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Guideline on the design and conduct of cystic fibrosis clinical trials: the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN).
De Boeck K, Bulteel V, Tiddens H, Wagner T, Fajac I, Conway S, Dufour F, Smyth AR, Lee T, Sermet I, Kassai B, Elborn S; ECFS-CTN network partners. De Boeck K, et al. Among authors: lee t. J Cyst Fibros. 2011 Jun;10 Suppl 2:S67-74. doi: 10.1016/S1569-1993(11)60010-6. J Cyst Fibros. 2011. PMID: 21658644 Free article.
Speeding up access to new drugs for CF: Considerations for clinical trial design and delivery.
Davies JC, Drevinek P, Elborn JS, Kerem E, Lee T; European CF Society (ECFS) Strategic Planning Task Force on ‘Speeding up access to new 4 drugs for CF’; Amaral MD, de Boeck K, Davies JC, Drevinek P, Elborn JS, Kerem E, Lee T. Davies JC, et al. Among authors: lee t. J Cyst Fibros. 2019 Sep;18(5):677-684. doi: 10.1016/j.jcf.2019.06.011. Epub 2019 Jul 11. J Cyst Fibros. 2019. PMID: 31303382 Free article.
Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis.
Bilton D, Pressler T, Fajac I, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Liu K, McGinnis JP 2nd, Eagle G, Gupta R, Konstan MW; CLEAR-108 Study Group. Bilton D, et al. J Cyst Fibros. 2020 Mar;19(2):284-291. doi: 10.1016/j.jcf.2019.08.001. Epub 2019 Aug 23. J Cyst Fibros. 2020. PMID: 31451351 Free PMC article. Clinical Trial.
Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele.
Middleton PG, Mall MA, Dřevínek P, Lands LC, McKone EF, Polineni D, Ramsey BW, Taylor-Cousar JL, Tullis E, Vermeulen F, Marigowda G, McKee CM, Moskowitz SM, Nair N, Savage J, Simard C, Tian S, Waltz D, Xuan F, Rowe SM, Jain R; VX17-445-102 Study Group. Middleton PG, et al. N Engl J Med. 2019 Nov 7;381(19):1809-1819. doi: 10.1056/NEJMoa1908639. Epub 2019 Oct 31. N Engl J Med. 2019. PMID: 31697873 Free PMC article. Clinical Trial.
Building global development strategies for cf therapeutics during a transitional cftr modulator era.
Mayer-Hamblett N, van Koningsbruggen-Rietschel S, Nichols DP, VanDevanter DR, Davies JC, Lee T, Durmowicz AG, Ratjen F, Konstan MW, Pearson K, Bell SC, Clancy JP, Taylor-Cousar JL, De Boeck K, Donaldson SH, Downey DG, Flume PA, Drevinek P, Goss CH, Fajac I, Magaret AS, Quon BS, Singleton SM, VanDalfsen JM, Retsch-Bogart GZ. Mayer-Hamblett N, et al. Among authors: lee t. J Cyst Fibros. 2020 Sep;19(5):677-687. doi: 10.1016/j.jcf.2020.05.011. Epub 2020 Jun 7. J Cyst Fibros. 2020. PMID: 32522463 Free PMC article. Review.
Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study.
Flume PA, Biner RF, Downey DG, Brown C, Jain M, Fischer R, De Boeck K, Sawicki GS, Chang P, Paz-Diaz H, Rubin JL, Yang Y, Hu X, Pasta DJ, Millar SJ, Campbell D, Wang X, Ahluwalia N, Owen CA, Wainwright CE; VX14-661-110 study group. Flume PA, et al. Lancet Respir Med. 2021 Jul;9(7):733-746. doi: 10.1016/S2213-2600(20)30510-5. Epub 2021 Feb 10. Lancet Respir Med. 2021. PMID: 33581080
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