28 May 2020 – For immediate release
Since the emergence of the novel coronavirus SARS-CoV-2 and the WHO declaration of a pandemic, there has been a rapid expansion in the number of COVID-19 related clinical studies. Whilst many studies are being carried out to internationally accepted high standards, there are some that are small, not well controlled and may be unlikely to deliver robustly interpretable results. Whilst this has been recognised and commented upon by WHO and regulatory authorities worldwide, there remain many ethical, practical and financial implications of this.
The Faculty of Pharmaceutical Medicine (FPM) has been increasingly aware of these issues, and in order to support the effort and provide clarity and encourage consistency, today launches the Principles for Clinical Studies into COVID-19 guidance document.
The guidance outlines, clearly and concisely, the key principles that should be adhered to when developing and implementing trials in COVID-19. It has been developed by a small team of FPM members, experts in clinical trial design.
The guidance is principally aimed at trial sponsors, investigators, ethics committees and journal editors. It covers issues of governance, trial design across different phases and types, consent, statistical considerations and requirements for regulatory engagement and independent adjudication.
Commenting on the launch of the guidance:
Professor Tim Higenbottam, President of the Faculty of Pharmaceutical Medicine, said:
“The public expects that both the public health measures to limit the spread of the pandemic of COVID-19 disease and the response and outputs of the academic community and health science industries, are based upon robust scientific evidence. Demonstration that medicines are effective takes time and we should not forget the enormous contribution made by the patients and healthy participants when volunteering for clinical trials. The FPM offers these principles in part to remind us all about the care we should take when designing and undertaking clinical trials at this time of great public anxiety.”
Dr Stuart Dollow, lead author of the guidance and Board member and trustee of the FPM, said:
“COVID-19 is a public health emergency, where evidence-based guidelines from well designed and conducted studies are urgently needed. The urgency of a pandemic should not distract us from undertaking high quality research, but act as a prompt to ensure it is undertaken with due care and attention. All of us as researchers owe it to patients, their families and friends, as well as the wider population, to ensure that recommendations relating to COVID-19 are based on good evidence. We have a responsibility to protect patients from studies that potentially deny patients access to effective therapies or cause them harm. The FPM principles provide a framework for sponsors and investigators in the design of their studies and for those who review and approve them as a standard to assess them against.”
Notes for Editors
Please contact Ben Cottam, Head of Policy and Communications, for more information:
020 3696 9034 / 07912 600 645