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Thursday, February 03, 2022 9:45:11 AM
As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.
on 2021-11-15 last time may very well have had an impact on submitting the article NOT the peer-reviewing.
DI has said mid-Nov they are in peer review how would Covid have such a huge impact on peer-reviewing? No other medical article had delay let alone in peer review time due to Covid. Name one that did?
Like I have said many times now Vubru has said a peer review should take a max of 6 weeks and therefore the article should have landed the first week in January at max. They, therefore, have a delay in the peer-review process.
Its MY OPINION. that they now must see the urgency, pull the article and publish with a less high-tier journal.
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