Life Sciences

Covid-19 Put the Spotlight on eConsent, and Rightfully So

Informed consent, an integral part of clinical research, ensures that clinical trial participants are well-informed about all the relevant aspects of the clinical trial and that their participation is voluntary.

However, as clinical studies get more complex, informed consents are getting longer and less clear, defeating their intended purpose. According to a survey, 35% of patients who dropped out of a clinical study early mentioned it was difficult to understand the material contained in an informed consent.

Electronic informed consent, or eConsent, as it is commonly referred to, is the digital version of informed consent where paper is replaced with electronic consent. Allowing patients to consent remotely and avoid visiting the trial site can significantly reduce barriers and quickly enroll patients.

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

Get the Guide

Benefits of eConsent include:

  1. Interactive tools such as embedded pictures, audio, and video make the consent process more understandable and easier to read
  2. Electronic signatures, version history tracking, and audit trails increase compliance
  3. Template-driven document authoring for standardization and reusability across multiple studies and regions accelerate turnaround time
  4. Collapsible document sections increased focus and retention
  5. Document archiving and reduced paperwork

With the onset of Covid-19, the adoption of decentralized trials and hybrid trials are on the rise. This has led to an impetus to the use eConsent for clinical trials. Regulatory authorities also saw the benefits of using eConsent during the pandemic. They developed a free eConsent platform to help investigators obtain informed consent remotely when face-to-face interactions are not feasible. It previously only developed guidelines on the use of eConsent.

The increased focus on eConsent and its benefits is tremendous for patients and life sciences companies alike. We will continue to see that it increases patient engagement, leads to better patient retention, and improves clinical trial data quality.

If you are interested in enhancing the site and patient experience, please don’t hesitate to reach out.

 

About the Author

Bhanu Garg is a Sr. Business Consultant on Perficient's Clinical Operations team. With over a decade of life sciences experience, he has worked with global pharmaceutical companies on various projects, including business process automation (BPA), robotic process automation (RPA), content management, and data migration.

More from this Author

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.