Transforming Clinical Trials with Electronic Informed Consent.

Transforming Clinical Trials with Electronic Informed Consent.

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A female provider talks with an older male patient and shows him something on the ipad.

By Petros Okubagzi, MD and Mary Anne Hinkson


Improving access to clinical trials starts with streamlining the informed consent process and making it instantly available — anywhere, anytime.  Data from MedStar Health Research Institute is paving the way through our proven, secure electronic consent solution.


Clinical trials allow participants to have new treatments that could positively impact their health and help create the future of care for other patients.  But for all the good that clinical trials can bring, the traditional paper-based informed consent process can slow progress and narrow the pool of people who can participate.


MedStar Health Research Institute, envisioning the future, expanded access to clinical trials by moving to an electronic informed consent solution using Decentralized Clinical Trials recommendations created by the Clinical Trials Transformative Initiative (CTTI).  The electronic informed consent solution allows patients to digest information about the trial at any time, from anywhere before signing up.


Clinical trial participants must learn the details about a study before deciding whether to be involved.   The informed consent process, regardless of the format, paper-based or electronic, must adhere to the requirements outlined in the regulations.  During the consent process, the patient meets with the research team to:


  • Learn about the trial criteria
  • Get answers to their questions 
  • Discuss their participation with loved ones
  • Sign an informed consent 

E-consent offers a feasible and robust alternative to face-to-face consenting approaches.


MedStar Health Research Institute has been active with CTTI for nearly 15 years.  We were an early member, and the president of our research institute and Chief Scientific Officer, Neil J. Weissman, MD, FACC, FASE, is a founding member of the CTTI Steering Committee.


Through our research and in collaboration with CTTI and other working groups, we now offer an end-to-end electronic consent solution (offering a paper-based option based on participant preference) to help open clinical studies to a geographically larger and more diverse patient population.


Transforming clinical trials with CTTI.

The Clinical Trials Transformation Initiative is a public-private partnership founded by Duke University and the U.S. Food and Drug Administration in 2007.  CTTI now includes more than 500 organizations that freely discuss issues and create solutions to make clinical trials more efficient and effective.


MedStar Health Research Institute joined CTTI to help transform clinical trials. As an early adopter, MHRI is always looking for ways to improve trials and make them more accessible to our community.  As a member of CTTI, we contribute to helping understand the barriers that keep many people who qualify for trials from enrolling, such as:


  • Cultural hesitations about medicine at large
  • Misperceptions about the clinical trial process
  • Institutional and regulatory hurdles that make enrollment difficult

Solutions like eConsent provide an efficient and streamlined way to obtain consent from study participants and can help enhance engagement and more profound the pool of potential participants.

Innovation amidst the pandemic.

While adoption of CTTI’s recommendations has been slow nationally, the COVID-19 pandemic accelerated digital transformation at research institutions as healthcare facilities began to practice telehealth.  MedStar Health Research Institute launched our eConsent program in 2020, which facilitated research continuity when face-to-face approaches were not possible.


Continuous feedback meets unexpected challenges.

A pilot study was conducted to ensure the reliability and validity of the eConsent solution.

We were pleased to receive positive feedback from research participants as we rolled out the eConsent solution.  Research participants use digital devices they are already familiar with and have the ability to consistently review study materials and discuss questions with site staff without having to visit the research site.  This eConsent solution also enables research participants to read the consent at their own pace and discuss with family members if participation is right for them.


Transforming trials and opening doors to the future.

A benefit to adopting eConsent includes multimedia elements such as video or links to help test for research participant comprehension of the material and provides a glossary for terms and definitions. Implementing eConsent gives patients with travel, socioeconomic, or mobility challenges an opportunity to be involved in cutting-edge science without traveling to MedStar Health.


An eConsent solution allows us to open some trial opportunities to a more extensive geographic area.  While participation still requires a mobile phone or internet access, eConsent helps address inequity by making clinical trials more widely available.


The electronic consent form can also be freely shared and forwarded, allowing loved ones to be better informed about the trial requirements.  Family members often support trial participants, and their full understanding can improve the participant’s experience and the rate of completion.


As we look to the future, we anticipate more U.S. clinical trials will be decentralized, with patients dispersed in many locations.  Centers such as MedStar Health Research Institute consider the eConsent solution a standard for clinical trials instead of novel functionality.


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