Adoption of electronic consent (eConsent) in clinical trials has been slow due to various regulatory challenges. However, the benefits of integrating eConsent into the clinical trial process outweigh these challenges significantly. In this article, we delve into the nuances of the current state of eConsent adoption – the challenges faced and the potential benefits it brings to the table for sponsors and participants.
Clinical trials are the bedrock of medical research and breakthroughs. The transition to digital platforms for data collection and consenting processes, like econsent—although slow—has been a significant shift in this field.
Econsent or electronic consent is a system that allows patients and doctors to electronically sign consent forms for medical or surgical procedures. However, electronic consent within clinical trials has faced several hurdles in adoption due to various regulatory challenges that vary from region to region.
Though the US and Canada seem to have more widespread adoption of eConsent in clinical trials compared to Europe, the clear shift towards decentralized clinical trials means that the regulatory landscape is now on the cusp of rapid evolution. The European Medicines Agency (EMA) has propelled this by releasing recommendations that have begun to shape the future of clinical trials by introducing guidelines and regulations for eConsent.
The potential benefits of incorporating eConsent into the clinical trial process are numerous. This article discusses the reasons for the slow adoption, explores potential solutions, and looks at some of the significant benefits that eConsent offers both clinical trial sponsors and participants.
Challenges to Adoption
There are numerous factors responsible for the slow adoption of eConsent in clinical trials.
- Regulatory Challenges – Regulators across the globe have welcomed eConsent, but not without their own set of trepidations. They are chiefly concerned about misunderstandings and varying interpretations of terminologies, regulations, and guidelines, thereby making them cautious in their acceptance of eConsent in clinical trials. Adding to this, the heterogeneity in each country’s configurations and requirements makes the integration and standardization of different systems a challenge. Consenttools.org has identified these as primary hurdles in eConsent adoption that need to be addressed.
- Technical Challenges – Implementing eConsent involves embracing technology and replacing conventional methods. Many stakeholders find it challenging to switch to digitalized data collection platforms and remote consenting processes that come with their own set of hurdles.
- User Experience Challenges – The success of eConsent primarily depends on the user experience. A critical aspect of this is the digital approach’s simplicity, intuitive design, and navigable components. Any discrepancy in these can limit buy-in from both investigators and participants.
It is not an easy task for trial sponsors and trial sites to navigate these challenges. But with a better understanding of these barriers and a holistic approach to counter them, eConsent can be successfully incorporated into clinical trials.
The successful harmonization of digital features, technology, simplicity, and regulatory compliance can propel the acceptance and adoption of eConsent across all stakeholders.
The article will next discuss the numerous benefits that eConsent offers which far outweigh the challenges of adoption.
Benefits of eConsent
Despite the mountain-like challenges, bringing eConsent on board has several benefits for both sponsors and participants in clinical trials. Let’s have a detailed look at them.
For Sponsors
- Streamlined Trial Process – EConsent brings automation to the consent process. It enables a streamlined trial experience with features such as electronic signatures and automated workflows, thereby relieving trial staff from the burden of collecting and organizing information manually. Furthermore, eConsent tools can be easily plugged into interconnected platforms, enhancing the site experience greatly.
- Compliance and Standardization from Day One – EConsent enables immediate documentation of consent in electronic databases, ensuring compliance right from the start. This digital approach also promotes standardization of consent across all trial sites.
- Remote Interactions and Reduced Site Burden – EConsent provides flexibility for remote interactions and decentralized clinical trials. This technology allows remote consenting, eliminating the need for in-person consent while reducing the trial site burden immensely.
For Participants
- Enhanced Patient Education and Communication – Complex medical terminologies and lengthy consent documents often hinder enhanced understanding and pose a patient burden. EConsent overcomes this by employing an interactive multimedia experience. Use of plain language, intuitive design, and formatting pave the way for improved comprehension of the study, disease, and decisions required of participants.
- Greater Access and Diversity – With remote consenting processes, eConsent democratizes trial access. It is now possible for diverse participant groups, regardless of geography, to easily participate in clinical trials.
- Improved Recruitment and Retention – With features allowing for easy navigation and personalized remote interactions, eConsent expedites recruitment while reducing drop-out rates.
Recommendations for Implementation
Encouraging the adoption of eConsent in clinical trials goes beyond merely choosing vendors or contract research organizations (CROs) to assist with configuration tasks. It is critical to embed the informed aspect of consent firmly within the electronic framework.
- Ensuring Personal Interaction – While technological advances enable complete self-administration of eConsent, it is crucial to ensure adequate personal interaction between participants and investigators. Employing researcher-assisted eConsent over self-administered eConsent can provide participants with the comfort of personal contact.
- Using Standard Tools – The use of similar tools by all stakeholders involved in the consenting process will increase acceptance and ensure consistency. Standardizing application of econsent across all trial sites helps in smooth and streamlined site rollouts.
- Integrating with Other Technologies – eConsent harmonized with trial protocols and connected to other technologies, can provide a more intuitive and sophisticated user experience.
- Evidence-Informed Practices – Practices rooted in evidence, such as a balance of plain language and medical terminologies, suitable formatting, and assessment for understanding, can enhance the effectiveness of eConsent.
Econsent Clinical Trials
The future of eConsent adoption in clinical trials is promising despite initial resistance and regulatory challenges. The benefits it offers in terms of streamlining the trial process, enhancing patient education, and improving participant engagement make it a highly valuable tool.
Addressing adoption challenges, employing evidence-informed practices, and pushing for greater awareness and acceptance among stakeholders can make eConsent a cornerstone of clinical trials in the coming years.
As we step into an era dominated by technology, embracing eConsent can truly lead to a revolution in clinical trials, bringing efficiency and accessibility to all.