壹生资讯-开展临床研究的关键不仅在于药物，更在于严谨的执行

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开展临床研究的关键不仅在于药物，更在于严谨的执行 | 立足国内，面向世界

2025-05-20作者：CMT琳资讯

原创

2025年4月19日，第三届泌尿肿瘤临床研究大会在北京正式召开。本次大会秉承传统，以主旨报告、中国泌尿肿瘤临床研究的现状、ADC药物的临床与探索、核素药物的腾飞、临床研究精读、细胞治疗篇、围手术期临床研究篇七个环节，聚焦泌尿肿瘤临床研究热点，集结泌尿内、外科医生和申办企业三方，对临床研究和诊疗实践的难点、困境及新方向、新思想进行了交流探讨。

伦敦玛丽女王大学巴茨癌症研究所Thomas Powles教授作为特邀嘉宾参会，并在“立足国内，面向世界”讨论环节，回答了与会学者的踊跃提问。中国医学论坛报今日肿瘤将该环节的5个问答整理成辑，为大家呈现一场中国专家和国际视野的交互碰撞。

刘卓炜教授

中山大学肿瘤防治中心

作为EV-302研究的全球leading PI，你认为完成这项研究的过程中最困难的事情是什么？

So as the global leading PI, what's the most difficult thing for you to fulfill the EV-302 ?

Prof. Thomas Powels

伦敦玛丽女王大学巴茨癌症研究所

这个问题很难问答。过去40年内，我们一直在探索比铂类化疗更好的治疗药物。坦率地讲，最核心的问题有两点。首先，过去我们没有足够好的药物，但是现在情况不同，我们已经有了更好的药物。第二点，在过去很长时间内，我们并没有开展高水平的临床研究。我们在小规模Ⅱ期临床试验上花费了大量时间。虽然取得了不错的结果，但直到我们真正团结起来形成协作，才开始取得真正的进展。实际上，NIAGARA试验是个很好的例子。在我职业生涯的早期，我参加过类似的会议，可能规模更小些，气氛可能也没这么融洽。当时我们讨论要做肌层浸润性膀胱癌的临床试验，但从未招募到超过400例患者。我们总是无法达到Ⅲ期试验所需的入组量。NIAGARA试验之所以能得出阳性结果，其中一个原因……我必须强调，并不只是因为度伐利尤单抗多么特别——它确实是款好药，确实有效，但这并不是试验成功的唯一原因。试验获得阳性结果的真正原因在于纳入了1000多例患者，试验执行严谨，而且是国际多中心协作的成果。所以这再次证明，开展临床研究的关键不只在于拥有好药，更在于严谨的执行。

That's a very difficult question. But we spend forty years trying to beat platinum-based chemotherapy. The biggest problem, speaking frankly, two things. Number one is we didn't have enough good drugs. We do have that now, better drugs. And number two，We didn't do great trials speaking frankly. So we spend a lot of time doing small phase Ⅱ trials with some drugs. Sure, quite good. But it wasn't until we got together as a group that we started to really move forward. And actually, the NIAGARA trial is the example of that, because it's a better example. Let me tell you the NIAGARA story, at the beginning of my career, I went into rooms similar to this, maybe a bit smaller, maybe started less friendly. And we would talk about doing muscle invasive bladder cancer trials, but we never recruited more than 400 patients. We always failed to recruit enough patients to do a phase Ⅲ. One of the reasons why NIAGARA is positive. It is not because durvalumab is a right drug. It's a good drug here. It does work. But that's not the reason it's positive. The reason it's positive is that but also is a thousand patients. It's well conducted and it's an international collaboration. So it's not just all about good drugs. It's also about good execution.

整理 | 中国医学论坛报黄琳琳

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