DAVIS, CA. - August 27, 2015 - Mytrus, a technology and services company revolutionizing clinical trials, announced today that 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 was also the first electronic informed consent technology approved for use in a clinical trial by the U.S. Food and Drug Administration 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 UK trial 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 oversees 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 around the globe traditionally have 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® 2.0 iOS software platform uses a tablet device to give potential participants a trial overview that includes simple, entertaining videos to reinforce key information. People 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 counseling and dedicate time for each potential study participant to discuss the study with site staff before agreeing to sign consent.
The UK study using Mytrus' Enroll® 2.0 iOS software platform and web portal began enrolling patients in July. It is being conducted by a top-ten, global pharmaceutical company to determine the safety of a new investigational drug. The e-Consent pilot is being run in tandem with traditional paper consent so that results can be compared.
An independent study conducted by the California Pacific Medical Center Research Institute using Enroll® found that patients provided with paper-only consent were able to correctly answer 58 percent of the questions asked on a follow up questionnaire versus those who used an electronic application and could correctly answer 75 percent of the questions. Drug companies seeking ways to manage soaring development costs can look to Mytrus technology to increase efficiency and improve the patient enrollment experience.
In addition, Mytrus Enroll® provides a variety of significant benefits in improving site performance, with the ability to expedite study start times and enhance regulatory compliance. The technology provides insights to improve relationship management with trial sites and allow sponsors to offer richer, deeper information to regulatory authorities at every step on the path from trial to commercialization.
Mytrus technology has been used by 8 out of the world's 10 largest pharmaceutical companies to improve patient enrollment in clinical trial. Most recently, Mytrus was selected for a pilot project by the oncology clinics at New York-Presbyterian/Weill Cornell Medical Center's Joint Clinical Trials Office. They will use Mytrus' Enroll® to streamline the enrollment process for doctors and researchers, and enable them to track consent status for future research.
Founded in 2009, Mytrus is a privately held e-clinical technology company specializing in patient-centered electronic informed consent and data collection tools. After receiving the first FDA approvals for remote electronic consent and virtual data collection, Mytrus has gone on to develop new technologies for patients including ePRO and EDC tools usable from home and mobile devices, bio-sample consent tracking technology, site training and e-learning applications, and patient home dashboards for tracking clinical study progress and data. Mytrus also holds an exclusive patent for conducting virtual clinical trials in the US. Mytrus investors include BioClinica and inVentiv Health.