Statistical and Ethical Issues in the Design and Conduct of Phase I and II Clinical Trials of New Anticancer Agents

1993 ◽  
Vol 85 (20) ◽  
pp. 1637-1643 ◽  
Author(s):  
Mark J. Ratain ◽  
Rosemarie Mick ◽  
Richard L. Schilsky ◽  
Mark Siegler
2021 ◽  
Vol 22 (2) ◽  
pp. 813
Author(s):  
Isabel Fernandes ◽  
Cecília Melo-Alvim ◽  
Raquel Lopes-Brás ◽  
Miguel Esperança-Martins ◽  
Luís Costa

Osteosarcoma (OS) is a rare condition with very poor prognosis in a metastatic setting. Basic research has enabled a better understanding of OS pathogenesis and the discovery of new potential therapeutic targets. Phase I and II clinical trials are already ongoing, with some promising results for these patients. This article reviews OS pathogenesis and new potential therapeutic targets.


2012 ◽  
Vol 11 (6) ◽  
pp. 637-640 ◽  
Author(s):  
Constantin N Baxevanis ◽  
Michael Papamichail ◽  
Sonia A Perez

2020 ◽  
Vol 29 (7) ◽  
pp. 723-738
Author(s):  
Luigino Calzetta ◽  
Beatrice Ludovica Ritondo ◽  
Maria Gabriella Matera ◽  
Gabriella Pezzuto ◽  
Mario Cazzola ◽  
...  

Author(s):  
Stephen Leong ◽  
Justin Call ◽  
Alex A. Adjei ◽  
Wells Messersmith

2020 ◽  
pp. 107815522093416
Author(s):  
Jasmine Giani ◽  
Michael B Sawyer ◽  
Carole Chambers

Colorectal cancer is one of the most common malignancies diagnosed in Canada. Currently, adjuvant colorectal cancer treatment primarily includes chemotherapeutic regimens such as FOLFOX6 (5-fluorouracil, leucovorin, oxaliplatin) or CAPOX (capecitabine, oxaliplatin), as well as alternative regimens such as TOMOX (raltitrexed, oxaliplatin). However, the prevalence of drug shortages in today’s society may make these preferred regimens inaccessible. The purpose of this case report is to highlight the tolerability of an alternative adjuvant regimen (pemetrexed plus oxaliplatin) that has undergone both phase I and II clinical trials for the treatment of colorectal cancer. The patient presented in this case report is a 57-year-old female diagnosed with Stage III colon cancer. This patient received seven cycles of pemetrexed plus oxaliplatin and experienced several adverse events, with the majority of them being mild in nature including fatigue and cold dysesthesia. However, the patient also experienced progressive neuropathy which required a dose reduction and subsequent discontinuation of oxaliplatin. Overall, pemetrexed and oxaliplatin’s tolerability seems comparable to other regimens used to treat colorectal cancer and could potentially be an option to consider in the future for alternative treatment of colorectal cancer pending further trials.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9080-9080
Author(s):  
D. Wang ◽  
E. Heath ◽  
A. Powell ◽  
T. Chaperon ◽  
F. LaGrone ◽  
...  

9080 Phase I oncology clinical trials are critical in the oncology drug development process. To protect human subjects, every phase 1 protocol must be approved by an institutional review board (IRB) to assure safety before patient accrual. As the volume and complexity of phase 1 trials have increased, the amount of time spent on IRB protocol reviews have also increased for various reasons. Objectives: 1) Determine the average time spent on protocol approval by IRB at KCI/WSU; 2) Identify potential issues raised by IRB resulting in approval delays; 3) Identify the redundancies for which “standard language” implementation could facilitate future IRB applications thereby expediting approval. Methods: 96 Phase 1 research IRB applications at KCI/WSU between 8/1/2005 and 10/31/2006 were reviewed. These applications were stratified based on submission (new protocol versus amendment) and IRB approval (tabled, provisional or approved) status. Concerns frequently brought up by the IRB were identified. Results: The average and median time spent from initial submission to final approval of all 96 applications were 41.4 days and 43 days, respectively. Forty eight of 96 applications (50%) were provisionally approved from the initial review. Average and median time of obtaining final approval were 52.5 days and 52 days. Nine of 96 (9.4%) protocols were tabled with their average approval 83 days. The most common concerns raised by IRB were risks/benefit issues. These concerns were an even greater approval barrier when protocols involved specialized technologies of molecular therapeutics or complicated study designs. Regulatory policy changes issued by oversight organizations also required “real-time” updates into protocols and consent form amendments. Areas of “standard language” for future IRB applications are being compiled and will be discussed upon presentation. Conclusion: Phase 1 clinical trials are essential to anti-cancer drug development. The complicated ethical issues and science warrant an ongoing constructive collaboration of both parties. Identification of commonalities that delay IRB approval will lead to more expeditious IRB approval not only at our institution, but could also benefit other institutions. No significant financial relationships to disclose.


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