How eConsent Is Changing Clinical Trials

  • July 25, 2018
  • Dan Stempel
  • 2 Minute read

eConsent for clinical trials

With increased convenience and a more streamlined flow of information, eConsent offers benefits for patients and clinical trial investigator sites alike.

Securing patient consent can serve as an obstacle for clinical trial recruitment and retention. With 85% of studies failing to retain enough patients and an average dropout rate of 30% across trials, CROs and sponsors are searching for an efficient way to keep patients informed and engaged.

Electronic Informed Consent (eConsent) has the potential to reduce barriers and help get clinical trials off the ground. By increasing accessibility and enhancing participant understanding, it can improve clinical trial experiences for both patients and investigator sites.

eConsent is gaining in popularity, with 85% of CRF Health survey respondents reporting that eConsent would help them in their roles, and 61% believing that it will allow them to consent more trial participants. Despite the many benefits, however, there are important regulations and challenges for trials to consider when implementing an eConsent strategy.

Benefits of eConsent

Most clinical trials are interested in eConsent in order to increase patient comprehension and satisfaction. According to CRF Health, 90% of survey respondents believe that increasing patients’ understanding of consent is a key business driver. 88% indicated that improving patient satisfaction was another important factor.

eConsent has many clear benefits for patients. It is convenient, allowing them to start the consent process, take a break, and then pick up where they left off. In many cases, patients can begin from home, taking the time to review all information and get feedback from family and friends.

eConsent also allows participants to become better informed. It presents information in a more easily digestible format with links and additional resources. As patients work their way through the electronic materials, they can highlight important details and document questions.

Benefits for patients also translate into positive outcomes for clinical trials. Intuitive eConsent will likely lead to improved compliance as well as higher patient enrollment and retention. The ability to sign consent forms remotely could mean expanding the geographic reach of a study. eConsent allows trials to quickly notify participants with updated information, increasing patient engagement. eConsent is also likely to save trials time and money by standardizing the documentation and approval process, reducing the risk of improperly informed patients, and minimizing the need for on-site consent monitoring.

Challenges of Implementing eConsent

While eConsent is a popular topic among CROs and sponsors, most trials have been slow in implementing it. Some are concerned about the burden of increased costs and comprehensive staff training. According to the CRF Health survey, respondents are most worried about eConsent’s perceived cost and uncertain ROI. Many organizations want to see more evidence of its success before implementing it themselves.

When initiating an eConsent strategy, trials should make sure that their process is compliant with FDA regulations, as outlined in the document, Use of Electronic Informed Consent, Questions and Answers. Keeping these guidelines in mind, studies need to evaluate how eConsent impacts data security, including the ability to protect patients’ private information and align with GDPR standards. CROs and sponsors should also consider how eConsent fits into site workflow, documentation procedures, staff training, and inspection policies.

Despite the challenges, eConsent has the potential to greatly improve patients’ experience with enhanced support, convenience, and comprehension. Informed and engaged patients are more likely to remain in a study, which in turn can help clinical trials boost retention and collect better quality data.

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