expanded access

(redirected from Expanded access trial)

expanded access

Any of several methods used by the FDA to make experimental treatments available to patients who have failed conventional treatments and are not participating in formal clinical trials.
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When pirfenidone, which had been tested here since 2002, was approved by the FDA in 2014, patients with ideopathic pulmonary fibrosis from as far away as Kentucky and Philadelphia came to Sarasota to participate in an expanded access trial at SMH.
Other options for patients with metastatic or advanced RCC (31-34) Therapy Rationale Sunitinib Based on subgroup analyses from the Expanded Access trial showing safety and activity Sorafenib Based on subgroup analyses from the ARCCS Expanded Access trial showing safety and activity Temsirolimus Based on subgroup analysis of phase III data RCC: renal cell carcinoma; ARCCS: Advanced Renal Cell Carcinoma Sorafenib.
These data are consistent with the experience in the Bevacizumab Expanded Access Trial (BEAT) [2] and with data from the MD Anderson Cancer Center presented by Kesmodel in 2007 [3].
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