NHS approves electronic consent technology in clinical trials
Clinical technology and services company Mytrus has announced that its software platform for electronic informed consent has received approval for use by Britain's National Health Service (NHS); the first time e-Consent technology will be used in a trial in England.
California-based Mytrus also had the accolade of producing the first electronic informed consent technology approved for use in a clinical trial by the US FDA, when it was used for this purpose by Pfizer in 2011.
The Mytrus software has since been used by several of the world's other largest pharmaceutical companies in about 30 studies and has received approvals from other national health authorities, as well as 50 institutional review boards and ethics committees.
At a time when bringing a drug to market can cost up to $1 billion, Mytrus believes it can help deliver cost and efficiency savings to academia, pharmaceutical, biotech and device makers.
Mytrus CEO, Anthony Costello, comments: "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 centre of the process. We help patients make better, more informed decisions and our technology has been a major advancement in improving patient comprehension in dozens of studies."
Approval for the use of Mytrus' electronic informed consent in the trial in England was granted by the Health Research Authority (HRA), a division of the NHS. HRA was established to promote and protect the interests of patients participating in research and oversee research ethics committees in England, as well as innovation in research.
HRA is interested in how e-Consent technology impacts both efficiency and the ethical treatment of patients. Research sites worldwide have traditionally used paper documents to share information on study risks, benefits and alternatives, as well as information on what patients can expect in a trial.
Mytrus' Enroll platform uses a tablet computer to deliver a trial overview and key information to potential participants via ‘simple, entertaining videos’. These potential participants read the informed consent document, answer questions to assess understanding and are prompted to review information they don't understand as well.
Research site staff can track patient metrics to better understand where patients need counselling and dedicate time for each potential participant to discuss the study before giving consent.
The newly NHS-approved study, which involves one of the top 10 pharma companies testing a new investigational drug, began enrolling patients in July. The e-Consent pilot is being run in tandem with traditional paper consent so that results can be compared.
An independent study of Enroll by the California Pacific Medical Center Research Institute found that patients provided with paper-only consent were able to correctly answer 58 percent of questions asked on a follow-up questionnaire, whereas those who used an electronic consent application correctly answered 75 percent of the questions.