integrate with IxRS, CTMS, and eTMF systems, and
· automate the audit process through system-wide tracking and creation of all audit documents.
Eric Delente, President, DrugDev Patient Consent, email@example.com