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Home » Topics » COVID-19

COVID-19
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Remote Monitoring, Protocol Amendments Spike With COVID-19 Spread

April 1, 2020
Brandon May

Protocol changes and deviations may be unavoidable to ensure the safety of trial participants during the COVID-19 crisis, the FDA says in a rare direct-to-final guidance released this week, and sponsors and investigators should examine alternatives to face-to-face trial procedures. 

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Many Investigators Ceasing New Patient Enrollment, Survey Finds

March 29, 2020
A survey conducted by Clinical Research IO has found that 24 percent of investigators across 73 different research sites have stopped new patient enrollment due to concerns about COVID-19. Another 37 percent of investigators who responded to the survey say they are considering ceasing new patient enrollment due to COVID-19 safety concerns. Read More

UK Regulators to Only Conduct Essential Inspections During COVID-19 Outbreak

March 29, 2020
Regulators in the UK will only conduct essential on-site inspections of clinical trials, distribution, laboratories, manufacturing and pharmacovigilance during the COVID-19 outbreak, according to new guidances issued last week. Read More

EMA Guidance Calls for Systematic Planning of Trial Alterations

March 29, 2020
Sponsors of clinical trials in the EU should create a systematic plan for their COVID-19 response that documents reasons for protocol deviations and other trial adjustments, according to a new draft guidance from the EMA. Read More

Global Regulatory Workshop Offers Regulatory Considerations, Data Requirements for Phase 1 COVID-19 Vaccine Trials

March 29, 2020
A meeting report from a regulatory workshop held virtually under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) provides an overview of new regulatory considerations for the development of COVID-19 vaccines and data requirements for phase 1 COVID-19 vaccine trials. Read More

New WCG Webinars Provide Expert Insight on COVID-19’s Impact on Clinical Trials

March 29, 2020
WCG Clinical has launched a weekly webinar series in which panels of experts discuss issues facing clinical trials during the COVID-19 pandemic. Read More

Trial Disruptions Continue to Increase in Wake of Pandemic

March 29, 2020
Sponsors, sites and regulators continue to feel the disruptive effects of the COVID-19 crisis and are scrambling to find solutions, leading to trial delays and enrollment suspensions. Read More

COVID-19 Update

March 29, 2020
COVID-19 Drug Research Roundup Read More
Clinical-Trial-Brainstorming

Patients Can Be Partners in Continuing Clinical Trials During the Pandemic

March 29, 2020
Brandon May
Patient centricity is truly coming to the forefront as sponsors and investigators search for ways to battle the effects of COVID-19 and keep their trials afloat while protecting their participants’ health and safety. Read More
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COVID-19 Operational Challenges Require New Risk Assessments

March 29, 2020
James Miessler
Sponsors and sites must reassess the risks of all their ongoing trials in the face of the COVID-19 pandemic, looking for factors that may increase the severity of already-identified risks and new, unanticipated risks presented by the virus. Read More
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