One key area in clinical trials that could benefit from connected health digital solutions is capturing informed consent. Traditionally, patients have signed informed consent forms that are very text-heavy, yet they don’t really understand the rights, responsibilities, risks, and benefits of the study. Explaining the complex details of a trial can add a significant amount of time to the recruitment process and result in patients withdrawing their consent or from the trial altogether. This can be a very costly situation for the sponsor.
To address these informed consent challenges, several technology companies have created solutions to improve the process. In fact, this area has seen so much activity that the FDA and other regulatory agencies have provided guidance on using electronic records and electronic signatures to obtain informed consent. Let’s take a closer look at some of the solutions on the market today.
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The first one is eConsent, a web solution that allows sponsors to share the text document of the informed consent form electronically, and to capture e-signatures from patients. In addition, sponsors can add supplemental information that explains patient rights, responsibilities, and risks in simple formats. Patients also have the ability to access their informed consent throughout the duration of the trial for reference purposes, and even bookmark areas that they would like to discuss with the physician or site staff.
The second example is Mytrus, which is similar in nature to eConsent. However, rather than being just a document repository and signature capture solution, Mytrus uses additional training techniques to ensure that the patient understands to what they are consenting. The biggest differentiator is that their method of instruction consists of interactive learning methods. It provides training and then measures the patient’s understanding of the content.
Applications like these help teach subjects about the trials they are considering, as well as confirm that they are in agreement with the terms. Therefore, incorporating these solutions into clinical trials improves adherence, compliance, and commitment.