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To better clarify the IRBs position in investigating clinical investigators and sites for clinical trials, the Food and Drug Administration (FDA) has released draft guidance for reviewing those qualifications.
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A new study has found that while nine out of 10 clinical trials worldwide meet enrollment goals, reaching those goals could mean doubling original timelines.
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It is a natural electronic data evolution: First, IRBs began using electronic data systems; then these morphed into full electronic submission, and now IRBs are collecting valuable electronic, real-time data that can be mined very quickly for process and quality improvement purposes. Metrics are key to this transition.
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IRBs and human research protection staff engage in important, sometimes life-protecting work. Their purpose and goals are on high ethical and moral ground. So its easy to forget that its also an enterprise with clients or customers to satisfy.
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Informed consent documents remain long and complex, despite successful efforts in recent years to improve their readability, an expert reports.
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In order to protect human subjects and the integrity of research, everyone involved should adhere to ethics guidelines and must adhere to ethics and compliance standards.
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A study by Canadian researchers shows that many published breast cancer studies are biased to show a positive outcome.
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Low-income cancer patients, including those who are on Medicare, are far less likely to participate in clinical trials than higher-income patients, according to a study in the Journal of Clinical Oncology.
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When an IRB initiates electronic metrics collection and analyses as part of its quality improvement process, there will be obstacles to overcome.
