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 […]
Read MoreWhat 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 […]
Read MoreGuide 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 […]
Read MoreBest 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 […]
Read MoreThe 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 […]
Read MoreBRANY 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 […]
Read MoreIs 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 […]
Read MoreTrends: 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 […]
Read MoreIncreasing 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 […]
Read MoreCritical 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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