test
Thursday, July 11, 2024
HomeHealth LawSingle Arm Trials for FDA Drug Approvals in Oncology – Healthcare Economist

Single Arm Trials for FDA Drug Approvals in Oncology – Healthcare Economist

[ad_1]





These have gotten more and more widespread. Agrawal et al. (2022) use knowledge between 2002-2021, and located that FDA authorised:

…176 new malignant hematology and oncology indications based mostly on single-arm trials, together with 116 accelerated approvals (AAs) and 60 conventional approvals. Total, 87 approvals (49%) had been for brand new molecular entities or authentic biologics and 89 (51%) had been supplemental indication. Response fee (RR) was the commonest finish level used to assist approval in these single-arm trials (173 of 176 [98%]). Of the 116 AAs based mostly on single-arm trials, 45 (38%) fulfilled their postmarketing requirement to confirm medical profit, 61 (52%) are pending verification of profit, and 10 (9%) had been withdrawn from the market as of December 31, 2021.



[ad_2]

RELATED ARTICLES

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Most Popular

Recent Comments