The clinical trial industry has seen a significant transformation over the years owing to the increased adoption of hybrid and decentralized models. The availability of digital technologies that support these models has made it possible for a larger pool of patients to participate in trials. However, there remains a key area of patient participation that is lagging digitally, says Andrés Escallón, Vice President of eClinical Innovation at Suvoda.
“From patient recruitment to data collection, digital strategies play a big role in the patient journey. However, patient consent is still a paper-based process for many trials. Not only does this slow trial progress, but it risks patient participation,” remarks Escallón.
Recording patient consent is a fundamental pillar of clinical research. After being informed of the relevant aspects of the trial, patients often receive a complex, multi-page consent document, which can be difficult to review and understand.
“Navigating a cumbersome consent process can be stressful. Digitizing this process for at-home review not only gives patients time to consider what they’re consenting to but also fits within an already largely electronic process and experience,” says Escallón.
Considerations for eConsent adoption
Despite the benefits, there are barriers to eConsent use that have slowed down adoption somewhat. According to Escallón, the main hurdle is the lack of uniform regulatory guidance on how it can be adopted, with different countries more willing to accept electronic signatures than others.
“Some countries in the EU, such as Austria, Belgium, Italy, and Portugal, are more willing to adopt eConsent. These countries either have a guidance document that was put out by the regulatory authority, or the ethics committee itself will have eConsent guidance based on what the national signature laws, data privacy laws, and clinical trial regulations will allow.”
With variability in regulations across countries, it is important for companies considering eConsent adoption to select a system with flexibility and configurability at its core. This enables trials to address differences in regulations by allowing different consent methods, consent types, and device needs.
Another critical aspect trial professionals must examine is how consent fits within the overall trial process and patient journey. After consent, patients are screened and randomised within the IRT system. Integrating these steps on a single platform gives real-time visibility into the patient journey throughout the trial.
“Integrating the consent process with screening and randomisation, keeps the trial moving,” explains Escallón. “Before you can use the IRT system, you need to ensure that the patient has consented to the trial. When you have those two systems married, you’re not waiting to know the consent status. This visibility cuts down on delays, better informs supply strategy and maintains trial integrity. It can also align site user processes to make tasks easier.”
Suvoda launched an eConsent solution this year that is built on a single platform with its IRT system, providing a seamless experience for tracking consent, screening, randomising patients, and managing drug supplies all in one place.
To avoid the risk of regulatory non-compliance, Suvoda IRT with eConsent can be configured to automatically flag a patient’s lack of consent. Hard or soft stops can be put in place to prevent those individuals from being accidentally randomised in the trial. And in the event of a protocol amendment mid-study, the re-consent process is quick and simple.
Investing in the technology needed to improve compliance to an ethical principle as important as informed consent should be a priority for the clinical trial community.
The push to fully digitize the entire patient journey is just one element in the web of factors making now the perfect time to adopt electronic consent. With decentralised trials accelerated by the pandemic and expected to keep rising, eConsent is a vital technology for the future of clinical trials.
“The advice I always give is to take the time to understand what the requirements are in the specific jurisdictions that you’re looking to deploy it in,” notes Escallón. “Look out for electronic signature laws and the identity verification process of the patient. A lot of these fall into data privacy. Also, make sure you’re understanding the patient population so that you’re creating it to best help those patients and not just something that’s one-size-fits-all.”
The value of electronic consent management
Electronic methods for seeking, confirming, and documenting a patient’s informed consent in a clinical trial are already actively being used and showing several tangible benefits. As the industry continues moving to decentralised trials, eConsent platforms provide sponsors with the remote patient monitoring capabilities needed to keep trials running following current regulations.
Improving efficiency and eliminating administrative overhead with better document management and version control are some of the additional benefits of using eConsent over a paper-based approach.
eConsent also provides the opportunity to incorporate elements such as branching and skip logic that improves the patient’s experience. The comfort of consenting from home gives them the time to ensure they fully understand the trial they are consenting to.
“What you can also see is how long the patient took to go through the journey,” adds Escallón. “Did they open it, immediately sign and close it? You can increase compliance by following the patient’s consent process and making sure they understand everything. From my experiences working with eConsent systems, compliance has always been outstanding.”
While there are considerations that sponsors and CROs must examine, the many benefits found in an eConsent system outweigh perceived barriers.