scholarly journals Overcoming Barriers to Clinical Trials Cooperation: The Breast International Group Example

2021 ◽  
pp. 1-9
Author(s):  
Martine J. Piccart-Gebhart ◽  
Theodora Goulioti ◽  
Carolyn Straehle ◽  
David Cameron
Keyword(s):  
Clinical Trials ◽  
Patient Involvement ◽  
Academic Research ◽  
Molecular Targets ◽  
Next Generation ◽  
Breast International Group ◽  
International Group ◽  
Umbrella Organization

Clinical trials cooperation is not a luxury; it is a necessity, now more than ever, first in light of the segmentation of tumors according to their molecular targets—which are being matched to an increasing number of competitive drugs—and second because it is the only chance to maintain academic research centered on addressing patients’ needs. In its 21 years of existence, the Breast International Group, an umbrella organization supporting the activities of 54 member groups across six continents, has been confronted with challenges that include (1) keeping trust and motivation within the network; (2) improving the interface between academia and industry; (3) improving patient involvement and trust in clinical trials; and (4) fundraising for noncommercial research. We describe how these challenges have been addressed so far, with the hope of empowering the next generation of clinical investigators.

The next generation of therapy for multiple myeloma: a review of ongoing clinical trials utilizing ClinicalTrials.gov

2018 ◽  
Vol 14 (19) ◽  
pp. 1965-1976 ◽  
Author(s):  
Peter Barth ◽  
Colin Vale ◽  
Alison B Chambers ◽  
John L Reagan
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Next Generation

scholarly journals LICENSED ANTHRAX VACCINES AND EXPERIMENTAL PREPARATIONS AT THE STAGE OF CLINICAL TRIALS

2017 ◽  
pp. 112-126
Author(s):  
N. I. Mikshis ◽  
P. Yu. Popova ◽  
A. P. Semakova ◽  
V. V. Kutyrev
Keyword(s):  
Clinical Trials ◽  
Russian Federation ◽  
Large Scale ◽  
Next Generation ◽  
The World ◽  
High Pathogenicity ◽  
The Russian Federation ◽  
Manufacturing Technologies ◽  
Anthrax Vaccines ◽  
Epidemiological Situation

High pathogenicity of anthrax agent combined with unique insensitivity of its spore forms to environmental stresses class it among extremely dangerous biological agents. Registered and effectively used anthrax vaccines made invaluable contribution to the improvement of epidemiological situation around the world. Nevertheless, neglect of non-specific prophylaxis may result in dramatic scenarios and require large-scale measures on rectification of the consequences. Efforts on the development of next-generation vaccines are aimed at safety build-up, decrease in frequency of administration, and enhancement of manufacturing technologies. The review contains the key information on licensed anthrax vaccines designed for medical use, both in the territory of the Russian Federation and abroad. Among multiple experimental developments emphasized have been preparations manufactured by various biopharmaceutical companies in compliance with GMP standards, at different phases of clinical trials in 2016.

scholarly journals PATH-03. CLINICAL UTILITY OF NEXT GENERATION SEQUENCING IN IDH-WILDTYPE GLIOBLASTOMA: THE DANA-FARBER CANCER INSTITUTE EXPERIENCE

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii164-ii164
Author(s):  
Mary Jane Lim-Fat ◽  
Gilbert Youssef ◽  
Mehdi Touat ◽  
Bryan Iorgulescu ◽  
Eleanor Woodward ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Next Generation Sequencing ◽  
Immune Checkpoint Blockade ◽  
Next Generation ◽  
Single Nucleotide Variants ◽  
Dana Farber Cancer Institute ◽  
Clinical Records ◽  
Ngs Data ◽  
Generation Sequencing

Abstract BACKGROUND Comprehensive next generation sequencing (NGS) is available through many academic institutions and commercial entities, and is incorporated in practice guidelines for glioblastoma (GBM). We retrospective evaluated the practice patterns and utility of incorporating NGS data into routine care of GBM patients at a clinical trials-focused academic center. METHODS We identified 1,011 consecutive adult patients with histologically confirmed GBM with OncoPanel testing, a targeted exome NGS platform of 447 cancer-associated genes at Dana Farber Cancer Institute (DFCI), from 2013-2019. We selected and retrospectively reviewed clinical records of all IDH-wildtype GBM patients treated at DFCI. RESULTS We identified 557 GBM IDH-wildtype patients, of which 227 were male (40.7%). OncoPanel testing revealed 833 single nucleotide variants and indels in 44 therapeutically relevant genes (Tier 1 or 2 mutations) including PIK3CA (n=51), BRAF (n=9), FGFR1 (n=8), MSH2 (n=4), MSH6 (n=2) and MLH1 (n=1). Copy number analysis revealed 509 alterations in 18 therapeutically relevant genes including EGFR amplification (n= 186), PDGFRA amplification (N=39) and CDKN2A/2B homozygous loss (N=223). Median overall survival was 17.5 months for the whole cohort. Seventy-four therapeutic clinical trials accrued 144 patients in the upfront setting (25.9%) and 203 patients (36.4%) at recurrence. Altogether, NGS data for 107 patients (19.2%) were utilized for clinical trial enrollment or targeted therapy indications. High mutational burden (>17mutations/Mb) was identified in 11/464 samples (2.4%); of whom 3/11 received immune checkpoint blockade. Four patients received compassionate use therapy targeting EGFRvIII (rindopepimut, n=2), CKD4/6 (abemaciclib, n=1) and BRAFV600E (dabrafenib/trametinib, n=1). CONCLUSION While NGS has greatly improved diagnosis and molecular classification, we highlight that NGS remains underutilized in selecting therapy in GBM, even in a setting where clinical trials and off-label therapies are relatively accessible. Continued efforts to develop better targeted therapies and efficient clinical trial design are required to maximize the potential benefits of genomically-stratified data.

Minimal residual disease in multiple myeloma: an important tool in clinical trials

2021 ◽  
Vol 16 ◽  
Author(s):  
Alessandro Gozzetti ◽  
Monica Bocchia
Keyword(s):  
Multiple Myeloma ◽  
Clinical Trials ◽  
Minimal Residual Disease ◽  
Residual Disease ◽  
New Drugs ◽  
Next Generation ◽  
Depth Of Response ◽  
Next Generation Sequencing Ngs ◽  
Future Therapy ◽  
Minimal Residual

: Minimal residual disease (MRD) detection represents a great advancement in multiple myeloma. New drugs are now available that increase depth of response. The International Myeloma Working Group recommends the use of next-generation flow cytometry (NGF) or next-generation sequencing (NGS) to search for MRD in clinical trials. Best sensitivity thresholds have to be confirmed, as well as timing to detect it. MRD has proven as the best prognosticator in many trials and promises to enter also in clinical practice to guide future therapy.

Personalizing Oncology: Perspectives and Prospects

2013 ◽  
Vol 31 (15) ◽  
pp. 1904-1911 ◽  
Author(s):  
John Mendelsohn
Keyword(s):  
Clinical Trials ◽  
Molecular Targets ◽  
Targeted Drugs ◽  
Genetic Aberrations ◽  
Patients With Cancer ◽  
Reasonable Cost ◽  
Before And After ◽  
Cancer Medicine ◽  
And Performance ◽  
Selection Of

This article provides an overview of the research, beginning a century ago, that has led to the current use of genomically informed methods for selection of targeted therapies to treat individual patients with cancer—so-called precision cancer medicine. Until 1980, most research on cancer therapy was not targeted in the sense we use the word today. Since then, there has been an acceleration in research identifying genetic and molecular targets and in clinical trials using biomarkers that identify the presence of genetic or molecular markers in a patient's cancer to select appropriate targeted therapy. This approach has been made possible by increased knowledge of the genetic pathogenesis of cancer and by increased capacity to sequence genes and genomes in clinically useful timeframes and at a reasonable cost. However, many challenges and pitfalls remain in selecting optimal targets, interpreting data on genetic aberrations, designing effective targeted drugs and antibodies, dealing with resistance to treatments, identifying appropriate combinations of therapies, and performing the complex clinical trials that are required. Future clinical research with experimental targeted agents is likely to be more informative because of appropriate preselection of patients enrolled onto trials and performance of genetic and molecular studies on specimens of a patient's cancer before and after treatment.

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