{"title":"Challenges in biomarker-based clinical trials for patients with gastrointestinal malignancies","authors":"J. Kratz, Wei Zhang, M. Patel, N. Uboha","doi":"10.1080/23808993.2022.2106852","DOIUrl":null,"url":null,"abstract":"ABSTRACT Introduction The goal of precision oncology is to match each patient with the most appropriate therapeutic agent based on patient- and tumor-specific characteristics. Many therapeutics in development target tumors with specific biomarkers, in addition to considering tumor histologic classification and clinical presentation. Areas Covered Appropriate patient selection for research studies is critical to elucidate the potential effectiveness of therapies in development, as well as to spare the toxicities from ineffective therapies in patients who are unlikely to benefit. Biomarker-based clinical studies provide a platform to bring forward the expanse of therapeutics beyond the use of chemotherapy, including novel immunotherapeutic and targeted strategies. There are a number of issues to be considered when developing these types of studies. They range from biomarker validity to patient enrollment and trial availability. In this review, we discuss challenges that are frequently confronted in the design, enrollment, and analysis of biomarker-based clinical trials for patients with gastrointestinal (GI) cancers. Expert opinion The challenges encountered in biomarker-based trials for patients with GI cancers must be considered and addressed early during drug development to ensure proper therapy and patient selection in a timeframe acceptable for both patient diseases and rapidly changing oncology standards.","PeriodicalId":12124,"journal":{"name":"Expert Review of Precision Medicine and Drug Development","volume":"7 1","pages":"121 - 130"},"PeriodicalIF":1.0000,"publicationDate":"2022-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Precision Medicine and Drug Development","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/23808993.2022.2106852","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
ABSTRACT Introduction The goal of precision oncology is to match each patient with the most appropriate therapeutic agent based on patient- and tumor-specific characteristics. Many therapeutics in development target tumors with specific biomarkers, in addition to considering tumor histologic classification and clinical presentation. Areas Covered Appropriate patient selection for research studies is critical to elucidate the potential effectiveness of therapies in development, as well as to spare the toxicities from ineffective therapies in patients who are unlikely to benefit. Biomarker-based clinical studies provide a platform to bring forward the expanse of therapeutics beyond the use of chemotherapy, including novel immunotherapeutic and targeted strategies. There are a number of issues to be considered when developing these types of studies. They range from biomarker validity to patient enrollment and trial availability. In this review, we discuss challenges that are frequently confronted in the design, enrollment, and analysis of biomarker-based clinical trials for patients with gastrointestinal (GI) cancers. Expert opinion The challenges encountered in biomarker-based trials for patients with GI cancers must be considered and addressed early during drug development to ensure proper therapy and patient selection in a timeframe acceptable for both patient diseases and rapidly changing oncology standards.
期刊介绍:
Expert Review of Precision Medicine and Drug Development publishes primarily review articles covering the development and clinical application of medicine to be used in a personalized therapy setting; in addition, the journal also publishes original research and commentary-style articles. In an era where medicine is recognizing that a one-size-fits-all approach is not always appropriate, it has become necessary to identify patients responsive to treatments and treat patient populations using a tailored approach. Areas covered include: Development and application of drugs targeted to specific genotypes and populations, as well as advanced diagnostic technologies and significant biomarkers that aid in this. Clinical trials and case studies within personalized therapy and drug development. Screening, prediction and prevention of disease, prediction of adverse events, treatment monitoring, effects of metabolomics and microbiomics on treatment. Secondary population research, genome-wide association studies, disease–gene association studies, personal genome technologies. Ethical and cost–benefit issues, the impact to healthcare and business infrastructure, and regulatory issues.