Thinking about electronic informed consent? In this short video, industry expert Sandra "Sam" Sather discusses the three key benefits of adopting eConsent in your clinical trial.
Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 30 years of clinical experience, has a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. SAM has been dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years as a CCRA and CCRC. She is a current member of the ACRP Academy Board of Trustees, and ACRP Regulatory Affairs Committee (RAC); SAM has been a clinical research coordinator, site manager, sponsor and CRO monitor, auditor, trainer and quality manager. She has multiple training, monitoring and project management experiences of diverse size, and objectives with a variety of global clients. She is a frequent speaker at industry conferences and has authored dozens of courses for clinical research training programs. In 2002 she co-founded Clinical Pathways (CP), LLC.
There’s some exciting things happening in clinical research. And one is patient-centric focused trials. So in the past we’ve really focused on the purpose of the study, to get the product to market. And now we—we’ve learned that— to really focus on the patient.
1. Enhanced Understanding and Comprehension
eConsent can improve comprehension with the design of the presentation to support the adult learner.
So you can have multi-media, so you can be presenting information in different formats. So you can mix video with pictures and text. You also can have the patient pause, go back over information, they can listen to a video as many times as they would like to.
In electronic consent we have the ability to build in where they can pause and actually type in questions, or indicate they have questions on certain sections.
We have many, many opportunities to support different kinds and levels of learning and understanding for patients in the consenting process.
2. Reduced Patient Burden with Remote Consent
Currently with the informed consent process, a patient comes into a research center, and they might be travelling from far away. So they might ah, be not feeling good, they might have a pretty significant illness. So to be able to travel, park, be able to get into the re—the research institution can be quite challenging.
So saving them the trip when they could be at home, it also makes it much more timely.
Another reason it’s much more supportive is that when they’re at home, they would have access to their consent remotely, to be able to look back at certain sections.
Why go all the way to a research center when you can consider a study and remotely consent.
3. Customized Consent for Diverse Participants
The challenges with the way that informed consent has been done are many. Some include the length of the consent. The length that the consent can range from fifteen to thirty pages. And the information is quite complex, very technical, ah, very hard to get into the reading level for the participants.
A good informed consent would be one that includes the language of the consent is at the reading level and understanding and language of the participant.
For example, when we have a participant that is unable to read and write, they could listen to the audio version of the informed consent and see video and also see—see pictures that are integrated in together in the presentation.
Meeting the individual needs of a particular type of patient coming in, or subject coming in, it’s hard to do that on paper, because if I present a paper consent, it’s gonna be the same for each patient. How I go through an electronic consent, can be different from patient to patient, and we can map that.
So if we get this right, if we really support the patient, it can make the difference between a subject doing well on a study and—and/or coming onto a study not knowing, not wanting to be. So it helps in our retention, it helps in the quality of our data. Better patients, better data.