CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Mika Lindroos, director of product management at CRF Health, which provides electronic Clinical Outcome Assessment (eCOA) solutions for global clinical trials.
Q: The FDA recently released a draft guidance with recommendations for using electronic informed consent (eConsent) to help improve human subject protection and reduce regulatory burden in clinical trials. How can eConsent achieve these goals?
A: Informed consent involves more than just obtaining a participant’s signature. It’s about the learning process and patients truly understanding what they are signing. Instead of giving potential participants lengthy paper-based consents, an electronic solution can offer tiered information delivery. Interactive content can allow patients to learn about specific terms or topics and add depth to the learning experience. Multi-media features make the content easier to understand. Some people, for example, like to skim the text and seem to learn more by watching a video. With eConsent, there can also be interactive assessments that test the patient’s understanding of the topics. All of this contributes to better learning and comprehension of the content.
With better learning, patients can make a more educated decision about whether or not to join the study. Sometimes patients have false expectations. When this happens, they are disappointed when the study starts and they realize what the trial is actually about. Some patients consent to participate in a clinical trial without fully understanding what procedures or commitment will be expected of them. When patients understand the study and its requirements, it’s more likely that they will be committed to finishing the trial and complying with study requirements.
From the site perspective, the regulatory burden associated with the informed consent process often comes from mistakes that happen with consent documentation, using the wrong version of the consent and not adequately capturing the whole process so that it can be properly reconstructed afterward. Electronic informed consent can make the process easier for sites and capture everything that happens during the consent process. It can ensure the site is using the right version of the consent, capture which questions a patient had during the consent process and indicate whether the study staff addressed those questions. Electronic informed consent can digitally track and time-stamp interactions between study staff and patients, which supports better documentation for each consented participant.
Q: While technology solutions help streamline processes and reduce costs, principal investigators are inundated with a growing number of technologies that rarely interact with each other. How can this burden for sites be addressed?
A: That is an issue. For all the tools we develop, whether it’s a patient-facing interface or site-facing interface, we put a lot of effort into designing the usability, thinking about user-flows and trying to make them as easy-to-use and as intuitive as possible. That doesn’t resolve the problem of several systems, but at least makes it less painful to use a single system.
In addition, our platform provides integrated capabilities. We can typically integrate our platform with data warehouses and IVRS systems. In addition, our new electronic informed consent solution, TrialConsent, can be fully integrated with our TrialMax eCOA platform or delivered as a stand-alone solution. The same operational tools and devices can be used for both eConsent and eCOA at the site and removes the need for any additional consenting technologies to be included in a trial’s design.
Going forward, better industry standards will make it easier for technologies to have the capability of transferring data between different systems. That is the natural direction and I am sure we will see more of that.
Q: Many companies are looking to integrate new technologies into clinical trials that make it easier for patients to participate as the industry adopts a more patient-centric drug development model. How do you see these solutions evolving going forward?
A: The FDA draft guidance on eConsent talked about the possibility of remote consent, which would allow patients to complete the informed consent process, or re-consent, at home whenever it is convenient for them and they have the ability to discuss it with their family. They can also access it for reference, at a later time, should they want to. I definitely see that as a trend.
Similarly, on the eCOA side, I see wider adoption of the Bring Your Own Device (BYOD) model going forward, which allows the possibility of patients using their own devices for electronic patient reported outcomes (ePRO) anywhere, anytime. The industry will get there. But by its nature, and because we need to be careful about how the BYOD model might impact the way that the patient actually interacts with the clinical trial, the industry must be careful when taking those steps. But I definitely see that is the direction that we, as an industry, will be going.
This article was reprinted from Volume 20, Issue 37, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »