Výsledky vyhledávání - "Translational Research, Design and Analysis"

Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs

Autor: Tyler Collier Vandivort, David Bradley Horton, Steven Barton Johnson

Publikováno v: Journal of Clinical and Translational Science

The last three decades have seen the biotherapeutic drug market evolve from promising concept to market dominance in a range of clinical indications. This growth has been spurred by the success of established drug classes like monoclonal antibodies,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::455a417672212c9fc313a7909b254353
https://doi.org/10.1017/cts.2020.493

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Pregnancy health in POWERMOM participants living in rural versus urban zip codes

Autor: Lauren Ariniello, Jill Waalen, Michael Galarnyk, Shaquille Peters, Shannon Wongvibulsin, Jennifer M. Radin, Steven R. Steinhubl

Publikováno v: Journal of Clinical and Translational Science

Background:Pregnant women living in rural locations in the USA have higher rates of maternal and infant mortality compared to their urban counterparts. One factor contributing to this disparity may be lack of representation of rural women in traditio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0fe671943ccf14a4821885773c33571b
http://europepmc.org/articles/PMC7681139

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Guidelines for Data Acquisition, Quality and Curation for Observational Research Designs (DAQCORD)

Autor: Ramona Hicks, Ari Ercole, Jilske A Huijben, Mary J. Vassar, Lindsay Wilson, Vibeke Brinck, Pradeep George, Mike Jarrett

Publikováno v: Journal of Clinical and Translational Science

Background:High-quality data are critical to the entire scientific enterprise, yet the complexity and effort involved in data curation are vastly under-appreciated. This is especially true for large observational, clinical studies because of the amou

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2d07ae60cc7d467cf2994cf0bca87e5f
https://doi.org/10.1017/cts.2020.24

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Designs and methods for implementation research: Advancing the mission of the CTSA program

Autor: Soohyun Hwang, Cathy L. Melvin, Justin D. Smith, Sarah A. Birken, Catherine L. Rohweder

Publikováno v: Journal of Clinical and Translational Science

Introduction:The US National Institutes of Health (NIH) established the Clinical and Translational Science Award (CTSA) program in response to the challenges of translating biomedical and behavioral interventions from discovery to real-world use. To

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::94d3906d53ed7e1a2baa525910e7fd17
https://doi.org/10.1017/cts.2020.16

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Outcomes associated with scale-up of the Stepping On falls prevention program: A case study in redesigning for dissemination

Autor: Jill Renken, Ronald E. Gangnon, LaVerne Jaros, Sandy Cech, Lindy Clemson, Jane E. Mahoney

Publikováno v: Journal of Clinical and Translational Science

Introduction:Translating complex behavior change interventions into practice can be accompanied by a loss of fidelity and effectiveness. We present the evaluation of two sequential phases of implementation of a complex evidence-based community worksh

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ef0512e87f493d3faacef9eda0eca096
http://europepmc.org/articles/PMC7348035

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Facilitating collaborative animal research: The development and implementation of a Master Reciprocal Institutional Agreement for Animal Care and Use

Autor: David E. Goldberg, Kathryn Holthaus, Barbara E. Bierer, Brian Corning, Elizabeth Witte, Carolyn Connelly, Christina Nascimento

Publikováno v: Journal of Clinical and Translational Science

Ensuring appropriate review, approval, and oversight of research involving animals becomes increasingly complex when researchers collaborate across multiple sites. In these situations, it is important that the division of responsibilities is clear an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c488a5da90c3c885ac9e8b4b2e351ae3
https://doi.org/10.1017/cts.2019.431

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Guidance for biostatisticians on their essential contributions to clinical and translational research protocol review

Autor: Heidi Spratt, Lori Lyn Price, Christopher J. Lindsell, Jody D. Ciolino, Todd W. Rice, Susan M. Perkins, Paul J. Nietert, Shari Messinger Cayetano, Brad H. Pollock, Cathie Spino, Walter T. Ambrosius, Robert A. Oster, Gina-Maria Pomann, Shokoufeh Khalatbari, Jodi Lapidus, Tor D. Tosteson

Publikováno v: Journal of Clinical and Translational Science

Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantita

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c6f33c7a94f04010669fc9439439ad18
http://europepmc.org/articles/PMC8427547

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Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response

Autor: Sarah E. Brewer, Elaine H. Morrato, Elizabeth J. Campagna

Publikováno v: Journal of Clinical and Translational Science

Purpose:Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as re

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0234b5b74cce179841cd90b377530a7c
https://doi.org/10.1017/cts.2019.400

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