Informed Consent Goes Digital

By Ann Neuer

August 29, 2013 | Electronic solutions have become a mainstay in clinical trials, yet one critical aspect, the informed consent process, has stubbornly remained paper-based. And that’s about to change.

In an industry-wide effort to make clinical trials more patient-centric, sponsors are beginning to look at the informed consent process as more than a dry but mandatory paper document that describes the study protocol in all its complexities to potential study volunteers. Driven by a desire to streamline clinical trials, meet strict timelines, and embrace suggestions from an Institute of Medicine report on improving clinical trial quality through a more patient-centric view, sponsors are poised for meaningful change.

At the same time, input from the Food and Drug Administration is spurring interest in a better informed consent process. In August 2013, a new FDA guidance on risk-based monitoring was released, which states that use of electronic informed consent may facilitate sponsor oversight of human subject protection.

“Pharma seems to be committed to moving toward patient-centricity, patient engagement, patient interaction in earnest. What could be more patient-centric than making sure patients understand informed consent?” says Anthony Costello, CEO of Mytrus, a California-based clinical technology and services company.

Costello explains that understanding the details of a clinical trial is critical to patient engagement, as patients who do not understand a trial are more likely to drop out, a factor that wreaks havoc on tight budgets and enrollment deadlines. He adds, “We know from past experience that patients often do not understand consent. For example, they may not realize that a study will require multiple visits or multiple blood draws. Almost every company we talk to has an initiative to make their informed consent more understandable.”

Similarly, Dr. Susan Brink, CEO of Consent Solutions, an internet-based system for informed consent, concurs that pharma is seeking to put the patient in the center of the clinical trial experience, starting with the informed consent form (ICF). And with the rise of the tablet, namely the iPad or the Android tablet, it is possible to complete the process at the site with SecureConsent, an interactive e-consent system that uses multi-media and collects a digital handwritten signature.

According to Dr. Brink, “As part of the informed consent process, we engage people with video and audio. As they see and hear the information, instead of reading a paper form, they begin to understand what the trial will entail. For example, if there will be three visits a week for several months, we put in a link to a calendar that actually displays when the visits will take place.”

She explains further that an interactive medical terminology library is included, so if a potential subject does not know what an MRI is, there would be a picture of the machine and a link that describes it.

To gauge the patient’s understanding of the consent information, a series of screens are set up along with two statements at the bottom of each screen, either “I understand”, or “I have a question.” To advance to the next screen, the patient must select one of the two options. If the patient selects “question”, someone at the site is notified electronically, who then comes in to review the information with the patient and provide a response. All questions must be answered before the patient can sign electronically.

Enroll, the Mytrus solution, also uses an iPad, videos, and other multi-media tools to engage patients and boost their level of comprehension. In addition, there are quiz questions throughout the process, and patients can flag words or paragraphs they don’t understand so site staff can address those issues.

To determine the value of this effort, both SecureConsent and Enroll collect metrics as to how long a patient spent looking at each of the consent screens on the tablet and where they have problems understanding terminology or concepts. Sponsors are able to see which paragraphs are problematic in terms of confusing patients or causing them to decide against participation in the study.

Costello says, “None of this information has existed before, so we are creating a treasure trove of data for sponsors. In the dollars and cents analysis of implementing new clinical technology, these data help sponsors determine their ROI. We have modernized all the pieces of the clinical trial data chain, such as the case report form, EDC, ePRO, and IVRS, but the ICF remains a pile of paper. It’s the last piece of the data chain to go digital, and it’s ready to happen.”