Pandemic-related Mental Health Care Needs Continue to Increase, Highlighting the Need for More Social-Behavioral Research

A report[1] published last week by the Centers for Disease Control & Prevention (CDC) shows an increase in anxiety, depression and people’s need for mental health services. According to the survey, between August 2020 and February 2021, the percentage of adults with recent symptoms of an anxiety or a depressive disorder increased from 36.4 percent […]

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What is the DSMB and Why You Should Know

The Data and Safety Monitoring Board (DSMB) established to monitor COVID-19 vaccines this week announced they were reviewing the clinical trial data submitted by Astra Zeneca for their COVID-19 vaccine. But what is a DSMB, and why is it important for clinical research sites to know? A Data and Safety Monitoring Board (DSMB) is an […]

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Guide to Remote Audits

The United States reached the one-year anniversary of the first confirmed case of COVID-19, on January 15. Even now, as the rollout of vaccinations is underway, institutions are still facing campus and facility closures. We cannot underestimate the impact of COVID-19 on clinical trials and the research community. Institutions have had to refocus resources toward […]

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Best Practices for Remote IRB Meetings

The campus closures necessitated by the pandemic in 2020 forced many research administration officials to adopt virtual meetings to continue their work. People scrambled to set up their home offices, to secure Wi-Fi networks and create accounts on videoconferencing services. The Internet offered dozens of articles on how to improve online meetings to encourage engagement […]

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The Importance of Real-time Data and Safety Monitoring

Researchers at Baylor College of Medicine Houston announced this week that they were stopping a clinical trial investigating the efficacy of convalescent plasma therapy in the treatment of patients with COVID-19. The reason, according to the principal investigator, was that statisticians had deemed the NIH-funded study to be futile. In other words, even with more […]

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BRANY Announces Integrated Service for Sponsored Clinical Research Studies

End-to-end solution is designed to help hospitals and institutions attract and administer sponsored clinical research studies (Lake Success, NY) — BRANY today announced the launch of CTrials, an innovative end-to-end solution that offers a clinical trials administrative support service focused on helping hospitals and institutions accelerate their research goals. CTrials by BRANY is built around […]

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Is Your Institution Prepared to Identify Exempt Research?

The disruption of clinical research as a result of COVID-19 cannot be overstated. Virtually everything about developing protocols and starting clinical trials has been upturned. In some cases, trials have been closed indefinitely. Others have been delayed or streamlined. Much of the interaction, such as IRB review meetings, has been shifted online, decentralized or outsourced […]

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Trends: What We Are Watching in 2021

We know we are not alone when we say we are happy to put 2020 behind us. It was a challenging year for everyone, and we look forward to better days ahead. Despite the difficulties that the research community faced, we witnessed remarkable flexibility, resilience and creativity in dealing with significant hurdles. Last year lent […]

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Increasing Diversity in Clinical Trials

The FDA issued guidance in November aimed at enhancing diversity and encouraging inclusivity in medical research, specifically in the development of medical products. FDA Commissioner Stephan M. Hahn, M.D., wrote that “in order to promote public health, it is important that people who are in clinical trials represent the populations likely to use the potential medical […]

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Critical Considerations for Remote Clinical Trials

Even as research centers and academic institutions re-open after shutdowns due to COVID-19, many researchers are looking at ways to use remote technologies in their clinical trials. In South Carolina, for example, nicotine addiction researchers[1] are examining how to enroll smokers in their studies. They are evaluating e-consents, online surveys and questionnaires, as well as […]

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