https://www.nsf.org/knowledge-library/oncology-clinical-trials-an-emerging-paradigm-shift-in-trial-design
Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design November 20, 2020 Cancer treatment has made significant strides toward the promise of personalized medicine.

https://www.youtube.com/watch?v=Jj2Ke024NJ0
Cancer treatments, are fulfilling the promises of personalized medicine, especially using genetic biomarkers in cancer cells. This webinar reviews several ne

https://www.nsf.org/gb/en/knowledge-library/oncology-clinical-trials-an-emerging-paradigm-shift-in-trial-design
Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design. November 20, 2020. Cancer treatment has made significant strides toward the promise of personalized medicine. This webinar focuses on the different clinical trial strategy options. LinkedIn Logo; Facebook Logo; Twitter Logo; How NSF Can Help You

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099154/
Abstract. Clinical trials represent a fulcrum for oncology drug discovery and development to bring safe and effective medicines to patients in a timely manner. Clinical trials have shifted from traditional studies evaluating cytotoxic chemotherapy in largely histology-based populations, to become adaptively designed and biomarker driven

https://www.amarexcro.com/resources/oncology-clinical-trials-study-design
This white paper explains the different study designs for clinical trials and the emergence of master protocols as a way to simultaneously evaluate multiple drugs and/or disease populations in multiple studies. Find out the key features of master protocol trial designs, including the practical and statistical challenges associated with designs of this type.

https://www.nature.com/articles/s41591-023-02466-6
These organizations have proposed a new research paradigm that assumes patients to be eligible for clinical trials by default, and encourages investigators to start protocol development with

https://pubmed.ncbi.nlm.nih.gov/33811119/
Clinical trials have shifted from traditional studies evaluating cytotoxic chemotherapy in largely histology-based populations to become adaptively de … The Future of Clinical Trial Design in Oncology Cancer Discov. 2021 Apr;11(4):822-837. doi: 10.1158/2159-8290.CD-20-1301.

https://www.youtube.com/watch?v=Ic_hAyXmPo4
Cancer treatments are fulfilling the promises of personalized medicine. One aspect is the use of biomarkers detectable in blood such as circulating tumor cel

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7693060/
Introduction. The goal of clinical trials in cancer drug development is to improve clinically meaningful outcomes for patients. The result of a clinical trial has the potential to shape the care of many future patients, to alter our understanding of human biology, and to produce long‐lasting financial ramifications for health care and industry.

https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.1002/cncr.33205
change in clinical trial design. Herein, we provide a review of cancer clinical trial designs; we begin with a historical perspective, which is followed by a discussion of new directions. Emphasis is placed on precision therapeutics and emerging concepts and technologies in oncol-ogy and how they are transforming the clinical trial landscape.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6695130/
A possible explanation for the exceedingly high cost of bringing cancer drugs to the market, compared to other disease-type drugs, is in part due to the level of complexity and length of time required to conduct phase III cancer clinical trials . These increasing costs could have led to a change in clinical trial design that looks for

https://www.sciencedirect.com/science/article/pii/S0305737219300040
Regulatory agents and innovative clinical trial design. For regulators, RCTs remain the gold standard to evaluate the benefit-risk ratio of cancer drugs, but early clinical trials offer opportunities for early access to the market. The EMA has approved drugs based on early clinical trial data since 1995 on a case-by-case basis.

https://www.nsf.org/ca/en/knowledge-library/oncology-clinical-trials-an-emerging-paradigm-shift-in-trial-design
Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design. November 20, 2020. Cancer treatment has made significant strides toward the promise of personalized medicine. This webinar focuses on the different clinical trial strategy options. LinkedIn Logo; Facebook Logo; Twitter Logo; How NSF Can Help You

https://www.nsf.org/in/en/knowledge-library/oncology-clinical-trials-an-emerging-paradigm-shift-in-trial-design
Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design Cancer treatment has made significant strides toward the promise of personalized medicine. This webinar focuses on the different clinical trial strategy options.

https://trinitylifesciences.com/wp-content/uploads/2021/05/Oncology_Basket_Trials_-_Trinity_Partners-1.pdf
nificant shift in treatment approaches remainsan open question. The growing pool of mid-phase/ exploratory tissue-agnostic trials suggests we could be headed in that direction, leading to many long-term implications on the clinical application, commercialization. ent of targeted oncolytics in the next severa.

https://ascopubs.org/doi/10.14694/EdBook_AM.2015.35.3
Ivy SP, Siu LL, Garrett-Mayer E, et al. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res. 2010;16:1726-1736.

https://www.thelancet.com/series/cancer-trial-design
Executive Summary. Clinical trial design in oncology is undergoing constant refinement as clinicians, pharmaceutical companies, and other stakeholders seek to improve patient selection, data analysis and interpretation, and trial reporting, in the shared hope of offering the most effective treatments to patients with cancer as quickly and

https://www.amarexcro.com/resources/oncology-clinical-trials-an-emerging-paradigm-shift-in-trial-design
This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints. Cancer treatments are fulfilling the promises of personalized medicine. One aspect is the use of biomarkers detectable in blood such as circulating tumor cells. This webinar reviews several newer clinical trial

https://onlinelibrary.wiley.com/doi/10.1002/pst.2287
Not only does the early phase oncology research paradigm need to change to embrace more efficient designs, a refocusing to include study designs that estimate the Optimal Biological Dose (OBD), as appropriate, is needed; for example, the BOIN12 8 or TITE-BOIN12 9 study designs. This premise also aligns with regulators who are encouraging

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646634/
Translating research into clinical practice is a challenging and valuable skill for the advanced practitioner (AP) in oncology. Recent analysis of 585 trials registered in the National Cancer Institute Clinical Trials database showed that 29% remained unpublished within 5 years of completion of the study (Jones et al., 2013).A second study showed that among 1,075 abstracts describing 378

https://pubmed.ncbi.nlm.nih.gov/32031692/
Abstract. With advancements in biomarkers and momentum in precision medicine, biomarker-guided trials such as basket trials and umbrella trials have been developed under the master protocol framework. A master protocol refers to a single, overarching design developed to evaluate multiple hypotheses with the general goal of improving the

https://aacrjournals.org/cancerdiscovery/article/11/4/822/665844/The-Future-of-Clinical-Trial-Design-in
AbstractClinical trials represent a fulcrum for oncology drug discovery and development to bring safe and effective medicines to patients in a timely manner. Clinical trials have shifted from traditional studies evaluating cytotoxic chemotherapy in largely histology-based populations to become adaptively designed and biomarker-driven evaluations of molecularly targeted agents and immune

https://researchinvolvement.biomedcentral.com/articles/10.1186/s40900-024-00599-7
Background In light of the FDA's Project Optimus initiative, there is fresh interest in leveraging Patient-reported Outcome (PRO) data to enhance the assessment of tolerability for investigational therapies within early phase dose-finding oncology trials. Typically, dose escalation in most trial designs is solely reliant on clinician assessed adverse events. Research has shown a disparity

https://journals.sagepub.com/doi/full/10.1177/10732748241264704
The space of treatment options available to cancer patients is ever expanding, fueling the drive for treatment optimizations that involve combining multiple types of drugs either sequentially or concurrently to overcome acquired resistance and hedge against minimal residual disease. 1,2 There are more than 27, 000 clinical trials currently registered in CinicalTrials.org for combination cancer

https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33205
In conclusion, the clinical trial is a fundamental part of oncology. The traditional phase 1 to 3 trial paradigm has defined the vast majority of our current standard-of-care treatments. However, with the rapid development of novel therapeutics and biomarkers, a different strategy is opening up before us and is being put into practice.

https://www.mdpi.com/1422-0067/25/13/6967
However other clinical trials combining a TKI with an ICI failed to demonstrate efficacy over standard-of-care in MSS CRC patients, ... M.F.; Chen, L. A Paradigm Shift in Cancer Immunotherapy: From Enhancement to Normalization. Cell 2018, 175, 313-326. ... Results of the DAPPER Clinical Trial. Clin. Cancer Res. 2023,

https://www.ohsu.edu/sites/default/files/2024-06/OCTRI_PDF_BIP_Awardees_2024.06.20.pdf
effectively reduced angiographic vasospasm failed to improve clinical outcome. This led to a shift in focus from DCI to early ... approached elimination of TKI liabilities by combining our drug design paradigm with cardiomyocytes derived from induced ... radiotracers have been tested in early -phase clinical trials in pancreatic cancer, however

https://jnanobiotechnology.biomedcentral.com/articles/10.1186/s12951-024-02630-1
Lipid nanoparticles (LNPs) have proven themselves as transformative actors in chimeric antigen receptor (CAR) T cell therapy, surpassing traditional methods and addressing challenges like immunogenicity, reduced toxicity, and improved safety. Promising preclinical results signal a shift toward safer and more effective CAR T cell treatments. Ongoing research aims to validate these findings in