Eric Delente

	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

. 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. 

2. Myth: Many countries don’t support It. 

This 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.

Based on our own site survey data, sites disliking electronic informed consent 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. 

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 toward 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.”

	While there are certainly costs associated with a full-service electronic informed consent model, these costs are mostly over reported. 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. 

6. Myth: Electronic informed consent takes a lot longer than paper.

 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.

Articles

Debunking the six most common myths regarding electronic informed consent.

MythBusting: 6 eConsent Myths we Need to Correct in 2018

	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.

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 100

 electronic informed consent trial across 50 countries and 30 sponsors, and we project higher numbers of electronic informed consent studies for 2018.

	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.

	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.

	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.”

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 

electronic informed consent at the same time, and as 

	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.

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…

	·       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.

	Informed consent is a fundamental principle of healthcare research. It explains to the patient the goal of the study, their role as a subject of research, the risks involved, and what they should expect if they decide to participate. According to FDA guidance, sponsors and physicians must provide patients with adequate information to make an informed decision, facilitate patient comprehension and provide adequate opportunity for the subject to ask questions.
	
	Historically the focus has been on getting the consent signed rather than on making sure the patient understands the information in the informed consent form (ICF). The Industry has not done an excellent job of informing patients of what participation in a trial means, as evidenced by the high dropout rate. In a recent CISCRP survey 35% of patients who dropped out of a study reported that they felt the consent document was difficult to understand.
	
	Paper consent often is a weighty document, sometimes over 30 pages long, and full of medical terms and legalese most patients don’t understand. Additional studies suggest that patients who are presented with eConsent significantly improve understanding of the trial, and this is correlated with a higher observed patient retention rate. Keeping patients engaged and informed can have a dramatic impact on their overall experience.
	
	Electronic informed consent, or eConsent, improves the consent process based on several proven educational methods. It incorporates combinations of video and audio narration, features illustrated popup glossary terms, organizes ideas in digestible “chunks” (progressive disclosure), enables patients to highlight areas they have questions about for discussions with sites, and provides opportunities for interactive quizzes to reinforce ideas and test for comprehension along the way.
	
	eConsent tracks the patient review process so physicians/coordinators can identify where patients are having trouble in the document and what needs to be discussed in more detail. This stimulates more meaningful conversations between the physician and patient and can help reduce the patient’s anxiety and reluctance. eConsent can be easily adapted for hearing or vision impairment, children, language differences or other special needs.  For example, the font size of the text can be easily adjusted, or a video can be created to optimally engage various demographic profiles.
	
	In its 2016 Annual Global Site Survey, DrugDev queried 418 sites worldwide on site-facing technology adoption. 72% of sites surveyed had no experience with eConsent, yet at least 50% agreed eConsent would decrease site burden and be easier to use than the paper version by offering improved version control, a better dialog with the patients, and better patient comprehension.
	
	In the survey, 77% of the sites reported they are not using eConsent simply because they have not been asked by the sponsor. It is clear sites are open to using the technology but need more education and a better understanding of the process as they would with any new technology or system.
	
	So why aren’t more sponsors and CROs using eConsent? Do they fear sites won’t like it? That it may take too much time? Or is it because they don’t want to introduce yet another system and yet another login?
	 
	Like any new technology, the time required to switch to an eConsent program isn’t trivial, but the long-term rewards far outweigh this initial effort. While many sites still use multiple EDC systems that require multiple log-ins, the industry is seeing unified clinical trial systems that streamline clinical operations and reduce the logins required to run a trial.
	
	It wasn’t that long ago when EDC was introduced and naysayers felt it would never be adopted. Now the majority of sites are using EDC to capture and share trial data. Adoption of eConsent can and will occur if sponsors and CROs want faster enrollment and improved patient satisfaction and retention. eConsent manages the patient consent process using technology and devices patients already use in their daily lives. It enables real-time tracking and data management, and helps patients and investigators make fully informed, thoughtful and appropriate decisions for their treatment.
	
	

, President of Patient Engagement, DrugDev. eric.delente@drugdev.com

Adopting eConsent provides patients with adequate information on studies they may choose to participate in, and thus improving the rate of patient satisfaction and retention.

Eric Delente

Articles

MythBusting: 6 eConsent Myths we Need to Correct in 2018

MythBusting: 6 eConsent Myths we Need to Correct in 2018

Improve Patient Comprehension and Retention with eConsent