Method - Efficient and effective conduct of clinical trials

方法 - 高效、有效地进行临床试验

• 批准号: MC_UU_00004/08
• 负责人: Matthew Sydes
• 金额: $ 289.24万
• 依托单位: University College London
• 依托单位国家: 英国
• 项目类别: Intramural
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MC_UU_00004%2F08
• 关键词: Method; Efficient; effective; conduct; clinical

Clinical trials help doctors and patients to make better healthcare decisions. The way that a trial is done and the data collected and checked effects the cost of the trial and also directly effects the confidence we can have in its results. Unfortunately, many of the methods that we use to run trials are not based on high quality evidence. We aim to find better and evidenced based ways of running trials more effectively. Trials can also be very expensive, so we are looking at ways we can make them more cost-effective. For example, we want to understand where and how a patients routine medical records can be used to get quicker and cheaper access to data for trials and where this is not possible. Academic organisations often investigate new treatments in diseases which are not a priority for the company that has developed that new treatment. We therefore need better ways in which the results of trials being done by academic organisations can be used by regulatory authorities to improve the speed at which these new treatments can be approved and licensed for use in patients with these diseases.

临床试验帮助医生和患者做出更好的医疗保健决策。试验进行的方式、收集和检查数据的方式会影响试验的成本，也会直接影响我们对试验结果的信心。不幸的是，我们用来进行试验的许多方法并不是基于高质量的证据。我们的目标是找到更好的、基于证据的、更有效地运行试验的方法。试验也可能非常昂贵，所以我们正在寻找使其更具成本效益的方法。例如，我们想了解在哪里以及如何使用患者的常规医疗记录来更快、更便宜地获取试验数据，以及在哪些地方这是不可能的。学术组织经常研究疾病的新疗法，而这些疗法并不是开发这种新疗法的公司优先考虑的。因此，我们需要更好的方法，让学术机构进行的试验结果可以被监管机构使用，以加快这些新疗法被批准和许可用于这些疾病患者的速度。

项目成果

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.

• DOI: 10.1186/s13063-021-05300-x
• 发表时间: 2021-05-24
• 期刊: Trials
• 影响因子: 2.5
• 作者: Bruhn H;Cowan EJ;Campbell MK;Constable L;Cotton S;Entwistle V;Humphreys R;Innes K;Jayacodi S;Knapp P;South A;Gillies K
• 通讯作者: Gillies K

Experiences of running a stratified medicine adaptive platform trial: Challenges and lessons learned from 10 years of the FOCUS4 trial in metastatic colorectal cancer.

• DOI: 10.1177/17407745211069879
• 发表时间: 2022-04
• 期刊: CLINICAL TRIALS
• 影响因子: 2.7
• 作者: Brown, Louise C.;Graham, Janet;Fisher, David;Adams, Richard;Seligmann, Jenny;Seymour, Matthew;Kaplan, Richard;Yates, Emma;Parmar, Mahesh;Richman, Susan D.;Quirke, Philip;Butler, Rachel;Shiu, Kaikeen;Middleton, Gary;Samuel, Leslie;Wilson, Richard H.;Maughan, Timothy S.
• 通讯作者: Maughan, Timothy S.

PROState pathway embedded comparative trial: An update to the IP3-PROSPECT study

PROState 途径嵌入式比较试验：IP3-PROSPECT 研究的更新

• DOI: 10.1016/s0302-2838(22)00413-4
• 发表时间: 2022
• 期刊: European Urology
• 影响因子: 23.4
• 作者: Bass E

PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.

• DOI: 10.1016/j.cct.2021.106485
• 发表时间: 2021-08
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Bass EJ;Klimowska-Nassar N;Sasikaran T;Day E;Fiorentino F;Sydes MR;Winkler M;Arumainayagam N;Khoubehi B;Pope A;Sokhi H;Dudderidge T;Ahmed HU
• 通讯作者: Ahmed HU

Additional consensus recommendations for conducting complex innovative trials of oncology agents: a post-pandemic perspective.

• DOI: 10.1038/s41416-022-02051-7
• 发表时间: 2023-03
• 期刊: BRITISH JOURNAL OF CANCER
• 影响因子: 8.8
• 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.
• 通讯作者: Brown, Louise C.