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 […]
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 […]
Read MoreHow COVID-19 Has Impact Clinical Trial Budgeting
As COVID-19 swept across the United States earlier this year, many research centers found themselves pausing or stopping clinical trials and shifting their work from an office or clinic to their homes. Clinical research staff pivoted their focus to support the COVID-19 response, or to launch critical studies focusing on COVID-19. As some research staff […]
Read MoreInvestigators Face Challenges in Writing Research Protocols in the Age of Remote Working
While some research institutions are slowly re-opening their campuses, many investigators and their staff are still working remotely from home, at least part time. This has had a significant impact on both industry sponsored and investigator initiated clinical trials. Learn how to continue protocol writing even when working remotely. https://bit.ly/2QoW1NW
Read MoreTelehealth, Clinical Research and Informed Consent
By most any measure, one of the biggest impacts that COVID-19 has had on the practice of medicine is the shift toward more telemedicine visits. Although the practice of delivering health services over the phone or the Internet has been around for some time, it wasn’t until the pandemic forced communities to close that clinical […]
Read MoreLessons Learned (so far) in COVID-19
Even as communities start the process of evaluating re-opening, many experts believe that a new normal will be with us for a long time. Physical distancing, face masks and ubiquitous alcohol gel will be part of daily life. The risk of recurrence spikes also looms ahead and threatens a return to stricter “stay at home” […]
Read MoreChart Review Studies During and After a Pandemic
The current global pandemic combined with electronic medical records and data visualization technologies have resulted in unprecedented advances in real-time tracking of SARS-CoV-2, the virus that causes COVID-19, across countries, states and local communities. As the situation evolves, there will be ample opportunity and increased need for both retrospective and prospective COVID-19 research studies that […]
Read MoreBRANY’s IRB and Clinical Trial Services teams stand ready to support institutions and sponsors through COVID-19
Research institutions may need to transfer some or all of their clinical trials as they adjust operations in response to the coronavirus pandemic. BRANY, a national organization that provides IRB review and clinical trial start-up services, announced today that its team of experts is standing ready to support institutions impacted by COVID-19. Extraordinary measures, from […]
Read MorePreparing for COVID-19 Impacts on Research Institutions
The rapidly evolving federal, state and local policies regarding COVID-19 are impacting every walk of life in the United States and around the world. Companies, as well as academic and government researchers, have pivoted their focus on vaccines and possible treatments for the novel coronavirus. Health and research institutions are trying to keep up with […]
Read MoreReporting Changes to Research and Reportable Events due to COVID-19
BRANY IRB is monitoring the COVID-19 epidemic and has been notified that organizations conducting research have implemented guidelines to ensure the health and safety of employees, visitors, patients and research participants. In some cases, such guidelines may impact a research team’s ability to carry out study procedures and visits as required. We recognize that this […]
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