Many Medical Affairs professionals agree that the Informed Consent process is among the weakest part of any clinical trial: consents are too long, wording is difficult to understand, and its terminology frequently uses words not familiar to lay people. The COVID-19 pandemic stimulated the adoption of several digital tools (hence avoiding patients’ visits to the hospital) to include the e-consent, a great improvement in the recruitment and retention of patients in clinical trials.
According to Tufts researchers, clinical trials in a variety of therapeutic areas experience patient dropout rates close to 20 %. Although every patient dropout cannot be attributed to failures of the consent process, Advarra’s 2021 research titled “Retention in Clinical Trials” highlights a key link between consent and dropouts. According to Advarra, “35% of patients who dropped out of a study early reported that it was difficult to understand the Informed Consent Form compared to just 16% who completed their trial.” Advarra concludes that patients were more likely to continue the study if their expectations were appropriately set during the informed consent process.
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