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Showing 1–17 of 17 results
Advanced filters: Author: Jonathan Kimmelman Clear advanced filters

  • Ethical review boards must focus on clinical promise as well as safety to hold the first tests of drugs in humans to a higher standard, say Jonathan Kimmelman and Carole Federico.

    • Jonathan Kimmelman
    • Carole Federico
    Comments & Opinion
    Nature
    Volume: 542, P: 25-27

  • New guidelines from the International Society for Stem Cell Research offer a model for self-regulation in contentious areas, write Jonathan Kimmelman and colleagues.

    • Jonathan Kimmelman
    • Insoo Hyun
    • George Q. Daley
    Comments & Opinion
    Nature
    Volume: 533, P: 311-313

  • The application of gene therapy to treat human disorders has made many advances in recent years, although many ethical challenges associated with this type of intervention remain unresolved. This Perspective describes the special challenges posed by research in this field.

    • Jonathan Kimmelman
    Comments & Opinion
    Nature Reviews Genetics
    Volume: 9, P: 239-244

  • Many argue that phase I cancer trials are a therapeutic option for eligible patients. I question this position and offer a more nuanced view that differentiates between types of trials. Patients seeking treatment might legitimately pursue phase I trials, although labelling all phase I trials as therapeutic contradicts the spirit of evidence-based medicine.

    • Jonathan Kimmelman
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 16, P: 719-720

  • New molecular insights occasionally lead to the rapid development of therapeutic agents that improve the outcomes of patients with cancer; however, these breakthroughs can be followed by extensive, empirically driven and often unsuccessful efforts at extending the drug to other indications or combinations. Herein, we describe the clinical development of imatinib, a paradigm of rapid molecularly driven drug development, and advocate for a balanced portrayal of the potential of molecularly targeted therapies for cancer.

    • Benjamin G. Carlisle
    • Tiger Zheng
    • Jonathan Kimmelman
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 17, P: 1-3

  • According to the paradigm of precision medicine, the administration of agents targeting the molecular alteration detected in a particular patient’s tumour reduces uncertainty in the clinical management of that patient. We describe how approaches to precision medicine can lead, paradoxically, to increased levels of uncertainty. We offer recommendations for how physicians can better navigate new uncertainties in precision medicine.

    • Jonathan Kimmelman
    • Ian Tannock
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 15, P: 341-342

  • In April 2021, Eli Lilly voluntarily asked the FDA to revoke the Emergency Use Authorization for the monoclonal antibody bamlanivimab due to reduced susceptibility in vitro to SARS-CoV-2 variants, not for safety. In this work, authors carry out a placebo-controlled phase 2 evaluation of bamlanivimab in non-hospitalized adults with COVID-19, to determine safety and efficacy.

    • Kara W. Chew
    • Carlee Moser
    • Davey M. Smith
    ResearchOpen Access
    Nature Communications
    Volume: 13, P: 1-12

  • In this Perspective, the authors discuss the ethical challenges of individualized therapy (also called n-of-1) trials and argue that, although customized for the patient, these constitute ‘research’ nonetheless.

    • Patrick Bodilly Kane
    • Merlin Bittlinger
    • Jonathan Kimmelman
    Reviews
    Nature Medicine
    Volume: 27, P: 1679-1686

  • The clinical translation of stem-cell-based therapeutic interventions has its own ethical and policy challenges requiring collaboration among wide-ranging stakeholders.

    • Amanda MacPherson
    • Jonathan Kimmelman
    Reviews
    Nature Medicine
    Volume: 25, P: 1037-1044