The Hematology/Oncology PRN and the Pharmaceutical Industry PRN Planning Committee aim to develop an education session focused on translating research into clinical practice in the era of precision medicine, accelerated approvals, and biosimilars. Oncology FDA drug approvals comprised almost 40% of new drug approvals in 2020, consisting largely of biologic medications, targeted therapies, and other expensive therapies. Clinical pharmacists play an essential role in understanding and facilitating the use of these new therapies. Not only does this require clinical pharmacist knowledge of toxicity, drug-interactions, and pharmacology, but an understanding of the current FDA drug approval process and expertise in assessing supporting literature of new approvals. Research design for oncology therapies is unique and has evolved significantly to account for bringing drugs to market expediently, treating rare diseases or genetic subsets of malignancies, and addressing the biosimilar approval processes. Therefore, specific topics of this education session will include 1) exploring current FDA drug approval pathways and 2) understanding and evaluating oncology endpoints and novel clinical trial designs, such as basket and umbrella trials. The purpose of this topic is to provide a contemporary view of the oncology drug approval process and assist clinicians in evaluating how novel drugs integrate into clinical practice.