Hello and happy hump day, readers!
The Food and Drug Administration( FDA) is taking a remarkable pace regarding the use of placebos in clinical stimulant trials.
In new guidance set to be published in the Federal Register on Thursday, the agency proposes that certain patients with serious medical conditions–including some forms of cancer–shouldn’t have to take placebos if there’s a therapy on the market that already tasks.
” Placebos are often used in clinical tests. However, patients contending life-threatening maladies, like certain cancers, shouldn’t be given a placebo when there is a known effective therapy ,” wrote Acting FDA Commissioner Ned Sharpless in a tweet on Wednesday.( Relatedly, Sharpless was the director of the National Cancer Institute prior to his selection as the acting FDA chief .)
” Today’s guidance provides clarity to industry considering our recommendations regarding the use of placebos and advises that they should only be used in select situations or in certain trial design features for patients with cancer ,” he added.
Under the guidance, the FDA states that cancer clinical tests which utilize a placebo should largely be limited to those that involve follow-on, “adjuvant” therapies( i.e. additional treatments lend support to a primary medication regimen ), add-on trials, or studies for cancer kinds which have no currently approved therapies.
One key detail to keep an eye on as the public comment period on the general guidelines inaugurates: Will patients with rare diseases with no approved cares insist the same guidance applies to them?
Read on for the day’s news.
Read more: fortune.com