185 related articles for article (PubMed ID: 29663424)
1. Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.
Green DJ; Burnham JM; Schuette P; Liu XI; Maas BM; Yao L; McCune SK; Chen J; van den Anker JN; Burckart GJ
J Clin Pharmacol; 2018 Jul; 58(7):885-890. PubMed ID: 29663424
[TBL] [Abstract][Full Text] [Related]
2. Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.
Zimmerman KO; Smith PB; McMahon AW; Temeck J; Avant D; Murphy D; McCune S
JAMA Pediatr; 2019 Jan; 173(1):60-67. PubMed ID: 30452504
[TBL] [Abstract][Full Text] [Related]
3. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study.
Wallach JD; Ciani O; Pease AM; Gonsalves GS; Krumholz HM; Taylor RS; Ross JS
BMC Med; 2018 Mar; 16(1):45. PubMed ID: 29562926
[TBL] [Abstract][Full Text] [Related]
4. US FDA draft Guidance Standard for Clinical Trial Imaging Endpoints: more than just imaging?
Walovitch RC; Chokron P; Agarwal S
Biomark Med; 2012 Dec; 6(6):839-47. PubMed ID: 23227850
[TBL] [Abstract][Full Text] [Related]
5. Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.
Crider K; Williams J; Qi YP; Gutman J; Yeung L; Mai C; Finkelstain J; Mehta S; Pons-Duran C; Menéndez C; Moraleda C; Rogers L; Daniels K; Green P
Cochrane Database Syst Rev; 2022 Feb; 2(2022):. PubMed ID: 36321557
[TBL] [Abstract][Full Text] [Related]
6. Pediatric and Adult Placebo Response Rates in Placebo-Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012-2020.
Park K; Tran NK; Momper JD; Green DJ; Burckart GJ
J Clin Pharmacol; 2022 Aug; 62(8):970-982. PubMed ID: 35118684
[TBL] [Abstract][Full Text] [Related]
7. Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012-2020.
Green FG; Park K; Burckart GJ
J Clin Pharmacol; 2021 Jun; 61 Suppl 1():S28-S35. PubMed ID: 34185898
[TBL] [Abstract][Full Text] [Related]
8. Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Green DJ; Sun H; Burnham J; Liu XI; van den Anker J; Temeck J; Yao L; McCune SK; Burckart GJ
Clin Pharmacol Ther; 2019 Mar; 105(3):555-557. PubMed ID: 30094815
[TBL] [Abstract][Full Text] [Related]
9. Review of Acute Treatment of Migraine Trial Results With the New FDA Endpoints: Design Implications for Future Trials.
Hindiyeh NA; Kellerman DJ; Schmidt PC
Headache; 2019 May; 59(5):819-824. PubMed ID: 30953576
[TBL] [Abstract][Full Text] [Related]
10. Oblimersen: Augmerosen, BCL-2 antisense oligonucleotide - Genta, G 3139, GC 3139, oblimersen sodium.
Drugs R D; 2007; 8(5):321-34. PubMed ID: 17767397
[TBL] [Abstract][Full Text] [Related]
11. Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial.
Emadi A; Chua JV; Talwani R; Bentzen SM; Baddley J
Trials; 2020 Oct; 21(1):897. PubMed ID: 33115543
[TBL] [Abstract][Full Text] [Related]
12. Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.
Green DJ; Liu XI; Hua T; Burnham JM; Schuck R; Pacanowski M; Yao L; McCune SK; Burckart GJ; Zineh I
Clin Pharmacol Ther; 2018 Nov; 104(5):983-988. PubMed ID: 29218740
[TBL] [Abstract][Full Text] [Related]
13. Pediatric Drug Development Studies for Familial Hypercholesterolemia Submitted to the US Food and Drug Administration Between 2007 and 2020.
Park K; Vishnevetskaya K; Vaidyanathan J; Burckart GJ; Green DJ
J Clin Pharmacol; 2022 Mar; 62(3):397-408. PubMed ID: 34562277
[TBL] [Abstract][Full Text] [Related]
14. Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium.
Fangusaro J; Avery RA; Fisher MJ; Packer RJ; Walsh KS; Schouten-van Meeteren A; Karres D; Bradford D; Bhatnagar V; Singh H; Kluetz PG; Donoghue M; Duke ES
Clin Cancer Res; 2024 Jun; 30(11):2303-2308. PubMed ID: 38358393
[TBL] [Abstract][Full Text] [Related]
15. Lessons learned from independent central review.
Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
16. Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: serious concerns over the reliability of the PLATO trial.
DiNicolantonio JJ; Tomek A
Int J Cardiol; 2013 Oct; 168(4):4076-80. PubMed ID: 23911266
[TBL] [Abstract][Full Text] [Related]
17. Success rates for US and Canadian anticancer drug development efforts in pediatric oncology.
Oliviero E; Kourkopoulos G; Kimmelman J
Pediatr Blood Cancer; 2022 Aug; 69(8):e29534. PubMed ID: 35739610
[TBL] [Abstract][Full Text] [Related]
18. Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies.
Ladanie A; Speich B; Briel M; Sclafani F; Bucher HC; Agarwal A; Ioannidis JPA; Pereira TV; Kasenda B; Hemkens LG
J Clin Epidemiol; 2019 Oct; 114():49-59. PubMed ID: 31158450
[TBL] [Abstract][Full Text] [Related]
19. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
Downing NS; Aminawung JA; Shah ND; Krumholz HM; Ross JS
JAMA; 2014 Jan 22-29; 311(4):368-77. PubMed ID: 24449315
[TBL] [Abstract][Full Text] [Related]
20. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.
Hicks KA; Mahaffey KW; Mehran R; Nissen SE; Wiviott SD; Dunn B; Solomon SD; Marler JR; Teerlink JR; Farb A; Morrow DA; Targum SL; Sila CA; Hai MTT; Jaff MR; Joffe HV; Cutlip DE; Desai AS; Lewis EF; Gibson CM; Landray MJ; Lincoff AM; White CJ; Brooks SS; Rosenfield K; Domanski MJ; Lansky AJ; McMurray JJV; Tcheng JE; Steinhubl SR; Burton P; Mauri L; O'Connor CM; Pfeffer MA; Hung HMJ; Stockbridge NL; Chaitman BR; Temple RJ;
Circulation; 2018 Feb; 137(9):961-972. PubMed ID: 29483172
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
