scholarly journals The PEARRL reviews - innovative drug development strategies tailored to facilitate earlier access to new oral medicines

2019 ◽  
Vol 71 (4) ◽  
pp. 439-440 ◽  
Author(s):  
Brendan T. Griffin ◽  
Jennifer B. Dressman
Keyword(s):  
Drug Development ◽  
Development Strategies ◽  
Innovative Drug

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

2021 ◽  
Vol 14 (1) ◽  
pp. 51
Author(s):  
Brinda Balasubramanian ◽  
Simran Venkatraman ◽  
Kyaw Zwar Myint ◽  
Tavan Janvilisri ◽  
Kanokpan Wongprasert ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Drug Development ◽  
Surgical Resection ◽  
Treatment Options ◽  
Standard Of Care ◽  
Time Data ◽  
Current Standard ◽  
Innovative Drug ◽  
Curative Intent

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.

scholarly journals The path to innovative drug development of cancer vaccine: From discovery of tumor antigens to clinical trials

2014 ◽  
Vol 37 (2) ◽  
pp. 90-95 ◽  
Author(s):  
Toshihiko TORIGOE ◽  
Yoshihiko HIROHASHI ◽  
Tomohide TSUKAHARA ◽  
Takayuki KANASEKI ◽  
Vitaly KOCHIN ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Cancer Vaccine ◽  
Tumor Antigens ◽  
Innovative Drug
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