Clinical trials on oncology studies- a review
Abstract
Clinical trials plays major role in making the drug safety and effective for the patients suffering from diseases. Cancer disease is one of the leading causes of deaths. Oncology clinical trials are very crucial for the patients, as this might be the only hope for the survival. However, eligibility criteria decides the patients participating in the trial and all the patients should be screened molecularly. There are certain barriers that shut out the patients from enrolling in the clinical trials. Age, gender, race, family status, literacy also affects the patient’s participation into the trials. Of all the population participating in clinical trials, elderly population represents almost 25-30%. There are different phases in the clinical trials like Phase 1, Phase 2, Phase 3 and Phase 4 with different criteria and different endpoints. Phase 1 aims on safety, phase 2 aims on efficacy, phase 3 aims on the therapeutic effect of drug, whereas phase 4 deals with the long-term effects of the drug in the market.
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References
2. Sharyl J. Nass HLM. Clinical Trials System for the 21st Century Reinvigorating the NCI.; 2010.
3. Polus D. Oncology Trials 101-The Basics and Then Some. 2011;2. http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Patient%2FSubjec t+Recruit
4. Goldberg RM, Wei L, Fernandez S. The Evolution of Clinical Trials in Oncology: Defining Who Benefits from New Drugs Using Innovative Study Designs. Oncologist. 2017;22(9):1015-1019. doi:10.1634/theoncologist.2017-0153
5. Kim ES, Bruinooge SS, Roberts S, et al. Broadening eligibility criteria to make clinical trials more representative: American society of clinical oncology and friends of cancer research joint research statement. Journal of Clinical Oncology. 2017;35(33):3737-3744. doi:10.1200/JCO.2017.73.7916
6. Vivek H. Murthy, MD M, Harlan M. Krumholz, MD S, Cary P. Gross M. Participation in Cancer Clinical Trials Race-, Sex-, and Age-Based Disparities. JAMA. 2004;291(22):2720-2726.
7. Ford JG, Howerton MW, Lai GY, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: A systematic review. Cancer. 2008;112(2):228-242. doi:10.1002/cncr.23157
8. Li A, Bergan RC. Clinical trial design: Past, present, and future in the context of big data and precision medicine. Cancer. 2020;126(22):4838-4846. doi:10.1002/cncr.33205
9. Eisenhauer E, Vermorken JB, Eisenhauer EA. Principles and Process of Cancer Drug Development Breast Cancer View Project Principles and Process of Cancer Drug Development. Vol 34.; 2000. http://www.eud-
10. Verweij J, Hendriks HR, Zwierzina H. Innovation in oncology clinical trial design.Cancer Treat Rev. 2019;74:15-20. doi:10.1016/j.ctrv.2019.01.001
11. Wong KM, Capasso A, Eckhardt SG. The changing landscape of phase I trials in oncology. Nat Rev Clin Oncol. 2016;13(2):106-117. doi:10.1038/nrclinonc.2015.194
12. Ratain MJ, Sargent DJ. Optimising the design of phase II oncology trials: The importance of randomisation. Eur J Cancer. 2009;45(2):275-280. doi:10.1016/j.ejca.2008.10.029
13. Buyse M. Phase III design: Principles. Chin Clin Oncol. 2016;5(1):1-13. doi:10.3978/j.issn.2304-3865.2014.08.05
14. Joseph M. Unger PhD, Willliam E. Barlow PhD, Scott D. Ramsey MD, Michael LeBlanc PhD, Charles D. Blanke MD, Dawn L. Hershman MD. The Scientific Impact of Positive and Negative Phase III Cancer Clinical Trials. JAMA Oncol. 2017;176(5):139-148. doi:10.1001/jamaoncol.2015.6487.The
15. AMERICAN CANCER SOCIETY. Clinical Trials : What You Need to Know. American cancer society. Published online 2020:2-4.
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