E-Consent in a Phase 1 Setting

Posted by: DaVita Clinical Research

Informed consent to participation in a clinical trial involves substantially more than obtaining signatures from subjects on a written form. It includes providing to potential participants enough information about the study so that they can make an informed decision, together with a process that facilitates the subjects’ comprehension of this information and provides the opportunity for any questions. The consent process often continues beyond the time of enrollment, as needed as the study progresses.

Electronic informed consent (eConsent) is an emerging platform for obtaining consent from subjects, either at a clinical site or from home, using a computer-based form instead of traditional paper-based forms. The research community, regulators, and health care industry, are all showing increasing interest in using eConsent to either supplement or replace paper-based informed consent processes.  The novel platform may be used not only to provide the information usually contained in the paper format, but also to evaluate the comprehension of this information by the potential participants. Because it can use interactive interfaces, it can facilitate the ability of the subjects to comprehend and retain the information. In addition, the system allows for rapid notification of any amendments that may affect the participants’ willingness to remain in a study. According to a recent report by CRF Health, two thirds of the top 50 pharmaceutical companies have launched or are planning eConsent initiatives, and the top 10 have already implemented eConsent strategies.

Organizations involved in conducting clinical trials are highly interested in improving the informed consent processes, and find that key business drivers of eConsent interest are increasing the participants’ understanding of consent, enhancing participants’ satisfaction and reducing regulatory risk.

The most important benefits observed with the use of eConsent include a reduction of the time spent by site staff to explain the study to participants, an increased number of participants recruited to clinical studies, a higher compliance of study protocols and procedures, and a reduction in the number of study drop-outs.

In terms of eConsent functionality, there are clear advantages provided by the platform:

  1. Engagement functions: eConsent can be interactive, provide attractive user interfaces, and support multimedia, all of which may dramatically improve the comprehension of content by participants.
  2. Design functions: eConsent can be deployed to sites or homes with digital tablets, and can support the creation of an electronic informed consent by the study team easily, without involving the vendor.
  3. Reporting functions: eConsent can measure which parts of the consent generate questions by participants or are not understood, and it can capture feedback provided by the patients about not participating in a study.

 

While the biggest barriers to the adoption of eConsent are currently its perceived cost as well as regulatory concerns, a recent survey covering 100 biotech, pharmaceutical, CRO and IRB organizations shows that eConsent is being used already, to some degree, by a third of them, and one in four respondents anticipates that eConsent will be used in the majority of their organization’s trials within 3 years2. Although for most organizations it is still too early to tell, almost all of those with enough data report a positive ROI for the adoption of eConsent.

1 Use of Electronic Informed Consent Questions and Answers – Dec 2016 – https://www.fda.gov/downloads/drugs/guidances/ucm436811.pdf

2 CRF Health State of eConsent Report 2017 – http://resources.crfhealth.com/i/783720-state-of-econsent-2017-report/ – CRF Health is the leading provider of patient-centered eSource technology and service solutions for the life sciences industry.