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How to design a dose-finding study using the continual reassessment method.
Wheeler GM, Mander AP, Bedding A, Brock K, Cornelius V, Grieve AP, Jaki T, Love SB, Odondi L, Weir CJ, Yap C, Bond SJ. Wheeler GM, et al. Among authors: bond sj. BMC Med Res Methodol. 2019 Jan 18;19(1):18. doi: 10.1186/s12874-018-0638-z. BMC Med Res Methodol. 2019. PMID: 30658575 Free PMC article.
Protocol of the adaptive study of IL-2 dose frequency on regulatory T cells in type 1 diabetes (DILfrequency): a mechanistic, non-randomised, repeat dose, open-label, response-adaptive study.
Truman LA, Pekalski ML, Kareclas P, Evangelou M, Walker NM, Howlett J, Mander AP, Kennet J, Wicker LS, Bond S, Todd JA, Waldron-Lynch F. Truman LA, et al. BMJ Open. 2015 Dec 8;5(12):e009799. doi: 10.1136/bmjopen-2015-009799. BMJ Open. 2015. PMID: 26646829 Free PMC article. Clinical Trial.
Regulatory T Cell Responses in Participants with Type 1 Diabetes after a Single Dose of Interleukin-2: A Non-Randomised, Open Label, Adaptive Dose-Finding Trial.
Todd JA, Evangelou M, Cutler AJ, Pekalski ML, Walker NM, Stevens HE, Porter L, Smyth DJ, Rainbow DB, Ferreira RC, Esposito L, Hunter KM, Loudon K, Irons K, Yang JH, Bell CJ, Schuilenburg H, Heywood J, Challis B, Neupane S, Clarke P, Coleman G, Dawson S, Goymer D, Anselmiova K, Kennet J, Brown J, Caddy SL, Lu J, Greatorex J, Goodfellow I, Wallace C, Tree TI, Evans M, Mander AP, Bond S, Wicker LS, Waldron-Lynch F. Todd JA, et al. PLoS Med. 2016 Oct 11;13(10):e1002139. doi: 10.1371/journal.pmed.1002139. eCollection 2016 Oct. PLoS Med. 2016. PMID: 27727279 Free PMC article. Clinical Trial.
The DILfrequency study is an adaptive trial to identify optimal IL-2 dosing in patients with type 1 diabetes.
Seelig E, Howlett J, Porter L, Truman L, Heywood J, Kennet J, Arbon EL, Anselmiova K, Walker NM, Atkar R, Pekalski ML, Rytina E, Evans M, Wicker LS, Todd JA, Mander AP, Bond S, Waldron-Lynch F. Seelig E, et al. JCI Insight. 2018 Oct 4;3(19):e99306. doi: 10.1172/jci.insight.99306. JCI Insight. 2018. PMID: 30282826 Free PMC article. Clinical Trial.
Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes.
Wilhelm-Benartzi CS, Miller SE, Bruggraber S, Picton D, Wilson M, Gatley K, Chhabra A, Marcovecchio ML, Hendriks AEJ, Morobé H, Chmura PJ, Bond S, Aschemeier-Fuchs B, Knip M, Tree T, Overbergh L, Pall J, Arnaud O, Haller MJ, Nitsche A, Schulte AM, Mathieu C, Mander A, Dunger D. Wilhelm-Benartzi CS, et al. BMJ Open. 2021 Dec 7;11(12):e053669. doi: 10.1136/bmjopen-2021-053669. BMJ Open. 2021. PMID: 34876434 Free PMC article.
Visualising harms in publications of randomised controlled trials: consensus and recommendations.
Phillips R, Cro S, Wheeler G, Bond S, Morris TP, Creanor S, Hewitt C, Love S, Lopes A, Schlackow I, Gamble C, MacLennan G, Habron C, Gordon AC, Vergis N, Li T, Qureshi R, Everett CC, Holmes J, Kirkham A, Peckitt C, Pirrie S, Ahmed N, Collett L, Cornelius V. Phillips R, et al. BMJ. 2022 May 16;377:e068983. doi: 10.1136/bmj-2021-068983. BMJ. 2022. PMID: 35577357 Free PMC article.
Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial.
Zhao TX, Kostapanos M, Griffiths C, Arbon EL, Hubsch A, Kaloyirou F, Helmy J, Hoole SP, Rudd JHF, Wood G, Burling K, Bond S, Cheriyan J, Mallat Z. Zhao TX, et al. BMJ Open. 2018 Sep 17;8(9):e022452. doi: 10.1136/bmjopen-2018-022452. BMJ Open. 2018. PMID: 30224390 Free PMC article.
127 results