Open Orphan plc (LON:ORPH), a rapidly growing specialist clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, has confirmed that an editorial opinion piece regarding the UK Government’s Human Challenge Programme has been published in the latest edition of the New England Journal of Medicine (NEJM).
The piece, titled ‘Establishing the Model during an Evolving Pandemic’, explores the extensive preliminary review process which was commissioned by the UK Government and delivered by the coalition involved in the COVID-19 Human Challenge Programme to justify the research and manage and minimise the risks associated with the trial, as well as arguments supporting the inclusion of a SARS-CoV-2 human challenge research program as part of the pandemic response.
The Human Challenge Programme, part of the UK Government’s Vaccine Taskforce, is a collaboration between the UK Government, the Royal Free London NHS Foundation Trust, Imperial College London and hVIVO, a subsidiary of Open Orphan, to deliver the world’s first human challenge study for COVID-19.
In human challenge studies, a small number of healthy volunteers in a controlled setting are exposed to an infectious agent, in this instance, COVID-19, for scientists and clinicians to assess how effective vaccines or treatments are against the disease and identify any side effects.
The NEJM is recognised as the world’s leading medical journal and website. Published continuously for over 200 years, the NEJM delivers high-quality, peer-reviewed research and interactive clinical content to physicians, educators, researchers, and the global medical community. The publication’s mission is to publish the best research and information at the intersection of biomedical science and clinical practice and to present this information in understandable, clinically useful formats that inform health care practice and improve patient outcomes.
Cathal Friel, Executive Chairman of Open Orphan plc, commented: “We are delighted to see support for the COVID-19 Human Challenge Programme in a publication such as the New England Journal of Medicine. The piece articulates the considerable review process commissioned by the UK Government and delivered by hVIVO, in collaboration with the Royal Free London NHS Foundation Trust, and Imperial College London. We believe the UK Government’s COVID-19 Human Challenge Programme will play a vital role in trialling the vaccines and antivirals which continue support our effective pandemic response in the UK and abroad.”