Mytrus, a technology and services company working in clinical trials, has announced its software platform for electronic informed consent has received approval for use by Britain’s National Health Service (NHS). It is the first time e-Consent technology will be used in a trial in England.
Mytrus also was the first electronic informed consent technology approved for use in a clinical trial by the FDA in 2011. It has since been used by some of the world's largest pharmaceutical companies in about 30 studies and received approvals from other national health authorities, as well as 50 Institutional Review Boards and ethics committees.
“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," said Anthony Costello, CEO of Mytrus. “We help patients make better, more informed decisions and our technology has been a major advancement in improving patient comprehension in dozens of studies.”
inVentiv Health is an investor in Mytrus and integrates its pioneering technology to help clients improve clinical trial execution, speed time to market and reduce product development costs.
“In just a short time the Mytrus technology has proven to help U.S. sponsors address key challenges that have plagued the industry for decades,” said Michael McKelvey, president, inVentiv Health Clinical Division and executive vice president, inVentiv Health. “Applying this approach globally holds tremendous promise for improving the trial process for sponsors and patients around the world.”
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 Britain’s 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.
