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Research Community Seeks to Enroll More Minorities in Clinical Trials
Several months of data from the COVID-19 pandemic showed that African Americans and other people of color were disproportionately dying from the disease. Disparities in how COVID-19 affects minority communities highlight long-standing difficulties in achieving health equity in U.S. society, including clinical trials.
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Biometrics Expert Discusses Data Integrity for COVID-19 Clinical Trials
The first remdesivir double-blind, placebo-controlled clinical trial for treating COVID-19 was published recently in Lancet. A member of the trial’s data safety monitoring board is Weichung Shih, PhD. Shih discussed the role of biostatisticians in protecting data integrity for clinical trials and the challenges during the COVID-19 pandemic.
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Enhance Health Literacy Among Study Participants
IRBs can help improve health literacy among potential research participants using several tactics, including asking studies to use plain language in informed consent forms. IRBs can review informed consent and subject recruitment materials to ensure the study information is clear and adheres to regulatory requirements.
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IRB Highlights Standardized and Effective Metrics Model
As IRBs and research programs increasingly seek IRBs of record and form reliance agreements, they will need to know whom to trust. IRBs also need their own performance data to share with sponsors, researchers, and others. The challenge is developing metrics that work and can be used by other IRBs for benchmarking purposes.
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Small IRB Copes with COVID-19 Pandemic Under Limited Budget
Many IRBs have seen clinical trial submissions decline since the COVID-19 pandemic began. Clinical trials also were put on hold. But work at Great Bay Community College — a one-person IRB office — has increased.
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Actions for IRBs Reviewing Vaccine Challenge Trials
As the world looks for a safe and effective vaccine against SARS-CoV-2, IRBs should review the bioethical implications of this type of study design, including assessing risks and benefits.
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Vaccine Challenge Trials Present Ethical Issues to IRBs, HRPPs
Bioethicists and researchers say it may be possible to shorten the typical 15-year-plus vaccine timeline through a challenge trial. In this model, participants receive the study vaccine, the are deliberately exposed to SARS-CoV-2. Safety and efficacy are important, but the risk-benefit balance for study participants is weighed more heavily in favor of the greater public good.
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Research Organizations Face Challenges New and Old
As current studies resume and new studies are approved, IRBs and researchers should keep basic safety and regulatory practices in mind, according to experts on the front lines of human research protection and clinical trials.
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Q&A Part 3: IRBs Learn Positive and Instructional Lessons from Pandemic
IRB experts share the ways in which the pandemic has spurred innovation in their institutions.
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Q&A Part 2: How IRB Leaders Helped Staff, Board Members Cope with Uncertainty
Communication, stress, and anxiety were top concerns for IRB leaders and staff during the early days of the COVID-19 pandemic.