Contributed Commentary by Eric Delente 

November 3, 2017 | In 2016, DrugDev’s annual Investigator Survey uncovered the number one reason sites had not used eConsent in their trial—they hadn’t been asked. In fact, over 77% of sites in our survey self-reported that no sponsor or CRO had ever asked them to enroll patients with eConsent.

As the clinical technology ecosystem evolves to catch up with familiar consumer apps, missing out on the benefits of eConsent can be a significant detriment not only to patients, but also to the sponsor’s bottom line. eConsent helps patients understand the trial, set appropriate expectations, and create a more trusting relationship with the site from the beginning. This leads to satisfaction, and ultimately retention. Research shows studies using eConsent can enroll 25% fewer patients to achieve the same patient completion goal. Given how costly it is to recruit (and then lose) consented patients this is an enormous opportunity cost on which sponsors still using paper may be missing out.

While we and other industry experts believe the number of sites using eConsent will continue to grow organically over the coming years due to eConsent’s focus on patient-centricity, it’s important to note there can be no change without adoption.

Informed Patients Are Retained Patients

Studies show patients who better understand the clinical trials process are more likely to complete it (DOI: 10.1371/journal.pone.0058603). Data from a 2013 CISCRP study suggest that 18% to 30% of patients in a trial will drop out, with 8% of disenrollment due to informed consent errors. For sites and sponsors, this means the informed consent process is their best chance at ensuring patients don’t leave either part way through, or even pre-trial.

eConsent improves retention by offering sites and sponsors a simple tool that focuses on meeting the specific needs of each patient during the consent process. With eConsent, patients are first shown videos that explain the concept of informed consent and the basics of a clinical trial. They then move through each section of the electronic consent form at their own pace. Capabilities such as large fonts and narration help patients with specific needs (e.g. blindness, arthritis, etc.) participate in the trial.

Perhaps most importantly, rather than flipping through a large paper document and signing at the bottom, patients must acknowledge they understand each section before moving on or mark sections they don’t understand for follow-up discussions with qualified medical professionals at the site. Embedded in the process are pop-up glossary terms, additional videos, animations, and quizzes that are used to explain difficult concepts and help patients of all ages, cultures, languages, and education levels retain trial information regardless of their personal exposure to technology.

The result is a system that is flexible, easy to understand, and ensures each patient finishes the consent process informed and with all questions answered. Not surprisingly, patients who complete the eConsent process expressed more satisfaction than those who used traditional paper consent forms (DOI: 10.1016/j.ijmedinf.2013.04.008). This is important because satisfaction has a direct impact on patient retention.

As mentioned previously, a report measured the enrollment rates of two identical trials, one using eConsent and one using paper. The study found simply using eConsent instead of paper meant sites would have to enroll 25% fewer patients to reach the same goal of patients completing the study, which would deliver significant time and cost benefits on a global trial scale.

Addressing Patients Worldwide

With eConsent, sites and sponsors can customize any part of the consent process information to meet the needs of their patients, no matter how niche. For instance, users can switch the voice actors in their audio narrations as needed, allowing them to speak to patients using their local dialect and accent.

eConsent also can be used to tackle regional differences in healthcare culture. For example, certain regional populations may be more reticent when making healthcare decisions. Often, these patients will not communicate if they have questions or understand complex issues. They complete the enrollment process only to drop out later. eConsent offers solutions to this problem. Sponsors can tailor introductory videos, spoken materials, or interactive quizzes to stress that patients should have questions for their investigators, putting their concerns at ease.

Similarly, introductory eConsent videos can be used to explain how the system keeps patient information safe when transmitting it electronically, which is a common concern globally, especially in Europe. These and other features ensure eConsent can be used to educate patients worldwide in a way paper never could.

Monitoring

eConsent offers sponsors and CROs conducting multiple studies the ability to track and monitor the progress of sites during enrollment. Sponsors/CROs can view how far along their sites are in the enrollment process, ensuring sites are meeting timelines. They also can ensure patients are consenting to the correct documents and amendments in cases where multiple consent forms exist, or where additional addendums are required.

Learn and Adapt

One of eConsent’s great advantages is its ability to “learn” from the needs of its patients. The system does so by keeping track of almost every action taken in the system. Study teams can then use this information to analyze their eConsent program and make changes as necessary.

For example, when patients take longer to read through a section, users should look to see where they can improve readability. If patients continually flag a section as “misunderstood” sponsors should see if the section can be re-written. Doing so allows sponsors to continually learn from their patients, improving the consent process with each refinement.

Occasionally sponsors, CROs and sites will conduct studies that extend beyond the typical consenting process. Perhaps there are multiple consent forms a local IRB has required. Or, perhaps sites must collect various biological samples, and their accompanying consent forms. For scenarios like this, eConsent offers a simple solution.

eConsent’s document control options allow it to simultaneously receive and manage multiple consent forms for trials that require them. The document control methods automatically file and index multiple consent forms per patient, making them easy to manage. In addition, eConsent has the flexibility to scan and document any necessary attachments such as biological samples, indexing them as well.

If your study team isn’t using eConsent, it’s time to ask why.

Eric Delente is DrugDev President of Patient Solutions. He can be reached at eric.delente@drugdev.com.

Editor's note: Eric Delente will be moderating a panel of speakers on eConsent at next year's Summit for Clinical Ops Executives--SCOPE--in Orlando, Florida in February 2018. Learn more at www.scopesummit.com