The development of innovative wearable technologies has raised great interest in new means of data collection in healthcare and biopharmaceutical research and development. Multiple applications for ...wearables have been identified in a number of therapeutic areas; however, researchers face many challenges in the clinic, including scientific methodology as well as regulatory, legal, and operational hurdles. To facilitate further evaluation and adoption of these technologies, we highlight methodological and logistical considerations for implementation in clinical trials, including key elements of analytical and clinical validation in the specific context of use (COU). Additionally, we provide an assessment of the maturity of the field and successful examples of recent clinical experiments.
The replication crisis in the social and psychological sciences is said to be due in part to publication bias and the resulting file drawer problem. Meta-analysis is often advocated as a means of ...resolving this crisis but is prone to the same publication bias and file drawer effects. A study of 23 meta-analyses examined the consequences of correcting for these effects through the inclusion of unpublished research. Results indicated that the inclusion of unpublished data led to smaller meta-analytic means in some instances, consistent with the primary theorized effects of the file drawer problem and publication bias, but led to larger meta-analytic means in nearly as many instances, suggesting the presence and influence of other, unknown artifacts in unpublished research. These findings suggest that meta-analysis is limited in its ability to resolve the replication crisis and instead may introduce unexplained effects that render cumulative science problematic.
Celotno besedilo
Dostopno za:
BFBNIB, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
A meta-analysis reported in this article compared the effects of ontological and utilitarian measures of individualism and collectivism on the findings of published research. Ontological differences ...in individualism and collectivism concern the degree to which either individuals or collectivities are interpreted as the primary entities comprising social reality. Reflecting these differences are measures that include subjects such as the degree of permanence and sense of collective obligation associated with interpersonal, group, or community relationships. Utilitarian distinctions in individualism and collectivism involve beliefs that either individuals or collectivities are instrumental in the pursuit of valued outcomes. Related measures include items concerning the attractiveness or consequences of working alone versus working in a group. Results of the meta-analysis indicated that ontological and utilitarian measures have produced differing findings in several notable instances, with utilitarian measures producing larger effects.
Patients with early-stage estrogen-receptor–positive, node-negative breast cancer whose 21-gene Oncotype DX profile suggested a low risk of recurrence were safely treated with endocrine therapy alone ...and were spared exposure to adjuvant chemotherapy.
Breast cancer is the most common cancer in women worldwide and in the United States, and it is the leading cause of death from cancer in women worldwide.
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Prognostic factors for the recurrence of breast cancer at a distant site regardless of treatment include clinicopathologic features such as tumor size and grade and the number of axillary lymph nodes with metastasis.
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Predictive factors that identify a benefit from specific therapies include the expression of the estrogen receptor and the progesterone receptor, which identifies patients who benefit from adjuvant endocrine therapy,
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and overexpression of the human epidermal growth factor receptor 2 . . .
When a genetic test was used to assess prognosis, women with midrange scores were found to have similar outcomes after adjuvant treatment with either endocrine therapy alone or chemotherapy plus ...endocrine therapy.
This engaging collection of over 60 primary document selections sheds light on the personalities, issues, events, and ideas that defined and shaped life in England during the years of Shakespeare's ...life and career. Documents of Shakespeare's England contains more than 60 primary document selections that will help readers understand all aspects of life in Elizabethan and Jacobean England. The book is divided into 12 topical sections, such as Politics and Parliament, London Life, and Queen and Court, which offer five document selections each. Each document is preceded by a detailed introduction that puts the selection into historical context and explains why it is important. A general introduction and chronology help readers understand Shakespeare's England in broad terms and see connections, causes, and consequences. Bibliographies of current and useful print and electronic information resources accompany each document, and a general bibliography lists seminal works on Shakespeare's England. This is an engaging and accurate introduction to the England of William Shakespeare told in the words of those who experienced it.
The strategic, fit-for-purpose use of the combination of robust target engagement and well-qualified disease-related biomarkers enhances understanding of the mechanism of action, ties together ...preclinical and clinical data, enables the assessment of target engagement, facilitates early proof of concept and dose focusing, and increases the efficiency of early clinical development with improved quality of decision making. Significant progress in biomarker discovery, validation, and qualification has increased drug-development decision making and regulatory applications. Target engagement biomarkers are present early in a pathophysiologic cascade and inform on physical or biological interactions with the molecular target of the drug. Disease-related biomarkers are present late in the pathophysiologic cascade and are linked to clinical benefit; thus, they assess a drug's effect on a particular disease. Together, these concepts lay the groundwork for high-quality drug-development decision making and a framework for the acceptance and qualification of biomarkers for regulatory use.
Patient‐Centered Reverse Translation Wagner, John A.
Clinical pharmacology and therapeutics,
February 2018, 2018-02-00, 20180201, Letnik:
103, Številka:
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Journal Article
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