Notes from the Field: How eConsent Improves Clinical Trials

Author: Tina Caruana, MSc, MBA, Medrio Subject Matter Expert – eClinical Solutions (Digital and Decentralized Trials)

Evolved consent tools benefit participants, sites, CROs, and sponsors

Clinical trial recruitment and retention are critical to study startup and success. Unfortunately, many clinical trials face initial hurdles simply due to a complex informed consent process. Did you know that over two-thirds of sites fail [1] to meet the original patient enrollment goal for a given trial? Or that up to 50% of sites enroll no patients [2] or only a single patient in their studies?

In a previous post, we explored how eConsent can be a valuable tool to improve participant retention in clinical trials (Read here: Need Better Clinical Trial Retention? Start with eConsent). However, the benefits of eConsent are actually multi-faceted. In this blog post, we will explore these advantages as they relate to participants, sites and sponsors/CROs.

Why Participants Prefer eConsent

  • Simplifies the study enrollment experience
  • Reduces the complexity of consent forms
  • Supports participant diversity related to location, finances, or family and work demands
  • Provides flexibility for participants to discuss their consent decision with loved ones, caregivers, or friends
  • Enables easy outreach to site teams, in some cases

Aside from ease of use, there are many patient benefits of implementing eConsent over paper. First, eConsent provides a way to simplify the study enrollment experience. With eConsent, potential participants do not need to travel to a clinical trial site for the sole purpose of signing a consent form. Instead, they can review and electronically sign the consent document wherever they are, from a variety of familiar devices including smartphones, tablets, laptops and desktop computers. This approach enhances convenience while minimizing costs and travel burdens. It also appeals to participant preferences. A recent study published in the Journal of the American Medical Informatics Association [3] revealed that “many participants favored the idea of consenting electronically rather than on paper.”

eConsent solutions that incorporate multimedia elements may also reduce the complexity of consent forms. For example, graphics, videos, quizzes, or other interactive tools can help guide participants through the electronic ICF (eICF). These features support participant comprehension of the study’s purpose and procedures while remaining compliant with consent regulations. In cases where participants have physical or cognitive impairments, the use of such multimedia features is particularly beneficial.

Furthermore, with increased efforts to improve inclusivity and diversity in clinical trials across the research continuum, eConsent is also a helpful tool for making participation easier for individuals who are restricted by geographic location, finances, or family and work demands. Historically, strictly site-based studies have greatly hampered diverse patient groups from engaging in clinical research. As one element of a decentralized or hybrid study approach, eConsent can limit unnecessary visits to the research site by allowing individuals to participate in the consent process from home.

In addition, the ability to review materials remotely allows participants the time necessary to consider the potential benefits, risks and requirements of a given study, as well as, a chance to discuss it with loved ones, caregivers or friends from the comfort of their own homes. Further, some eConsent platforms allow for easy outreach to site teams with questions via chat or video conferencing.

Easing Site Burden with eConsent

  • Expands the geographic range of recruitment efforts
  • Facilitates better discussions between staff and participants
  • Lessens site staff burden
  • Improves tracking, oversight and compliance

In the same way that participants benefit from eConsent alleviating some of the burdens of enrolling in a clinical trial, site staff benefit as well. When eligibility criteria limit patient populations, sites may struggle to find study participants. Using decentralized elements like eConsent can reduce some of that burden by expanding the geographic range of recruitment efforts in a way that is convenient for both participants and site staff.

An eConsent solution can also facilitate enhanced discussions between site staff and potential participants in a trial. By delivering the ICF via a more engaging modality, it can open up avenues of discussion or drive participants to ask questions in a way that a paper consent form might not. Addressing any concerns throughout the consent process and properly setting expectations around the demands of study participation can reduce future patient dropouts. Of course, not every patient will prefer to use an electronic consent form, and some will prefer the high-touch aspect that an onsite visit provides. A robust eConsent solution, however, can manage traditional, in-clinic paper-based workflows, in-clinic electronic workflows, or fully remote consenting options, providing the flexibility to support multiple site processes within a given study and ensuring that site staff are able to meet participant preferences.

As sites struggle to manage turnover and hire qualified professionals, eConsent can also lessen some of the burdens placed upon incumbent employees. Like many of the traditionally paper-based activities in clinical research, the consenting process can be rife with errors and inefficiencies, including the use of outdated ICFs, documents with incorrect dates, or ICFs that are missing signatures. Implementing eConsent technologies can reduce errors and improve ICF version tracking, oversight and adherence as well as compliance, improving the quality of the consent process and alleviating stress for busy site staff.

How eConsent Lowers Costs for Sponsors and CROs

  • Reduces enrollment timelines and FPI
  • Enhances patient engagement and satisfaction
  • Expedites the sharing of ICF revisions and the associated re-consenting process
  • Enables 24/7 access to all consent data
  • Eliminates opportunity for human error and protects PHI
  • Supports optimized digital document version control

For sponsors, eConsent has the potential to enhance enrollment, patient engagement and satisfaction. By allowing research participants the option to review documents and consent remotely, sponsors can reduce enrollment timelines and launch their studies faster. This is aided by applications that provide eICF access to both participants and sites, reducing delays associated with coordinating and scheduling site visits to merely collect signatures. Another important benefit for sponsors is the ability to expedite the sharing of ICF revisions and accelerate the associated re-consenting process. With Good Clinical Practice (GCP) guidelines [4] stating that ICFs should be revised whenever new information that may be relevant to the participant’s consent becomes available, the ability of eConsent to streamline this process can save a great deal of time and cost.

In terms of data collection, storage and management, eConsent can enable round-the-clock access to all consent data. eConsent software tells study teams everything they need to know about consent data while safeguarding protected health information (PHI) and meeting all relevant regulations. It also eliminates many opportunities for human error common with paper consenting and provides clear audit trails. It is important that study teams have the ability to view different versions of the ICFs to ensure that patients are reviewing and consenting to the most up-to-date and correct information. With paper, this can be a tedious, error-prone process. However, eConsent allows monitors and study teams full visibility into their repository of digital consent documents, allowing for more optimized version control.

Finally, according to research by Tufts [5], decentralized clinical trials (DCTs) in Phase 2 studies deliver an increase in value of $8.6 million, on average, per investigational drug, or nearly a five-fold return on investment (ROI). And, in a portfolio of Phase 3 drugs, DCT methods increase value by $41 million per drug, with a 13-fold ROI. Although some sponsors or CROs may be reluctant to make the up-front investment in eConsent or other decentralized trial technologies, the combination of financial, process and engagement benefits of this solution are extremely meaningful to all study stakeholders and positively impact study success.

Applying Medrio eConsent in Clinical Trials

Medrio’s eConsent solution, along with our team of informed consent experts, can offer you a better way to engage with research participants and ensure a compliant consenting process. Unlike many other eConsent vendors, our solution is proven: Medrio eConsent has supported nearly 150 studies, enrolling 18,000+ patients at 1,300+ sites.

For more information on Medrio’s eConsent offering, click here, or reach out today to arrange a demo.


References

  1. Nuttall, A. (2012, March 23). Considerations For Improving Patient Recruitment Into Clinical Trials. RDP Clinical Outsourcing. Retrieved September 16, 2022.
  2. Nuttall, A. (2012, March 23). Considerations For Improving Patient Recruitment Into Clinical Trials. RDP Clinical Outsourcing. Retrieved September 16, 2022.
  3. Harle, C. A., Golembiewski, E. H., Rahmanian, K. P., Krieger, J. L., Hagmajer, D., Mainous, A. G., & Moseley, R. E. (2018). Patient preferences toward an interactive e-consent application for research using electronic health records. Journal of the American Medical Informatics Association : JAMIA, 25(3), 360–368.
  4. ICH. (2016). E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. [Retreived September 16, 2022].
  5. Tufts (Ed.). (2022). DCTs substantially increase financial value based on key performance indicators. Impact Report. [Retrieved September 16, 2022].

Enter a topic, term or keyword below: