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Next-generation methods for early disease detection in crops.
Pest Manag Sci
February 2024
Department of Biology, University of Florence, Florence, Italy.
Plant pathogens are commonly identified in the field by the typical disease symptoms that they can cause. The efficient early detection and identification of pathogens are essential procedures to adopt effective management practices that reduce or prevent their spread in order to mitigate the negative impacts of the disease. In this review, the traditional and innovative methods for early detection of the plant pathogens highlighting their major advantages and limitations are presented and discussed.
View Article and Find Full Text PDFLooking ahead in early-phase trial design to improve the drug development process: examples in oncology.
BMC Med Res Methodol
June 2023
Department of Data Science, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02115, USA.
Background: Clinical trial design must consider the specific resource constraints and overall goals of the drug development process (DDP); for example, in designing a phase I trial to evaluate the safety of a drug and recommend a dose for a subsequent phase II trial. Here, we focus on design considerations that involve the sequence of clinical trials, from early phase I to late phase III, that constitute the DDP.
Methods: We discuss how stylized simulation models of clinical trials in an oncology DDP can quantify important relationships between early-phase trial designs and their consequences for the remaining phases of development.
Prospectively shared control data across concurrent randomised clinical trials.
Eur J Cancer
March 2023
Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Data Science, Dana-Farber Cancer Institute, Boston, MA, USA.
Sharing data from control groups across concurrent randomised clinical trials with identical enrolment criteria and the same control therapy can translate into efficiencies for the drug development process. We discuss potential benefits and risks of prospective data-sharing plans for concurrent randomised trials.
View Article and Find Full Text PDFNovel Clinical Trial Designs in Neuro-Oncology.
Neurotherapeutics
October 2022
Department of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA.
Scientific and technologic advances have led to a boon of candidate therapeutics for patients with malignancies of the central nervous system. The path from drug development to clinical use has generally followed a regimented order of sequential clinical trial phases. The recent increase in novel therapies, however, has strained the regulatory process and unearthed limitations of the current system, including significant cost, prolonged development time, and difficulties in testing therapies for rarer tumors.
View Article and Find Full Text PDFEvaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial.
Trials
September 2021
Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.
Background: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB.
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