Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Kassa Ayalew"'
Autor:
Darya Kizub, Cathyryne K. Manner, Katy Graef, Bello Abubakar, Jackson Orem, Folakemi Odedina, Mojisola Christianah Adeyeye, Gertrude Nakigudde, Kassa Ayalew, Chitkala Kalidas, Herbert Kim Lyerly, Thea Norman, Lola Fashoyin-Aje, Jamie Freedman, Jennifer Dent, Bill Cance, Julie Gralow
Publikováno v:
JCO Global Oncology, Vol , Iss 8 (2022)
Patients of African ancestry are not well-represented in cancer clinical trials despite bearing a disproportionate share of mortality both in United States and Africa. We describe key stakeholder perspectives and priorities related to bringing early-
Externí odkaz:
https://doaj.org/article/c70bdb1e2e38445683572079d0ce2509
Autor:
Jenn W, Sellers, Camelia M, Mihaescu, Kassa, Ayalew, Phillip D, Kronstein, Bei, Yu, Yang-Min, Ning, Miguel, Rodriguez, LaKisha, Williams, Ni A, Khin
Publikováno v:
Therapeutic Innovation & Regulatory Science. 56:753-764
Background The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7f0f27ed2b6243ec45eb936076aa3cd9
https://doi.org/10.1007/s43441-022-00417-w
https://doi.org/10.1007/s43441-022-00417-w
Autor:
Kassa Ayalew, Jenn Sellers, Phillip D. Kronstein, Laurie Muldowney, Emily Gebbia, Jean Mulinde, David Burrow
Publikováno v:
Journal of the Society for Clinical Data Management. 2
The COVID-19 public health emergency limited the U.S. Food and Drug Administration’s ability to conduct on-site good clinical practice (GCP) inspections. Alternative tools have been used by the FDA during the pandemic to evaluate the reliability an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1f2257f79fc15272f4a21cf9e4e18264
https://doi.org/10.47912/jscdm.216
https://doi.org/10.47912/jscdm.216
Autor:
Phillip D. Kronstein, Jean Mulinde, Ni A. Khin, Seongeun-Julia Cho, Arindam Dasgupta, Cheryl Grandinetti, Gail Francis, Kassa Ayalew, Stephen Vinter, Jason Wakelin-Smith, Rachel Skeete, Bei Yu, Andrew Fisher, Paula Walker, Mandy Budwal-Jagait, Cynthia Kleppinger, Jennifer Martin, Michael McGuinness, Hayley Dixey
Publikováno v:
Clinical Pharmacology & Therapeutics. 112:31-43
With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::745066f63e6896fb319ecf5978f3d83a
https://doi.org/10.1002/cpt.2386
https://doi.org/10.1002/cpt.2386
Autor:
Kassa Ayalew, Yang-Min Ning, Michelle J. Foringer, Susan Leibenhaut, Jenn Sellers, Bei Yu, Phillip D. Kronstein, Agata Higgerson, Camelia Mihaescu, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
Background The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::57d6a76c14b31a947cc06ce510955afe
https://doi.org/10.21203/rs.3.rs-1667001/v1
https://doi.org/10.21203/rs.3.rs-1667001/v1
Autor:
Bei Yu, Stephen Vinter, Phillip D. Kronstein, Rachel Skeete, Jean Mulinde, Cheryl Grandinetti, Arindam Dasgupta, Ruben C. Ayala, Seongeun‐Julia Cho, Ni A. Khin, Andrew Fisher, Gail Francis, Kassa Ayalew, Cynthia Kleppinger, Charles Bonapace
Publikováno v:
Clinical Pharmacology & Therapeutics. 108:949-963
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in cli
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fa102910e1afefdd1ed1b366114f3c46
https://doi.org/10.1002/cpt.1794
https://doi.org/10.1002/cpt.1794
Autor:
Jenn W. Sellers, Camelia M. Mihaescu, Kassa Ayalew, Phillip D. Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
Publikováno v:
Therapeutic Innovation & Regulatory Science. 56:765-766
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6976a55420e44dd0a81f1c26b76b9c96
https://doi.org/10.1007/s43441-022-00423-y
https://doi.org/10.1007/s43441-022-00423-y
Autor:
Jenn W. Sellers, Camelia M. Mihaescu, Kassa Ayalew, Phillip D. Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
Publikováno v:
Therapeutic Innovation & Regulatory Science. 56:767-767
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::caf78523f287db5646f03fc02b732909
https://doi.org/10.1007/s43441-022-00427-8
https://doi.org/10.1007/s43441-022-00427-8
Autor:
Kassa Ayalew, Hildy Dillon, Patricia LoRusso, Eric H. Rubin, Michael Cecchini, Gregory H. Reaman, Michele Russell-Einhorn, Gideon M. Blumenthal, Scott A. Boerner, H. Kim Lyerly, Howard A. Burris
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research. 25(7)
The 2018 Accelerating Anticancer Agent Development (AAADV) Workshop assembled a panel of experts for an in-depth discussion session to present “Challenges with Novel Clinical Trial Designs.” This panel offered assessments of the challenges faced
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a620882c04517c0965e3efe70e79e6e
https://pubmed.ncbi.nlm.nih.gov/30696689
https://pubmed.ncbi.nlm.nih.gov/30696689
Autor:
Kassa Ayalew, Richard L. Piekarz, Kevin A. Prohaska, Ni A. Khin, Joanne R. Less, Sandra A. Mitchell, Janice Kim, Elektra J. Papadopoulos, Michelle Campbell, Harpreet Singh, Alyson Karesh, Paul G. Kluetz, Susan Thompson, Rajeshwari Sridhara, Laura Lee Johnson, Lori Minasian, Jerry Menikoff, Richard Pazdur, Kristina Borror
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research. 24(8)
Cancer therapeutics frequently lead to symptomatic adverse events (AE) that can affect treatment tolerability. The NCI has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess sym
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8a028be72b44dcae457d00d95849a342
https://pubmed.ncbi.nlm.nih.gov/29437788
https://pubmed.ncbi.nlm.nih.gov/29437788