September 2020
The COVID-19 pandemic has disrupted thousands of clinical trials worldwide. At the same time, the pandemic has seen an unprecedented reorientation in clinical trials research towards COVID-19. Both of those aspects ensure that the effects of the COVID-19 pandemic will be felt in clinical trials research long after the initial effects have faded:
The biggest supply chain challenge is how to vaccinate the entire world safely, efficiently and fairly. How do we get from formulating, to planning, to manufacturing and finally distributing billions of doses of vaccine:
New PowerPoint report ‹Coronavirus Disease 2019 (COVID-19) Pandemic Impact on Clinical Trials› and the challenges arising from the move toward decentralized clinical trials:
On 27th August, Russia became the first country to register a COVID-19 vaccine, but without publishing clinical data that would prove the vaccine's efficacy. Scientists see downsides to this vaccine, and to other COVID-19 vaccines from China:
So far in the COVID-19 pandemic, surveillance systems are not monitoring ill health and long-term implications of COVID-19, only deaths are reported. Most are also not tracking all cases, only positive tests are counted:
More than 150 coronavirus vaccines are in development. Here are the vaccine prospects that have made it to phase three trials and beyond:
The ‹AI-based Clinical Trial Solution Providers Market, 2020-2030› report studies companies offering AI-based platforms for clinical trial applications, the current market landscape and their future potential:
Now online from DIA, an on-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy:
American Gene Technologies has received the FDA’s approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.
Events organiser Arena International is hosting the ‹Outsourcing in Clinical Trials USA – Virtual Conference› on 30th September - 1st October. Complimentary passes are available for Pharma, Biotech and Medical Devices Companies. For non-biotech, vendor, CRO and service providers the fee is $600 per pass:
arena-international.com/octusavirtual
News on the impact of Brexit on the healthcare sector has taken a back seat to the COVID pandemic. However, preparations still need to be made for post-Brexit regulations. The Medicines & Healthcare Products Regulatory Agency (MHRA) website on gov.uk lists documents chronologically, making it extremely hard to search. We suggest taking a look at the TOPRA site, the membership organisation for individuals working in healthcare regulatory affairs. It has guidance, some available for non-members, on areas such as clinical trials, GLP, and medicine safety:
