Patient Centricity By Design: Informed Consent Engagement

The informed consent process is a critical introduction to clinical trials but often burdens patients with lengthy, complex documents. According to a study by The Center for Information and Study on Clinical Research Participation (CISCRP), up to 35% of patients who decline to participate in a clinical study attribute their decision to their inability to fully understand the informed consent document.

To better support participants, sponsors are advised to invest in simplified, patient-centered consent forms. During this investment, it is also crucial that teams engage with patients or focus groups for feedback, but this can also be challenging when trying to incorporate their perspectives.

Recently, a Top 25 pharmaceutical client collaborated with expert advocates from the Medidata Patient Insights Board (PIB) to compare a simplified consent form with the standard one, working with patient advocates to outline more captivating methods for utilizing an enhanced, standardized ICF to improve the participants' consent process. Delve into their combined findings by accessing the case study below.