Im­prov­ing can­cer drug re­search: FDA re­works and fi­nal­izes guid­ance doc­u­ments

To align with Pres­i­dent Biden’s re­newed push around his Can­cer Moon­shot project, the FDA on Tues­day re­leased new guid­ance to com­pa­nies spon­sor­ing on­col­o­gy tri­als and fo­cused on two im­por­tant con­cepts — mas­ter pro­to­cols (a long-time Janet Wood­cock fa­vorite) and ex­pan­sion co­horts — while FDA al­so em­pha­sized how tri­als should in­clude par­tic­i­pants over 75 years old.

The 24-page fi­nal guid­ance on mas­ter pro­to­cols, build­ing on a draft from Oc­to­ber 2018, ex­plains how to run these tri­als in­tend­ed to si­mul­ta­ne­ous­ly eval­u­ate more than one in­ves­ti­ga­tion­al drug and/or more than one can­cer type with­in the same tri­al struc­ture.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER