Surrogate Endpoints: Benefits, Issues And The Future
On a mild day in April 2016, a Marriott Hotel conference room in Hyattsville, Md., was the scene of one of the most politically charged panel meetings the US Food and Drug Administration held in years. A throng of parents and young boys in wheelchairs hoped to convince a committee to endorse the use of a controversial drug for Duchenne muscular dystrophy, a rare and fatal muscle-wasting disease.
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The race to develop COVID-19 vaccines is intensifying long-standing debate over the ability of lower-income countries to gain affordable access to needed medical treatments. Patient advocates argue that drug makers and wealthy governments are striking deals that place poor countries at a disadvantage. The pharmaceutical industry, however, maintains it is moving as quickly as possible to not only discover safe and effective vaccines, but to enable equitable distribution.
Some believe unmet need refers only to rare diseases and tiny patient populations. But it is more than this. In 2020, the term sits at the heart of decision-making for drug makers – along with cost, access and value, of course.
Over the past few years, frustrating instances of shortages and recalls – particularly generics – have been blamed on inferior quality control at countless suppliers of active pharmaceutical ingredients and finished products, especially those based in India and China.