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Broadening participation in clinical trials
Diversity in clinical trials is critically important. Each new treatment needs to be tested in a broad, diverse population, because men and women of different ancestries have different responses to...
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Correct inference from systematic reviews of RCTs
To gauge the effects of medical interventions, we often use meta-analysis to combine the results of randomized control trials (RCTs). RCTs commonly use odds ratios (ORs) to measure the effect of a...
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Is your activity tracker a medical device?
Activity tracker technology has come a long way. The first Fitbit released in 2009 only measured movement, sleep, and calories burned. In contrast, the Fitbit Ionic smartwatch released in 2017 has a...
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The Role of Crowdsourcing in Research
Crowdsourcing is defined as “a sourcing model in which individuals or organizations obtain goods and services, including ideas and finances, from a large, relatively open and often rapidly evolving...
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How do physicians learn about new medication safety information?
Physicians and other providers are the gatekeepers for prescription medicines; they decide who, under what circumstances, and for how long someone takes one – or several – medicines. But how do...
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Is hydroxychloroquine ready for prime time for COVID-19? Not just yet.
In early April, President Trump, in his daily press briefing, told Americans to take the drug hydroxychloroquine, calling it a “game changer” for people with COVID-19: “I really think they should take...
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Single-arm trials for COVID-19 vaccines
Randomized control trials are the commonly held gold standard clinical trial design. The randomized controlled trial (RCT) is the gold standard of clinical research. However, researchers are...
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Early Access vs. Proven Efficacy: FDA’s Accelerated Approval Process
A recent JAMA article noted that only one-third of new drug approvals through the accelerated approval process by the FDA in the US or the conditional marketing authorization in the EU have shown...
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