The Benefits of eConsent Forms for Clinical Trials
by Andrea Bastek, PhD, Director of Innovation at Florence and Former Senior Field Clinical Engineer at Abbott
75% of research sites either have some form of eConsent or want to adopt an eConsent platform in the future. But as sites learn about electronic consent and upgrade to better software, research staff have begun to wonder about the return on investment (ROI) of eConsent.
Although eConsent software requires an initial investment from sponsors and sites, your research organization will see a substantial return on investment. This ROI comes from saving time on paperwork, avoiding compliance errors, reducing loss-to-follow-up, and enrolling more participants.
We’ve put together this breakdown to help you see how your organization can get a strong ROI from eConsent:
Save Time on Paperwork
Anyone who’s helped with the consent process for a clinical trial knows how much time you have to spend dealing with paper forms. To start, you need to make sure you have the latest version of the Informed Consent Form (ICF) for each study.
Ensure You Have the Latest ICF
It might seem like a good idea to make many copies of the informed consent form at the beginning of the study, so it’s easy to grab one any time a patient comes for a consent visit. However, research veterans know this could lead to staff accidentally using an outdated version of the ICF, which would create even more paperwork.
Your research site would then have to report the deviations to the sponsor and IRB, add notes to your study files about why the error occurred, and create remediation plans for how to prevent the mistake from happening again. Because of this, clinical research coordinators have to confirm they have the latest version of an ICF each time they go to a consent visit.
But working on more than one trial at a time and slow patient recruitment rates make it hard to track when every consent form has been updated. Research staff often spend time emailing their regulatory coordinator or checking their IRB portal before they can even print out the consent form.
eConsent eliminates this extra step and helps reduce potential compliance risks. Whenever a member of your organization updates an ICF, they can upload the newest version to your eConsent software and make it active for immediate use.
This should also deactivate all “copies” of any prior versions of the form to ensure no old versions are accidentally signed. Then any clinical user or participant who logs into the system will see the correct version of the form on their phone, computer, or tablet.
Manage Additional Forms
Coordinators also need to determine what other forms participants should complete and sign at the consent visit. Is there a worksheet or questionnaire that has to be filled out? Missing data points in the medical history you need to ask about? What about optional sub-studies or specimen collection forms that must be discussed? Or a separate HIPAA form?
This information might be found on a study checklist or in the protocol. Without eConsent software, you’ll have to look up what forms are needed. Then you might need to print or copy all of the forms, add highlights or “Sign Here” sticky notes so participants can understand them, and physically take the documents to the participant along with the ICF.
eConsent eliminates many of these steps. Your team can upload all additional forms under the correct study in the eConsent platform. You can set these forms to automatically go out to all new participants when they are invited to the study, or you can send the forms manually if they only apply to select participants.
The correct forms will go straight to a participant’s device. When the participant signs, their eSignature will automatically appear on the correct line. This will save you time, give you better oversight of the study’s progress, and ultimately lead to a strong ROI for your eConsent software.
File Forms Quickly and Accurately
Once the participant has signed paper informed consent documents, research staff must copy the signed forms and give copies to the participant. Even this can take time. (Is there a copy machine close to where the consent occurred? Is the staff member allowed to use that machine? What if there’s a paper jam or the copier is out of paper?)
Once the copying is over, staff members then have to file the paper consent forms in all of the right places. Depending on your site, this might mean scanning the form and uploading it to the EMR, the CTMS, or the electronic patient binder. It could also mean physically filing the form in the correct binder in a storage room.
If the Informed Consent Form requires updates during the study, you’ll then need to dig through paper binders, spreadsheets, or multiple electronic systems to figure out which participants need to re-consent.
But eConsent can help. When a participant is done signing, the signed form will go straight into your eConsent system. The software will also clearly track form versions so you can quickly see which version of the form each participant has signed.
Finally, a good eConsent platform will offer flexibility to accommodate your workflows and Standard Operating Procedures (SOPs). You want software that your team can use efficiently and compliantly at your site.
Cut Down on Paperwork for Monitoring Visits, Audits, and Inspections
eConsent software doesn’t just help sites with completing consent forms. As the study progresses, eConsent can also cut down on the time and paperwork required to prepare for monitoring visits, audits, and inspections.
With eConsent, you’ll no longer need to pull participant binders or spend a long time finding signed consent forms, making sure all of the latest versions have been used, and checking the completion and accuracy of signatures, initials, and dates.
The eConsent system will have all forms stored in one program, and you can quickly check to see which version has been used. You’ll also know that signatures, initials and dates are complete and appear in the correct locations. Unlike paper forms, eConsent software can refuse to accept incomplete forms and ensure signatures appear where they belong.
These features greatly reduce the risk of compliance errors from missing, incomplete, outdated, or inaccurate consent forms. This, in turn, means you’ll have to spend less time on follow-up requests after monitoring visits.
See Overall Time Savings
Based on our conversations with research sites, we estimate that eConsent will save one hour of paperwork time and one hour of preparing for monitoring visits per consent. This includes time spent finding the correct forms, printing forms, showing patients where to sign, copying signed documents, and filing completed forms. These time savings will reduce overall study cost and lead to a substantial ROI.
Reduce Participant Loss-to-Follow-Up
Patients becoming lost to follow-up (LTFU) can slow down clinical trials or even invalidate their results. The impact of LTFU participants depends on the protocol design and the statistical analysis plan for the data. But if too many participants drop out, it can lead to consequences like:
1) the trial needing to recruit more patients
2) the statistical significance of the study results being put at risk due to inadequate data
3) assumptions that participants who dropped out may have experienced the worst outcome, which can also affect the statistical significance of the trial data
Each of these consequences could delay the study or prevent approval of the study drug or device being tested.
Participants becoming lost-to-follow-up can also impact study site performance and revenue. Sponsors may look at LTFU rates during site selection to determine how well a site recruits and retains participants, especially since loss-to-follow-up generally hovers between 14% and 30%.
What Does eConsent Have to Do with LTFU?
So how can eConsent help? Participants who are well-informed during the consent process may be less likely to become LTFU. A 2013 survey found that 35% of participants who dropped out of studies didn’t understand the consent form, versus only 16% of participants who remained in the study.
This means that about 20% of LTFU participants might remain in clinical trials if they experienced a better consent process. All together, this could increase patient retention by 4%-6% (20% of the 14-30% of LTFU participants).
Increase ROI with Lower LTFU
A 4-6% increase in retention may sound small, but the average clinical trial now costs between $12.2 million and $33.1 million. Reducing trial duration or improving the statistical outcome of a study by a small amount can save sponsors $500,000-$2 million.
Sites could also see a strong ROI from retaining more patients. For example, say a LTFU participant drops out roughly halfway through the study. All of the time spent on screening and enrolling that patient is wasted. The site will also receive revenue from 50% fewer study visits.
Gaining 50% more study visits for 4-6% of the participant pool may not seem like much. But visit revenue from the latter half of a study often requires less staff effort. The staff have conducted the time-consuming screening, recruitment, and consent processes, and the participant is already engaged in the study and knows what to expect at each visit. That means that these visits are low-workload and are more profitable for the site.
People not dropping out also provides more endpoint data, which improves the integrity of the trial. Ideally, drop-out rates need to stay below 5% to ensure the FDA or other regulatory bodies will accept the data for review.
Improve Participant Enrollment
Implementing eConsent can result in increased enrollment for sites. eConsent removes geographic barriers for participants who live far away from a study site, as 70% of people do. Participants can consent from their homes or their local doctor’s office instead of driving a long distance and then navigating a sprawling hospital campus.
Why eConsent Helps Patients
eConsent became vital during COVID, when family members couldn’t come to the hospital and research staff were often working off-site. But reducing the number of study visits and drawing in local pharmacies and doctor’s offices can increase recruitment long after the pandemic is over.
The costs of transportation, food, parking, hotel stays, and time off for in-person consent visits can be substantial, especially for low-income families. The option to consent from home or from a satellite site could draw in older patients, patients with mobility-related disabilities, patients who don’t have a car, and patients who can’t afford to take time off work.
This flexibility is why patient-centric tools like eConsent can reduce recruitment times by 42%, which could lead to a large ROI.
Help Participants Understand Informed Consent
89% of participants who completed a clinical trial felt that their questions about informed consent were answered. By contrast, only 64% of patients who dropped out of trials felt their informed consent questions were answered.
These statistics indicate that participants are far more likely to stay in trials when they fully understand the informed consent process. Good Clinical Practice regulations state that consent forms must be written in an understandable way, and IRBs enforce reading level limits for the content. However, the forms can still be difficult for patients who have learning disabilities, who are visually impaired, or who speak English as a second language.
Informed consent documents can also be long, stretching from 15-20 pages on average. Allowing participants to review this information in their own space and time and to share it with loved ones reduces the stress that often leads people to decline a study.
Ultimate Benefits of eConsent
When combined with reduced travel, these benefits can increase enrollment because they make it easier for patients to say “yes” in a relaxed environment. Faster enrollment will lead to greater revenue and greater ROI for your site’s eConsent platform.
How to Find an eConsent Platform with Strong ROI
To achieve an impressive ROI on your eConsent software, you need an easy-to-use platform that will cut down on time-consuming tasks like printing, copying, and scanning. eConsent software can also decrease lost-to-follow-up rates and speed up recruitment by providing a more patient-friendly experience.
eConsent is a relatively new technology, and most platforms will continue to add features in the coming years. But if your site is purchasing eConsent now, your top priorities should be ensuring that the software speeds up your current workflows, meets the requirements of your sponsor and IRB, and improves the clinical trial experience for your participants. You can learn more about essential eConsent features, including the features that Florence’s eConsent software offers, by checking out our product tour or viewing our eConsent checklist.
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