FDA un­veils 5 guid­ances on broad­en­ing can­cer clin­i­cal tri­al el­i­gi­bil­i­ty

As part of a push to trans­form clin­i­cal tri­al el­i­gi­bil­i­ty cri­te­ria that have been ac­cept­ed over time with­out a clear sci­en­tif­ic or clin­i­cal ra­tio­nale, the FDA on Tues­day pub­lished four draft guid­ance doc­u­ments on can­cer clin­i­cal tri­al el­i­gi­bil­i­ty cri­te­ria and one fi­nal guid­ance on in­clud­ing ado­les­cents in adult on­col­o­gy tri­als.

The four drafts, de­vel­oped by the FDA with in­put from the Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy and Friends of Can­cer Re­search, fo­cus on min­i­mum age for pe­di­atric pa­tients; pa­tients with HIV, he­pati­tis B or C virus­es; pa­tients with or­gan dys­func­tion or pri­or or cur­rent ma­lig­nan­cies; and pa­tients with brain metas­tases.

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