The evolution of patient engagement and eConsent in the COVID-19 era
The pandemic has fast-tracked the adoption of decentralized trials, which means new approaches and technology are essential to help patients stay engaged.
Like every aspect of the drug development process, clinical trials are rife with proverbial potholes that can slowly chip away at progress and delay timelines. Thousands of dollars go into recruitment, engagement and retention efforts, yet inevitably subjects still drop out. There are many reasons why this happens and when, which is why clinical trial professionals are continually seeking ways to alleviate this ongoing burden.
The COVID-19 pandemic exacerbated some of the challenges associated with clinical trials, but it also fast-tracked the adoption of decentralized trials as well as some technologies that helped subjects participate remotely.
Making patient consent more patient-centric
Consider the consent process. Traditionally, trial participants are presented with a paper-based informed consent form (ICF) that’s long and complicated to read. Site personnel often spend a considerable amount of time reviewing a study with participants. They also must repeat the process repeatedly for patients who participate in multiple clinical trials.
For example, consider how a trial focused on slowing the progression of Alzheimer’s disease might work. The trial might seek subjects who are starting to show symptoms but have not yet been officially diagnosed with the disease. Typically, these are elderly people with some cognitive deficits. To obtain consent, patients could be presented a text-dense PDF that reviews everything from the number of visits to how many months they will have to be in the trial to their comfort level with PET scans. A physician or research associate would likely walk through details with the patient, and in some cases, the patient’s caregiver.
Now, imagine an approach where a patient is presented with an iPad that explains the details of the trial in layman’s terms with video, graphics and text. At any point, the patient might pause the presentation and ask a question that could be answered by the program or could be forwarded to a staff member. The program could be customized for that patient so it shows what an individual’s schedule would look like over the coming months and, based on zip code, how many miles their home is from each site. While this is not the description of an actual system, it’s one that isn’t hard to envision considering the capabilities of today’s technology. It flips a process that today is rather site-centric to one that is patient-centric.
The screening and consenting phase is a critical time because it’s the beginning of the journey with a patient. It’s critical to securing informed consent which formally includes the patient in the study. The journey is critical to ensuring the patient follows the study protocol, that the patient stays in the trial and that the patient might consider a future trial. Studies rely on patients, and the experience that patients have matter. To be patient-centric, you need to know going into this journey what that patient really cares about. You need to understand their preferences, value the time they give and make it as seamless as possible for them to participate. Technology that’s focused on providing an elevated patient experience can help improve enrollment and reduce the chances that patients will drop out of studies.
How eConsent minimizes burdens
With COVID-19, eConsent functionality went from being an optional add-on to a feature that contract research organizations (CROs) and sponsors considered essential. Preferably, the feature is fully integrated with a clinical data management system or electronic data capture system because the last thing people want to do as they’re adapting a trial for pandemic conditions is learn a new program. Also, with COVID trials, there was a greater need for re-consent because trial protocols were changing rapidly. So, systems that didn’t require additional complicated training and integration, or a wet signature, became the norm out of necessity.
Adding eConsent to a CRO or sponsor’s existing clinical trial infrastructure could be a paradigm shift, depending on how a company is organized. For instance, data managers may not be accustomed to setting up any type of eConsent collection and tracking. So having a module that can be added to an existing platform, like the eConsent module in IBM Clinical Development, can minimize the work associated with learning and rolling out a new application.
Once the data manager or a colleague in clinical operations, study start-up or regulatory has an approved consent form, they can use the module to deploy the form digitally via eConsent by copying and pasting the approved content into the tool. A special area can then be added for signature block content for the study participant, a legally authorized representative and the site personnel. The process works like this:
- The CRO receives the approved content from the site institutional review board, the site itself or the sponsor.
- The CRO digitizes the content and assigns it to the appropriate site.
- Participants consent electronically using the content provided. Study participants receive a hyperlink to access the system and begin their onboarding, which includes adding any electronic signatures to their consent packets.
If a protocol changes and the ICF content needs to be amended, the CRO can push through a packet amendment using the same, simple process. The system tracks the update as an amendment, and once it’s approved and activated, it replaces the prior version at all assigned trial sites. Site personnel then obtain re-consent for any applicable subjects by sending them the new packet. This process helps coordinators and researchers focus by getting them involved only if patients have questions rather than requiring them to repeat the same consent tasks repeatedly.
Increase efficiencies and reduce redundancies
Last year forced us to reevaluate how and where we teach, learn, and work. We’ve become more accepting about performing tasks remotely, and often we just expect the technology to exist that will empower these lifestyle changes. For clinical trials, this transformation has been significant. Yet, there’s still room for improvement. At IBM Watson Health, we’re trying to understand the unmet needs of everyone involved in clinical trials. That’s why we’re continuously innovating our platform. If all stakeholders are using the same platform for consent, patient- or caregiver-reported outcomes and data capture, we can help significantly increase efficiencies, reduce redundancies, and accelerate timelines.
Our goal is to reduce burdens on trial participants as well, so they don’t have to visit the site in person as often. By digitizing consent information, we’re not going to eliminate patient dropout, but we can improve the chances that people will be more willing to participate by making it easier.