RANDOMIZATION IS AN INFREQUENTLY USED METHOD IN INTERVENTIONAL PHASE II CLINICAL TRIALS OF ADULT PATIENTS WITH LYMPHOMA

Introduction: Clinical trials are important to inform decision making and improve outcomes for patients with lymphoma. Phase II designed determine if a new treatment has enough promising efficacy safety warrant further investigation in phase III trial. Randomized controlled have historically received the greatest consideration providing reliable evidence of drug's efficacy. However, Single Arm Non-Randomized Studies (SANRS) been considered as valid option by regulators. It reported that 66% (49/74) approvals granted between 1999 2014 from European Medicines Agency (EMA) U.S. Food Drug Administration (FDA) were based on nonrandomized experiments oncology including hematological malignancies, lymphoma is one most common cancer types single arm FDA drug approval. The aim this report evaluate proportion evolution time use randomization interventional clinical adult lymphoma, using sample ClinicalTrials.govdatabase. Methods: We conducted predefined search United States National Library Medicine database (ClinicalTrials.gov) field “condition or disease” term "lymphoma" filters "interventional studies", "phase 2 studies” “adults = >18–64 years old” plus “older adults 65 older”. examined all met inclusion criteria January 1st, 2012, through December 31st, 2022. excluded overlapping terminology did not enroll mature lymphoid neoplasms, such precursor b-lymphoblastic lymphoma/leukaemia, anaplastic kinase (ALK) non-small-cell lung involving very broad disease categories “advanced cancer”, “hematological malignancies” “high risk populations” exception when significant was expected be enrolled. Difficult cases discussed decided at discretion authors. Results: Our returned 2085 trials, those we included 1376 analysis according our inclusion/exclusion criteria. found 2012 2022 performed 12.8% (177/1376) histogram (Figure 1) shows number increased during period, but randomized remained proportionally low. Keywords: therapeutics other No conflicts interests pertinent abstract.