The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address new questions, including the use of alternate laboratory or imaging centers, video conferencing and postmarketing requirements.
The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites.The guidance also provides some considerations for sponsors looking to use video conferencing in lieu of participant site visits. Specifically, FDA says that investigators and study personnel should be trained on using telemedicine, and that there should be procedures put in place to protect participant privacy and to confirm the investigators’ and participants’ identities.
Major UK Clinical Trial CATALYST Begins
A trial which will rapidly test new therapies for patients hospitalized due to COVID-19 is opening in Birmingham this week. It is hoped that by using drugs that target the most serious symptoms of the virus, the severity of the disease could be reduced leading to a reduction in the number of patients needing to be admitted to intensive care and ultimately, a reduction in virus related deaths.
In what could be a significant development in the fight against the virus the CATALYST trial will test a series of new drugs, including those already in use for patients with cancer and inflammatory diseases such as rheumatoid arthritis.
CATALYST is a team effort, designed by the Inflammation – Advanced and Cell Therapy Trials Team (I-ACT) at the University of Birmingham’s Cancer Research UK Clinical Trials Unit, working in close partnership with University Hospitals Birmingham (UHB) and the Birmingham National Institute for Health Research Biomedical Research Centre (NIHR BRC) to run the trial. It will be delivered in close collaboration with the Oxford and University College London NIHR BRC’s.
When Can We Expect A Coronavirus Vaccine?
Most health experts agree that the need for a vaccine to prevent COVID-19 is clear.”To return to a semblance of previous normality, the development of SARS-CoV-2 vaccines is an absolute necessity” is how a perspective in Science magazine puts it.
So far, it does seem as though the vaccine will be developed faster than ever before in vaccine history. It took more than two decades to come up with a successful polio vaccine. Federal health officials suggest a COVID-19 vaccine may be ready in a tenth of that time.But there are only some things that you can fast-track, and others, not so much. And even though the Food and Drug Administration is going to be evaluating the various stages of testing with great speed in this case, certain standards must be met: First, you have to prove that a vaccine is safe. Then you need to prove that it generates the immune response you want. And then you need to find out if it actually prevents people from getting sick if they’re exposed to the virus.