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Adaptive designs in clinical trials: why use them, and how to run and report them.
Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, Holmes J, Mander AP, Odondi L, Sydes MR, Villar SS, Wason JMS, Weir CJ, Wheeler GM, Yap C, Jaki T. Pallmann P, et al. Among authors: holmes j. BMC Med. 2018 Feb 28;16(1):29. doi: 10.1186/s12916-018-1017-7. BMC Med. 2018. PMID: 29490655 Free PMC article.
Practicalities in running early-phase trials using the time-to-event continual reassessment method (TiTE-CRM) for interventions with long toxicity periods using two radiotherapy oncology trials as examples.
van Werkhoven E, Hinsley S, Frangou E, Holmes J, de Haan R, Hawkins M, Brown S, Love SB. van Werkhoven E, et al. Among authors: holmes j. BMC Med Res Methodol. 2020 Jun 22;20(1):162. doi: 10.1186/s12874-020-01012-z. BMC Med Res Methodol. 2020. PMID: 32571298 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. Among authors: holmes j. BMJ. 2022 May 16;377:e068983. doi: 10.1136/bmj-2021-068983. BMJ. 2022. PMID: 35577357 Free PMC article.
A Bayesian phase 2 model based adaptive design to optimise antivenom dosing: Application to a dose-finding trial for a novel Russell's viper antivenom in Myanmar.
Watson JA, Lamb T, Holmes J, Warrell DA, Thwin KT, Aung ZL, Oo MZ, Nwe MT, Smithuis F, Ashley EA. Watson JA, et al. Among authors: holmes j. PLoS Negl Trop Dis. 2020 Nov 16;14(11):e0008109. doi: 10.1371/journal.pntd.0008109. eCollection 2020 Nov. PLoS Negl Trop Dis. 2020. PMID: 33196672 Free PMC article.
A phase II open label, randomised study of ipilimumab with temozolomide versus temozolomide alone after surgery and chemoradiotherapy in patients with recently diagnosed glioblastoma: the Ipi-Glio trial protocol.
Brown NF, Ng SM, Brooks C, Coutts T, Holmes J, Roberts C, Elhussein L, Hoskin P, Maughan T, Blagden S, Mulholland P. Brown NF, et al. Among authors: holmes j. BMC Cancer. 2020 Mar 12;20(1):198. doi: 10.1186/s12885-020-6624-y. BMC Cancer. 2020. PMID: 32164579 Free PMC article. Clinical Trial.
A phase 1 trial of the safety, tolerability and biological effects of intravenous Enadenotucirev, a novel oncolytic virus, in combination with chemoradiotherapy in locally advanced rectal cancer (CEDAR).
O'Cathail SM, Davis S, Holmes J, Brown R, Fisher K, Seymour L, Adams R, Good J, Sebag-Montefiore D, Maughan T, Hawkins MA. O'Cathail SM, et al. Among authors: holmes j. Radiat Oncol. 2020 Jun 12;15(1):151. doi: 10.1186/s13014-020-01593-5. Radiat Oncol. 2020. PMID: 32532291 Free PMC article. Clinical Trial.
3,107 results