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Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Khin NA, Grandinetti C, Dixey H, Yu B, Skeete R, Ayalew K, Budwal-Jagait M, Cho SJ, Dasgupta A, Fisher A, Kleppinger C, Kronstein PD, Martin J, McGuinness M, Mulinde J, Vinter S, Wakelin-Smith J, Walker P, Francis G. Khin NA, et al. Among authors: grandinetti c. Clin Pharmacol Ther. 2022 Jul;112(1):31-43. doi: 10.1002/cpt.2386. Epub 2021 Aug 30. Clin Pharmacol Ther. 2022. PMID: 34358334
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Khin NA, Francis G, Mulinde J, Grandinetti C, Skeete R, Yu B, Ayalew K, Cho SJ, Fisher A, Kleppinger C, Ayala R, Bonapace C, Dasgupta A, Kronstein PD, Vinter S. Khin NA, et al. Among authors: grandinetti c. Clin Pharmacol Ther. 2020 Nov;108(5):949-963. doi: 10.1002/cpt.1794. Epub 2020 Mar 28. Clin Pharmacol Ther. 2020. PMID: 31958142
New FDA regulation to improve safety reporting in clinical trials.
Sherman RB, Woodcock J, Norden J, Grandinetti C, Temple RJ. Sherman RB, et al. Among authors: grandinetti c. N Engl J Med. 2011 Jul 7;365(1):3-5. doi: 10.1056/NEJMp1103464. Epub 2011 Jun 8. N Engl J Med. 2011. PMID: 21651388 Free article. No abstract available.
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative.
Coran P, Goldsack JC, Grandinetti CA, Bakker JP, Bolognese M, Dorsey ER, Vasisht K, Amdur A, Dell C, Helfgott J, Kirchoff M, Miller CJ, Narayan A, Patel D, Peterson B, Ramirez E, Schiller D, Switzer T, Wing L, Forrest A, Doherty A. Coran P, et al. Among authors: grandinetti ca. Digit Biomark. 2019 Nov 6;3(3):145-154. doi: 10.1159/000503957. eCollection 2019 Sep-Dec. Digit Biomark. 2019. PMID: 32095773 Free PMC article.
Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review.
Perry B, Herrington W, Goldsack JC, Grandinetti CA, Vasisht KP, Landray MJ, Bataille L, DiCicco RA, Bradley C, Narayan A, Papadopoulos EJ, Sheth N, Skodacek K, Stem K, Strong TV, Walton MK, Corneli A. Perry B, et al. Among authors: grandinetti ca. Digit Biomark. 2018 Jan 31;2(1):11-30. doi: 10.1159/000486347. eCollection 2018 Jan-Apr. Digit Biomark. 2018. PMID: 29938250 Free PMC article. Review.
Tapered oral dexamethasone for the acute chest syndrome of sickle cell disease.
Quinn CT, Stuart MJ, Kesler K, Ataga KI, Wang WC, Styles L, Smith-Whitley K, Wun T, Raj A, Hsu LL, Krishnan S, Kuypers FA, Setty Y, Rhee S, Key NS, Buchanan GR; Investigators of the Comprehensive Sickle Cell Centers. Quinn CT, et al. Br J Haematol. 2011 Oct;155(2):263-7. doi: 10.1111/j.1365-2141.2011.08827.x. Epub 2011 Aug 16. Br J Haematol. 2011. PMID: 21848879 Free PMC article. Clinical Trial.
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