eConsent and Clinical Trials

Clinical research activities become possible when patient volunteers give their consent to participate in a trial. Informed consent, which was introduced as part of the “Nuremberg Code” in 1947, is the beginning of the relationship between a researcher and study participants. This important step gives participants all of the information that they need to know about their role in the clinical trial. Informed consent is a key part of enrolling patients in a clinical trial and a central part of ICH GCP, as consent must always be given freely. 

What is eConsent?

In the past, consent was received through a traditional pen and paper approach. More recently, there has been a growing shift towards electronic consent, also called eConsent. 

It is not merely procuring a digital signature, it encompasses all aspects of the traditional consent procedure. It incorporates multimedia elements, allowing patient volunteers to have an interactive and engaged informed consent experience.

The traditional approach to gaining consent isn’t ideal for everyone and is rather uncompromising. The degrees of health literacy vary from patient to patient, making it extremely difficult to standardize the traditional consent process. By using alternative media, including video, audio, and infographics, patients gain a better understanding of what their participation in the clinical trial entails.

More and more industries are turning to digitalization, and the pharma industry isn’t an exception. Digitalization is an inevitable part of the future, and it is important to consider its advantages and disadvantages. In this document, we have compiled some of the pros and cons.

Key Benefits of eConsent

So, what benefits are realized by the study participants when they use the eConsent method?

Wrote the benefits in points, so that it can be easy for users to read and understand.

• Patient-friendly approaches: Firstly, it offers a more patient-friendly approach and diversifies the ways in which information can be presented to the patients. This increases the likelihood that patients will comprehend the information that is being presented to them. eConsent gives patients that normally would have trouble understanding convoluted medical information, the ability to view the same information in a more intelligible format.
• Digitalized approach: digitalized approach allows study subjects to choose their preferred way of learning, tailoring the consent process to their comprehension ability.
• No burden of tracking paper copies: When eConsent is used in a conventional trial model during an onsite visit, it reduces the site’s burden by eliminating the need to track paper copies. It is especially efficient in studies where re-consenting is expected – protocol amendments, emerging safety data, etc.
• Enhances patient recruitment and retention: Thus, eConsent makes life easier for clinical research sites and investigators. It helps researchers test and reinforce participants’ understanding and, improves the patient recruitment process while bolstering patient retention.
• Communication with research participants is easier:  With eConsent, sites can reduce the time for administrative work, while mitigating quality risks at the same time. This allows site staff to focus on high-priority activities and makes it easier for them to communicate with study participants.

Some Drawbacks of eConsent

However, there are also certain challenges associated with creating an efficient tech infrastructure for the implementation of eConsent as it should reliably provide the following:

• Data integrity;
• Transparency regarding the terms and conditions;
• Protection of confidentiality of the participant’s data;
• The participants’ access to internet-based services.  

Furthermore, eConsent requires new software implementation and making changes to standard operating procedures. This means that many sites will need additional funding to implement the required technology.

Conclusion

While eConsent technology has been around for some time, the clinical trials sector has been slow to adopt it, preferring to adhere to traditional models. The COVID-19 has brought eConsent back into the spotlight as CROs and sponsors were forced to rapidly adapt their clinical research models to the restrictions brought about by the pandemic. As the industry pivoted to decentralized trials and remote monitoring, utilization of eConsent has drastically increased . Digitalization and eConsent will undoubtedly become firmly established as standard practices in the years to come. 

About Cromos Pharma

Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management.

Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Türkiye to offer exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials.

We provide accelerated study start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data.

Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is located in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.

If you have any questions or want to find out more about how Cromos Pharma can support your next clinical program please get in touch with us by emailing inquiry@cromospharma.com.