Additional consensus recommendations for conducting complex innovative trials of oncology agents: a post-pandemic perspective.
Additional consensus recommendations for conducting complex innovative trials of oncology agents: a post-pandemic perspective.
复制标题
DOI：
10.1038/s41416-022-02051-7
复制
发表时间：
2023-03
影响因子：
8.8
通讯作者：
Brown, Louise C.
中科院分区：
文献类型：
--
作者：
Blagden, Sarah P.;Yu, Ly-Mee;Ellis, Stephanie;Hughes, Helen;Shaaban, Abeer;Fennelly-Barnwell, Jonathan;Lythgoe, Mark P.;Cooper, Alison M.;Maignen, Francois M.;Buckland, Sean W.;Kearns, Pamela R.;Brown, Louise C.
在我们2020年的共识论文中，我们为开展复杂创新设计（CID）试验来评估癌症药物提出了10项建议。在报告发表后的几周内，英国就遭受了第一波SARS-CoV-2大流行的袭击。大型CID试验被优先考虑，以比较新的和重新利用的COVID-19治疗方法的疗效，并为监管决策提供信息。大流行的不寻常情况意味着，“康复”等研究几乎立即开始，并招募了创纪录数量的参与者。但是，试验小组必须对这些研究作出让步和调整，以确保迅速和广泛地进行招募。由于这些与招收具有相似风险因素的患者的癌症试验相关，我们在原来的十条建议基础上增加了三条新建议：采用实用主义，例如使用重点信息表和只收集最相关的数据；采用无纸化系统，尽量减少对环境的负面影响；并使用直接与患者沟通的方法来提高接受度。这些建议可应用于所有肿瘤学CID试验，以提高其包容性、吸收性和效率。最重要的是，在COVID-19大流行期间，CID研究的成功强调了它们作为快速治疗评估工具的有效性。
In our 2020 consensus paper, we devised ten recommendations for conducting Complex Innovative Design (CID) trials to evaluate cancer drugs. Within weeks of its publication, the UK was hit by the first wave of the SARS-CoV-2 pandemic. Large CID trials were prioritised to compare the efficacy of new and repurposed COVID-19 treatments and inform regulatory decisions. The unusual circumstances of the pandemic meant studies such as RECOVERY were opened almost immediately and recruited record numbers of participants. However, trial teams were required to make concessions and adaptations to these studies to ensure recruitment was rapid and broad. As these are relevant to cancer trials that enrol patients with similar risk factors, we have added three new recommendations to our original ten: employing pragmatism such as using focused information sheets and collection of only the most relevant data; minimising negative environmental impacts with paperless systems; and using direct-to-patient communication methods to improve uptake. These recommendations can be applied to all oncology CID trials to improve their inclusivity, uptake and efficiency. Above all, the success of CID studies during the COVID-19 pandemic underscores their efficacy as tools for rapid treatment evaluation.
登录
查看更多内容
DOI：
10.1056/nejmoa2022926
发表时间：
2020-11-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
RECOVERY Collaborative Group;Horby P;Mafham M;Linsell L;Bell JL;Staplin N;Emberson JR;Wiselka M;Ustianowski A;Elmahi E;Prudon B;Whitehouse T;Felton T;Williams J;Faccenda J;Underwood J;Baillie JK;Chappell LC;Faust SN;Jaki T;Jeffery K;Lim WS;Montgomery A;Rowan K;Tarning J;Watson JA;White NJ;Juszczak E;Haynes R;Landray MJ
通讯作者：
Landray MJ
影响因子：
51.1
作者：
Kendall, Timothy J.;Robinson, Max;Harrison, David J.
通讯作者：
Harrison, David J.
DOI：
10.1016/s2213-2600(21)00460-4
发表时间：
2022-03
期刊：
The Lancet. Respiratory medicine
影响因子：
--
作者：
Fisher BA;Veenith T;Slade D;Gaskell C;Rowland M;Whitehouse T;Scriven J;Parekh D;Balasubramaniam MS;Cooke G;Morley N;Gabriel Z;Wise MP;Porter J;McShane H;Ho LP;Newsome PN;Rowe A;Sharpe R;Thickett DR;Bion J;Gates S;Richards D;Kearns P;CATALYST investigators
通讯作者：
CATALYST investigators
DOI：
10.1158/1078-0432.ccr-20-3421
发表时间：
2021-01-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Newman LA;Winn RA;Carethers JM
通讯作者：
Carethers JM
影响因子：
2.9
作者：
Hayward G;Butler CC;Yu LM;Saville BR;Berry N;Dorward J;Gbinigie O;van Hecke O;Ogburn E;Swayze H;Bongard E;Allen J;Tonner S;Rutter H;Tonkin-Crine S;Borek A;Judge D;Grabey J;de Lusignan S;Thomas NPB;Evans PH;Andersson MI;Llewelyn M;Patel M;Hopkins S;Hobbs FDR
通讯作者：
Hobbs FDR