Co-Clinical Trials: An Innovative Drug Development Platform for Cholangiocarcinoma

Pharmaceuticals

Kanokpan Wongprasert¹  Tavan Janvilisri²  Rutaiwan Tohtong²  Supeecha Kumkate³  DavidO. Bates⁴  Brinda Balasubramanian⁵  Simran Venkatraman⁵  KyawZwar Myint⁵ 

[1] Department of Anatomy, Faculty of Science, Mahidol University, Bangkok 10400, Thailand;Department of Biochemistry, Faculty of Science, Mahidol University, Bangkok 10400, Thailand;Department of Biology, Faculty of Science, Mahidol University, Bangkok 10400, Thailand;Division of Cancer and Stem Cells, School of Medicine, Biodiscovery Institute, University of Nottingham, Nottingham NG7 2RD, UK;Graduate Program in Molecular Medicine, Faculty of Science, Mahidol University, Bangkok 10400, Thailand;

关键词: cholangiocarcinoma;    co-clinical trials;    targeted therapy;    clinical trials;    precision medicine;   

DOI  :  10.3390/ph14010051

来源: DOAJ

【 摘 要 】

Cholangiocarcinoma (CCA), a group of malignancies that originate from the biliary tract, is associated with a high mortality rate and a concerning increase in worldwide incidence. In Thailand, where the incidence of CCA is the highest, the socioeconomic burden is severe. Yet, treatment options are limited, with surgical resection being the only form of treatment with curative intent. The current standard-of-care remains adjuvant and palliative chemotherapy which is ineffective in most patients. The overall survival rate is dismal, even after surgical resection and the tumor heterogeneity further complicates treatment. Together, this makes CCA a significant burden in Southeast Asia. For effective management of CCA, treatment must be tailored to each patient, individually, for which an assortment of targeted therapies must be available. Despite the increasing numbers of clinical studies in CCA, targeted therapy drugs rarely get approved for clinical use. In this review, we discuss the shortcomings of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy drugs. The increased availability of targeted therapy drugs for treatment is expected to facilitate the application of precision medicine in CCA.

【 授权许可】

Unknown