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 therapeutic value. Many of these drugs are high cost, and this begs the question if we are spending our health care dollars appropriately. … Read More »
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 increasingly asking: must they be? Webster-Clark, Jonsson Funk, and Stürmer discussed single-arm trials: administering a drug to an experimental group and using real-world data (RWD) to select an… Read More »
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 it. But it’s their choice. And it’s their doctor’s choice or the doctors in the hospital. But hydroxychloroquine. Try it, if you’d like.”… Read More »
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 physicians stay abreast of the latest research about the safety and efficacy of the medicines they prescribe? We set out to understand how they… Read More »
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 group of internet users. Crowdsourcing spreads work among participants to achieve a cumulative result.” Some well-known examples of crowdsourcing include the online encyclopedia Wikipedia, the traffic… Read More »
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 much broader range of functions, including heart rate monitoring, personal coaching, and built-in GPS. Consequently, with this change in functionality comes a change in potential uses for… Read More »
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 given intervention on the frequencies of events. Conventional methods of estimating overall ORs suffer from a number of issues. Drs. Chang and Hoaglin describe… Read More »
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 both diseases and treatments. If only certain groups of people participate in clinical trials, it can increase disparities and worsen outcomes for people underrepresented in the clinical trial data. Until… Read More »