Replies to post #226852 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Basket Studies: An Innovative Approach for Oncology Trials
JULY 02, 2018

https://www.pharmacytimes.com/contributor/ryan-chandanais-ms-cpht/2018/07/basket-studies-an-innovative-approach-for-oncology-trials

[biosectinvestor]

Advances in the molecular genetics of gliomas — implications for classification and therapy

https://www.nature.com/articles/nrclinonc.2016.204?WT.feed_name=subjects_biological-sciences

[biosectinvestor]

Basket Trials for Intractable Cancer

https://www.frontiersin.org/articles/10.3389/fonc.2019.00229/full

Currently, genomic characterization has become standard of care for tumor types such as non-small cell lung cancer, breast cancer, melanoma, and colorectal cancer. A deep understanding of genomic alterations in different tumor types would help identify potentially actionable genomic changes which occur across a wide variety of tumor types. A basket trial is a new type of clinical trial for which eligibility is based on the presence of a specific genomic alteration, irrespective of histology. Basket trials are phase II screening trials for the off-label use of a targeted drug in patients with the same genomic alterations for which it was approved. Intractable cancer refers to a type or condition of cancer which is unresponsive or resistant to treatment; intractable cancers may be classified into five subtypes as follows: hard-to-treat condition of common advanced cancer after multiple-line therapy, rare cancer in which no standard of care has been recommended, advanced cancer in which standard of care does not work well, cancer accompanied with organ dysfunction, and cancers in older or younger cancer patients. Previous studies have demonstrated that in basket trials, genomic-guided therapy yields clinical benefits in intractable cancer, thereby providing novel insights into the optimal clinical management of such cancers. In this review, we describe a novel way to classify intractable cancer, and summarize the current knowledge on such cancers. We additionally provide information on the role of basket trials in intractable cancer.

[biosectinvestor]

Master protocol trials in oncology: Review and new trial designs

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6120722/

Abstract

In oncology, next generation sequencing and comprehensive genomic profiling have enabled the detailed classification of tumors using molecular biology. However, it is unrealistic to conduct phase I–III trials according to each sub-population based on patient molecular subtypes. Common protocols that assess the combination of several molecular markers and their targeted therapies by means of multiple sub-studies are required. These protocols are called “master protocols,” and are drawing attention as a next-generation clinical trial design. Recently, several reviews of clinical trials based on the master protocol design have been published, but their definitions of these such trials, including basket, umbrella, and platform trials, were not consistent. Concurrently, the acceleration of the development of new statistical designs for master protocol trials has been underway. This article provides an overview of recent reviews for master protocols, including their statistical design methodologies in Oncology. We also introduce several examples of previous and on-going master protocol trials along with their classifications by some recent studies.

Keywords: Master protocol, Basket, Umbrella, Platform, Bayesian adaptive method

[maverick_1]

Thank you BioSelect for pointing this out!

I was aware since your 1st post on this classification that NWBO’s DC VAX DIRECT would be under this classification.

DIFFERENT STROKES FOR DIFFERENT FOLKS

[biosectinvestor]

Efficiencies of platform clinical trials: A vision of the future

https://journals.sagepub.com/doi/abs/10.1177/1740774515626362?journalCode=ctja

Abstract
Background:
A “platform trial” is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. Adaptive platform designs offer flexible features such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during the course of a trial.

Methods:
A simulation study explores the efficiencies of various platform trial designs relative to a traditional two-arm strategy.

Results:
Platform trials can find beneficial treatments with fewer patients, fewer patient failures, less time, and with greater probability of success than a traditional two-arm strategy.

Conclusion:
In an era of personalized medicine, platform trials provide the innovation needed to efficiently evaluate modern treatments.