Clinical Trials: virtual, remote, or decentralized?

What does it mean to conduct a virtual clinical trial? What about remote, decentralized, hybrid, or siteless studies?  These terms are sometimes used interchangeably. But there may be value in distinguishing how these models can facilitate recruiting subjects and change the way clinical trials have traditionally been conducted. Advances in mobile and digital health technologies […]

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Restarting Research Projects and Programs

The COVID-19 pandemic had significant impacts on clinical trials and research programs. According to researchers at Penn State, over 80 percent of clinical trials were suspended between March 1 and April 26, 2020, mostly due to the pandemic. The impact was more substantial for government or academic-funded studies than for sponsored trials, according to their […]

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A Methodological Approach to Coverage Analysis

To ensure appropriate reimbursement for the services provided to a patient in a clinical trial, research sites must develop a budget for each study. One important step in developing a clinical trial budget is conducting a “coverage analysis,” also known as Medicare Coverage Analysis, sometimes referred to an MCA. An MCA identifies the services for […]

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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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