Increasing the Use of eConsent Across Europe: The Challenges and Benefits
This blog was authored by Fiona Maini, global compliance and strategy principal, Medidata.
The Value of eConsent
Traditionally, the way to get a patient's informed consent to participate in a clinical trial has been a paper-based process. A participant will sit with an investigator and go through pages and pages of information about the trial and then sign their consent in person. Given the increased number and complexity of trials, there is a real opportunity to make the current consenting process more efficient and less burdensome on all parties.
Electronic informed consent, or eConsent, provides patients with a more interactive and more modern approach to learning about the trial they’re about to be a part of. Using multimedia technology and visualisation, patients are guided through the clinical trial process and what it will entail on their part. With eConsent, patients have the opportunity to flag things that are unclear or raise questions, share the information with family and friends, and electronically sign and give their consent—they can do all this remotely and in the comfort of their own home or, if they prefer, at the site with the investigator. Quality risks are also reduced, as these documents are digitally hosted in secure validated systems, audit trails can show the movement of the trial participant through the informed consent and holds an electronic record of when the consent form was signed, and documents are less likely to be lost or misplaced.
This is beneficial for many reasons—patients can be better educated and informed about the clinical trials, investigators are able to consent patients remotely, and it reduces patient burden and risk.
The Barriers to Adoption
Despite these clear benefits, most countries in Europe still don’t accept eConsent for various reasons. Many European countries’ national laws don’t allow for electronic signatures because of the perceived risk of mis- or false identification of patients. However, now there are many secure methods to confirm someone’s identification remotely.
In recent years, we have seen the UK and Belgium authorities come out with formal statements guiding on their expectations on the use of eConsent. The FDA in the US have accepted and encouraged the use of eConsent for many years. These guidances are very comprehensive and exactly what the industry requires. We encourage more authorities to put forward their positions to help give clear guidance on this topic considering local and national laws.
In order to address some of these industry challenges, Medidata is co-chairing the eConsent Task Force, which is a collaboration between European CRO Federation (EUCROF) and eClinical Forum (eCF) members. The objective of the task force is to understand the reasons behind slow adoption of eConsent in Europe, provide comprehensive guidance to the industry and help provide insight to authorities on these new processes and technologies.
By outlining the benefits and practical considerations for implementing, including the nuisances in different countries, the task force hopes to elevate the conversation and invoke change. By educating the industry on these available technologies and demonstrating its value where already accepted and used, sponsors and researchers can make better decisions and Europe can continue to drive innovation.
The task force recently published a paper titled ‘Electronic Informed Consent Implementation Guide: Practical Considerations’ to support these efforts. The paper includes:
- An overview of eConsent, including the interactive education component, eSignature and remote and on-site options
- How eConsent can improve patient experience and advance the consent process for sponsors and sites
- How COVID-19 has accelerated the use of eConsent and demonstrated its value
- Detailed guidance and a roadmap for the implementation of eConsent
- Stakeholder perspectives, regulatory acceptance and country-by-country positions on eConsent
The paper has been reviewed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and has been put forward for review by regulatory bodies across Europe, including the European Medicines Agency (EMA).
Future of eConsent
COVID-19 has accelerated the use of technology across the clinical trial process. Over the past year, clinical trials have had to become more modernised because of the strange environment we were operating in. The end-to-end process has been going digital for several years, but the pandemic has certainly expedited the progress, including the use of eConsent.
These technologies and tools are gaining more traction and interest from authorities around the world, and we will start to see more acceptance and adoption in the coming years. The core focus of the industry and of any clinical trial will always be the patient. So if we can lessen the burden or ease the process for the patient in any way, as well as accelerate the time to market to get drugs and treatments to patients faster, then that’s something we need to do.