By: Camila Matheny, Andrew Mackinnon, and Kevin J. Aniskovich
An often quoted analogy for recruitment into clinical trials is that of the ‘leaky pipe’. In this analogy potential participants drop out of the recruitment funnel at every stage in the process from identification, pre-screening, consenting, screening, randomisation and trial completion.
Research in 2020 [1] showed that of 100 participants identified for pre-screening, only 8 will be randomized, and only 7 will complete the trial. Given that a recent review with the Medable Patient Champion Network (PCN) highlighted that the paper consent process was often considered as ‘intimidating’, the fact that up to 80% [2] of potential participants are lost during the consent process is not surprising. Metrics such as these highlight the importance of being able to provide a potential participant with the details of a clinical trial in a manner that both engages and educates them. This helps ensure that their very first experience with the trial, and at times the research facility, sets the tone for a positive trial experience.
Once enrolled into a clinical trial, the process of educating a participant and ensuring the consent form is understood, has a direct impact on their retention. Research from CISCRP [3] showed that 35% of participants that dropped out early from a clinical trial found the consent form difficult to understand, compared to only 16% of participants that completed their clinical trial.
With the broader adoption of digital informed consent, also known as eConsent, it is important to highlight some of the key benefits that this approach can bring to participant education. Let’s deep dive into the benefits digital Informed Consent with enhanced media can offer to the participant education: The ability to engage with participants more effectively will increase comprehension and overall satisfaction with the trial experience.
Research is showing that participants are happy to adopt eConsent as the route into a clinical trial. Results from a 2020 study[1] across 940 participants who used eConsent as part of two protocols at Memorial Sloan Kettering showed:
83% of participants stated that eConsent was “Very Easy” or “Easy” to use 95% of participants would recommend the use of eConsent to other participants In both protocols, participants demonstrated higher levels of comprehension as measured through surrogate marker scores. As the evidence shows, enhanced multimedia has been proven to provide a better and more effective way for participants to learn about their responsibilities in the clinical trial. However, creating study specific videos each and every time a protocol is written is a time consuming task that can often present challenges to the study set up timeline. As a result of that, many sponsors are seeking guidance on how to create an effective multimedia library that is quick and easy to deploy, and also drives a better participant experience. The major interest is to understand what types of resources to include, such as videos and knowledge-check questions, and to determine the most efficient strategies to incorporate these elements into their diverse portfolio of clinical trials studies.
Now that we have a more clear understanding on the benefits of eConsent, are there specific benefits of using multimedia or video in participant education?
“Deficiencies in health literacy and reading comprehension, together with issues of health equity and access, have caused widespread delays in enrollment and downstream drop out rates to be a source of pain for clinical research,” shared Kevin Aniskovich, President and CEO of the medical communications company, Jumo Health. Aniskovich continued, “one way to combat this issue is to ensure complex medical and legal documents can be transformed and presented in ways that patients can understand and most importantly, act upon. Use of storytelling methods, using animation for example, has emerged as the leading form of medical education medium at Jumo Health as we develop educational libraries for our pharmaceutical customers.”
When considering the use of animation as a medium in your library, it’s important to understand how the human brain processes information. Studies show that between 40% to 80% of what a person hears is immediately forgotten, and that 50% is recalled incorrectly. After three days, merely 15% is recalled correctly making verbal communication ineffective at best.
“Interestingly,’ stated Aniskovich, ‘the human brain processes images 60,000 times faster than text alone and research has proven that by using visuals as the basis in communications leads to an impressive 65% of information being retained after three days.”
Sponsors should look to evaluate their current informed consent process through a multimedia and patient education lens, concentrating in content that can be used across different studies as an economical solution to their upfront investment.
For example, creating a video library is an excellent way to answer basic questions related to topics typically not well known by first time trial participants such as what is an informed consent, trial responsibilities, requirements versus options, randomization and more. These videos can be created in many different languages and are a great way to add a flexible way for participants to learn about key concepts of a trial in a more engaging manner than offered by the traditional paper consent method.
Knowledge questions are another recommended another area of focus. Having a library of localized knowledge questions focused on common informed consent topics can allow sponsors reusability across trials and reduce the burden on individual study teams. These knowledge checks should be designed to facilitate a candid conversation between Dr and participant about the important topics prior to informed consent signature. The most recommended topics are around trial responsibilities, insurance coverage, data privacy, withdrawal or optional consent data storage.
Creative displays of the protocol schedule, or an interactive patient journey map, can also help participants to understand their requirements and responsibilities when on the trial as opposed to the traditional schedule of assessment tables that can be confusing, or even intimidating for a first time trial participant. Having these type of graphical images standardised in format, colour and structure can further assist a study team in quickly reaching a final eConsent template.
A hyperlinked glossary of terms is another great feature to add to a multimedia library. Participants often find themselves overwhelmed by the sheer volume of information they need to comprehend, and even when written at the recommended grade 8 reading level, medical jargon will only further complicate the process. Providing a localized glossary with embedded hyperlinks, can help participants more effectively grasp the key terms and concepts associated with the trial, as well as offering a deeper review where a participant wishes to learn more. This offers a more comforting and comprehensible experience to the participants with the important concept of optionality introduced.
In summary, an enhanced multimedia library can be created with content focused both on improving the comprehension process for participants, and reducing the burden for sites. GCP requirements mandate that sites are entrusted with the duty to ensure participants are thoroughly informed throughout their enrollment in a clinical trial study. Utilizing a multimedia library for this purpose has been demonstrated as an impressively effective solution to fulfill this responsibility and can ensure that a participant’s first engagement with a clinical trial is filled with empathy and education rather than confusion and intimidation.
Camila Matheny, Executive Director, DCT Offerings An expert in clinical trial operations, Camila works closely with pharma, biotech, and CRO customers to articulate the value of adopting and implementing digital technologies to deliver decentralized and hybrid clinical trials. As a member of the SCDM eSource Consortium, DTRA, and EFGCP, Camila leads with data, the driving force behind bringing new therapies to market. With over 15 years of clinical trials experience, a background in data management, and a passion for the latest cutting-edge technologies, Camila provides a unique combination of expertise to help guide customers towards a better way to adopt and implement technologies the most impactful and sustainable way.
Andrew Mackinnon VP, GM, eConsent As General Manager for eConsent, Andrew Mackinnon oversees the development of the eConsent product, as well as the implementation of eConsent in Medable studies, ensuring that Medable’s clients can run high quality, effective and efficient decentralized clinical trials. Andrew has 20 years of experience in managing clinical trials at large Pharma, Biotech and CRO companies, most recently as a Senior Director in one of Covance’s therapeutic area delivery groups and as Head of Business Performance. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients and looks to leverage his broad operational expertise to improve how this approach is utilized.
Kevin Aniskovich, President & CEO, Jumo Health Kevin is the President and Chief Executive Officer of Jumo Health. In this capacity, Kevin is responsible for the strategic direction of the organization, playing primary roles in product development and global market positioning.
A serial entrepreneur, Kevin’s career in health care started when his mother was diagnosed with a rare disease and faced a dearth of understandable information about her diagnosis and care. Having most recently served on the market research side as President of Great Blue Research, Kevin was previously the Chief Innovation Officer of Sharecare, responsible for product strategy and operations of its service offerings directed to healthcare professionals and institutions.
Prior to joining Sharecare, Kevin was the Chief Innovation Officer of Remedy Health Media, responsible for strategic planning and product development for its digital assets. Kevin joined Remedy as part of its acquisition of Intelecare Compliance Solutions, a company Kevin founded and led as its Chief Executive Officer. At Intelecare, Kevin developed a proprietary multi-channel communication platform that provided compliance reminders along integrated mail order pharmacy services – a first of its kind.
Prior to founding Intelecare, Kevin held senior level sales and marketing positions for Epocrates, the market leader in clinical information and decision support tools for health care professionals, and co-founded HealthInfo Corp., a producer of patient education and continuing medical education videos. Kevin’s 25+ years of experience in health care has covered marketing, technology and sales.
Among other recognitions, Kevin was named one of PharmaVoice Magazine’s Top 100 Most Inspiring People in Life Sciences and has led Jumo Health to be recognized on the Inc. 5000 list as one of the fastest growing private companies for the last two consecutive years.
