We are analyzing https://link.springer.com/article/10.1186/s13073-022-01102-1.

Title:
Clinical trial design in the era of precision medicine | Genome Medicine
Description:
Recent rapid biotechnological breakthroughs have led to the identification of complex and unique molecular features that drive malignancies. Precision medicine has exploited next-generation sequencing and matched targeted therapy/immunotherapy deployment to successfully transform the outlook for several fatal cancers. Tumor and liquid biopsy genomic profiling and transcriptomic, immunomic, and proteomic interrogation can now all be leveraged to optimize therapy. Multiple new trial designs, including basket and umbrella trials, master platform trials, and N-of-1 patient-centric studies, are beginning to supplant standard phase I, II, and III protocols, allowing for accelerated drug evaluation and approval and molecular-based individualized treatment. Furthermore, real-world data, as well as exploitation of digital apps and structured observational registries, and the utilization of machine learning and/or artificial intelligence, may further accelerate knowledge acquisition. Overall, clinical trials have evolved, shifting from tumor type-centered to gene-directed and histology-agnostic trials, with innovative adaptive designs and personalized combination treatment strategies tailored to individual biomarker profiles. Some, but not all, novel trials now demonstrate that matched therapy correlates with superior outcomes compared to non-matched therapy across tumor types and in specific cancers. To further improve the precision medicine paradigm, the strategy of matching drugs to patients based on molecular features should be implemented earlier in the disease course, and cancers should have comprehensive multi-omic (genomics, transcriptomics, proteomics, immunomic) tumor profiling. To overcome cancer complexity, moving from drug-centric to patient-centric individualized combination therapy is critical. This review focuses on the design, advantages, limitations, and challenges of a spectrum of clinical trial designs in the era of precision oncology.
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Keywords {🔍}

cancer, patients, pubmed, trials, trial, article, google, scholar, clinical, treatment, data, tumor, cas, phase, study, molecular, patient, therapy, drug, oncol, central, clin, precision, advanced, analysis, oncology, randomized, results, lung, targeted, treatments, design, multiple, medicine, profiling, realworld, outcomes, alterations, fda, metastatic, response, tumors, efficacy, based, agents, med, drugs, cancers, development, selected,

Topics {✒️}

gov/regulatory-information/search-fda-guidance-documents/master-protocols-efficient-clinical-trial-design-strategies-expedite-development-oncology-drugs gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-combination-cetuximab-metastatic-colorectal-cancer-braf-v600e-mutation org/media-section/news/news-stories/2018/april-2018/10k-patients/ gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pembrolizumab engagement-program/clinical-outcome-assessments-coas-medical-device-decision-making org/document/users-guide-integrating-patient-reported-outcomes-electronic-health-records gov/drugs/fda-approves-larotrectinib-solid-tumors-ntrk-gene-fusions term=science+37&cond=cancer&draw=2&rank=1 gov/downloads/drugs/guidances/ucm193282 c-met-positive stage iv databases/fda-approves-pembrolizumab-adults clinic search search 1-clinical-trials-precision-medicine-cancer braf-mutant colorectal cancer gov/drugsatfda_docs/nda/2019/125514orig1s014 tumor mutational burden-high i-predict treatment-naive study gov/drugsatfda_docs/label/2021/125514s096lbl tumor-agnostic/genomic-based studies mismatch-repair deficiency real-world evidence program gov/ct2/show/nct02152254 gov/ct2/show/nct02693535 gov/ct2/show/nct03228667 gov/ct2/show/nct04644315 small-cell lung cancer small-cell lung cancer real-world clinical outcome patient-reported outcome measures replicate real-world conditions approximate real-world conditions gov/drugs/drug-approvals fda approves larotrectinib integrating patient-reported outcomes real-world data surrounding colorectal cancer wild-type article download pdf children-tmb-h-solid-tumors von hoff model biomarker-based treatment strategies tumour mutational burden real-world outcome data multiple biomarker-driven substudies lung-map trial aimed lung-map trial exemplifies tissue-agnostic trial design braf v600e mutation small-cell lung cancers real-world clinical setting anti-pd-1 antibody pembrolizumab

Questions {❓}

Estimating the cost of new drug development: is it really 802 million dollars?
Targeted therapies: what have we learned from SHIVA?
What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care?
Gov/ct2/show/NCT02152254?
Gov/ct2/show/NCT02693535?
Gov/ct2/show/NCT04644315?

Schema {🗺️}

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         headline:Clinical trial design in the era of precision medicine
         description:Recent rapid biotechnological breakthroughs have led to the identification of complex and unique molecular features that drive malignancies. Precision medicine has exploited next-generation sequencing and matched targeted therapy/immunotherapy deployment to successfully transform the outlook for several fatal cancers. Tumor and liquid biopsy genomic profiling and transcriptomic, immunomic, and proteomic interrogation can now all be leveraged to optimize therapy. Multiple new trial designs, including basket and umbrella trials, master platform trials, and N-of-1 patient-centric studies, are beginning to supplant standard phase I, II, and III protocols, allowing for accelerated drug evaluation and approval and molecular-based individualized treatment. Furthermore, real-world data, as well as exploitation of digital apps and structured observational registries, and the utilization of machine learning and/or artificial intelligence, may further accelerate knowledge acquisition. Overall, clinical trials have evolved, shifting from tumor type-centered to gene-directed and histology-agnostic trials, with innovative adaptive designs and personalized combination treatment strategies tailored to individual biomarker profiles. Some, but not all, novel trials now demonstrate that matched therapy correlates with superior outcomes compared to non-matched therapy across tumor types and in specific cancers. To further improve the precision medicine paradigm, the strategy of matching drugs to patients based on molecular features should be implemented earlier in the disease course, and cancers should have comprehensive multi-omic (genomics, transcriptomics, proteomics, immunomic) tumor profiling. To overcome cancer complexity, moving from drug-centric to patient-centric individualized combination therapy is critical. This review focuses on the design, advantages, limitations, and challenges of a spectrum of clinical trial designs in the era of precision oncology.
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      headline:Clinical trial design in the era of precision medicine
      description:Recent rapid biotechnological breakthroughs have led to the identification of complex and unique molecular features that drive malignancies. Precision medicine has exploited next-generation sequencing and matched targeted therapy/immunotherapy deployment to successfully transform the outlook for several fatal cancers. Tumor and liquid biopsy genomic profiling and transcriptomic, immunomic, and proteomic interrogation can now all be leveraged to optimize therapy. Multiple new trial designs, including basket and umbrella trials, master platform trials, and N-of-1 patient-centric studies, are beginning to supplant standard phase I, II, and III protocols, allowing for accelerated drug evaluation and approval and molecular-based individualized treatment. Furthermore, real-world data, as well as exploitation of digital apps and structured observational registries, and the utilization of machine learning and/or artificial intelligence, may further accelerate knowledge acquisition. Overall, clinical trials have evolved, shifting from tumor type-centered to gene-directed and histology-agnostic trials, with innovative adaptive designs and personalized combination treatment strategies tailored to individual biomarker profiles. Some, but not all, novel trials now demonstrate that matched therapy correlates with superior outcomes compared to non-matched therapy across tumor types and in specific cancers. To further improve the precision medicine paradigm, the strategy of matching drugs to patients based on molecular features should be implemented earlier in the disease course, and cancers should have comprehensive multi-omic (genomics, transcriptomics, proteomics, immunomic) tumor profiling. To overcome cancer complexity, moving from drug-centric to patient-centric individualized combination therapy is critical. This review focuses on the design, advantages, limitations, and challenges of a spectrum of clinical trial designs in the era of precision oncology.
      datePublished:2022-08-31T00:00:00Z
      dateModified:2022-08-31T00:00:00Z
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         Clinical trials
         Precision oncology
         Personalized medicine
         Real-world data
         Human Genetics
         Metabolomics
         Bioinformatics
         Medicine/Public Health
         general
         Cancer Research
         Systems Biology
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            address:
               name:European University Cyprus, Limassol, Cyprus
               type:PostalAddress
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      affiliation:
            name:The University of Texas MD Anderson Cancer Center
            address:
               name:Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, USA
               type:PostalAddress
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      affiliation:
            name:The University of Texas MD Anderson Cancer Center
            address:
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               type:PostalAddress
            type:Organization
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            address:
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      name:European University Cyprus, Limassol, Cyprus
      name:Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, USA
      name:Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, USA
      name:WIN Consortium, Villejuif, France

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