The movement to shift informed consent in clinical trials from paper forms to electronic devices has notched up another victory. Mytrus and an unnamed top-10 pharma company made the advance by becoming the first organizations to win clearance to use e-consent in a trial in the United Kingdom.
Officials at the U.K. Health Research Authority (HRA) have signed off on the use of the technology, giving Mytrus' e-consent system the distinction of being the first to be used on both sides of the Atlantic. The U.K. trial, which Outsourcing-Pharma.com reports is looking at an autoimmune drug, got underway in July and is using Mytrus' e-consent technology alongside traditional paper forms. By running both systems in parallel, the organizers of the study hope to gather data showing how the new technology compares with paper.
Mytrus is confident its technology will compare favorably to the old way of working. "The use of electronic media to explain a study and collect participants' acknowledgements and signatures is not only a more efficient way of collecting informed consent but also puts the trial volunteer or patient at the center of the process," Mytrus CEO Anthony Costello said in a statement. Multiple leading drugmakers are looking at e-consent--Mytrus claims to have worked with 8 of the 10 largest pharma companies--as a way to improve their own operations and the patient education process.
Adult education studies have consistently shown there are better ways to digest information than long paper forms, the traditional format used for informed consent in clinical trials. This is one factor that has encouraged the likes of Pfizer ($PFE) and Shire ($SHPG) to trial e-consent technologies, but there is a belief that the economics will make sense, too. Mytrus touts its Enroll tool as a way to improve the performance of clinical trial sites, notably by shortening study start up timelines and cutting the incidence of regulatory failings.
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- and Outsourcing-Pharma.com's article