Icon, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, and Carnegie Mellon University (CMU) partnered on patient consent process research.
The results, which were recently published in Medical Decision Making journal, show that patient consent forms could be shortened by up to 86% without losing critical understanding or sacrificing the content required by ethics boards. The research also found greater patient engagement when using a shorter paper form or when using a video format, compared with more traditional, paper-based approaches.
Academic researchers at CMU conducted a number of studies evaluating patient-centric and patient-designed informed consent formats. In the first study, 118 asthma patients examined sections of a standard informed consent document for an asthma trial and then selected and ranked the information they deemed critical to their decision making. In the second study, 83 asthma patients were randomly assigned to review either a full informed consent document; a shortened document, based on patient preferences from the first study; or a video that presented patient consent information in an animated format. The video was developed by Icon, using its Firecrest suite of multi-media solutions.
In the first study, patients identified a fraction of the content on a typical informed consent form as relevant to their deciding whether to participate in a trial. Their preferences led to a significantly (86%) shorter consent form, with greater emphasis on aspects that directly affected them (including trial procedures, potential side effects and benefits) and less attention to aspects that mattered less to them (e.g. privacy assurances, procedural information for clinical staff). In the second study, participants who received the shortened paper form and video format absorbed as much information as participants receiving the long form, and described themselves as more engaged. Those receiving the video format rated themselves significantly higher scores on physician trust.
Dr. Lars-Olof Eriksson, EVP Site and Patient Recruitment, said, “Informed consent materials are very often long, complicated and too technical which is why we commissioned CMU to examine how a simpler, more patient-centric approach would affect patients’ understanding, confidence and trust. Through this research, patients have made their information needs and preferences very clear. We have already incorporated the CMU research findings into our Firecrest eConsent and Patient Portal solutions and we remain committed to developing further innovative solutions that drive better patient recruitment and engagement in clinical trials.”
Icon’s Firecrest Patient Portal is the patient’s gateway to clinical trials and has been specifically designed to enhance patients’ understanding of treatment before consenting to participate in a trial. Patients using the Patient Portal can find active trials, complete pre-screening questionnaires and watch educational videos in the comfort of their own homes, before choosing a convenient study location. The Patient Portal also includes a patient visit-by-visit guide, which informs patients about what to expect during site visits.