Hallek Michael, Cheson Bruce D, Catovsky Daniel, Caligaris-Cappio Federico, Dighiero Guillaume, Döhner Hartmut, Hillmen Peter, Keating Michael J, Montserrat Emili, Rai Kanti R, Kipps Thomas J
Klinik I für Innere Medizin, Universität zu Köln, Köln, Germany.
Blood. 2008 Jun 15;111(12):5446-56. doi: 10.1182/blood-2007-06-093906. Epub 2008 Jan 23.
Standardized criteria for diagnosis and response assessment are needed to interpret and compare clinical trials and for approval of new therapeutic agents by regulatory agencies. Therefore, a National Cancer Institute-sponsored Working Group (NCI-WG) on chronic lymphocytic leukemia (CLL) published guidelines for the design and conduct of clinical trials for patients with CLL in 1988, which were updated in 1996. During the past decade, considerable progress has been achieved in defining new prognostic markers, diagnostic parameters, and treatment options. This prompted the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) to provide updated recommendations for the management of CLL in clinical trials and general practice.
需要标准化的诊断和反应评估标准来解释和比较临床试验,并供监管机构批准新的治疗药物。因此,一个由美国国立癌症研究所赞助的慢性淋巴细胞白血病(CLL)工作组(NCI-WG)在1988年发布了CLL患者临床试验设计和实施的指南,并于1996年进行了更新。在过去十年中,在确定新的预后标志物、诊断参数和治疗选择方面取得了相当大的进展。这促使慢性淋巴细胞白血病国际研讨会(IWCLL)为临床试验和一般临床实践中CLL的管理提供更新的建议。