临床试验预算编制的最佳实践

优秀的临床研究专业人士不是天生的，而是后天培养的。

Great clinical research professionals aren't born, they're built.

在每一集中，您都将听到临床试验管理领域的顶尖专家分享他们的见解，激励您成为一位高效的领导者。

In each episode, hear from leading experts in clinical trial management as they inspire and motivate you to become an effective leader.

欢迎收听《临床试验播客》。

Welcome to the Clinical Trial Podcast.

帮助您加速职业发展的主持人是库纳尔·萨马特。

Here to help you accelerate your career is your host, Kunal Sampath.

大家好。

Hi friends.

欢迎来到《临床试验播客》的又一集。

Welcome to another episode of the Clinical Trial Podcast.

我是您的主持人库纳尔·萨马特，我的工作是帮助您加速临床研究职业生涯。

I'm your host, Kunal Sampath, where my job is to help you accelerate your clinical research career.

这是本播客在Research Revolution大会上的现场录制特别集，该大会由Florence Healthcare主办。

This is a special episode of the podcast recorded live at Research Revolution, a clinical research conference hosted by Florence Healthcare.

在这一集中，我们将探讨临床研究中最大且最持久的瓶颈之一——临床试验预算编制。

In this episode, we're tackling one of the biggest and most persistent bottlenecks in clinical research, clinical trial budgeting.

预算谈判是研究启动阶段延迟的主要原因。

Budget negotiations are a major source of delay during study startup.

尽管赞助方、CRO和研究机构都有多年的经验，但同样的问题依然不断出现。

And despite years of experience across sponsors, CROs and sites, the same problems continue to surface.

响应缓慢、理由不明确、期望不一致以及沟通断裂。

Slow response times, unclear justifications, misaligned expectations and breakdown in communication.

那么，究竟是什么导致预算谈判陷入停滞？

So, what actually causes budget negotiations to stall?

研究机构如何提供清晰、有依据且高效的预算说明？

How can sites provide justification that are clear, defensible and efficient?

赞助方究竟需要什么才能批准超出预期的项目条目？

What do sponsors really need in order to approve higher than expected line items?

双方如何建立更多的信任与透明度，以减少无休止的来回拉扯？

And how can both sides build more trust and transparency to reduce endless back and forth?

为了解答这些问题，我邀请了三位领导者，他们从截然不同但高度互补的角度看待这一过程。

To unpack these questions, I was joined by three leaders who see this process from a very different but highly complementary angles.

首先是辉瑞公司高级经理兼研究协议负责人克里斯汀·麦肯娜。

First, Kristin McKenna, senior manager and investigator contracts lead at Pfizer.

克里斯汀负责全球大型临床项目中的研究中心预算和合同事务，对推动审批、提高效率和降低风险有着深刻的申办方视角。

Kristin oversees global site budgeting and contracting across large scale clinical programs and brings deep sponsor side insight into what drives approvals, efficiency, and risk mitigation.

接下来是海蒂·卡斯尔，一位拥有十余年经验的临床研究专业人士，涵盖研究中心运营、计费合规和预算谈判等领域。

Next, Heidi Castle, a clinical research professional with over a decade of experience spanning site operations, billing compliance, and budget negotiations.

目前担任梅西研究公司业务发展总监的海蒂，带来了立足于实际运营限制的务实研究中心视角。

Currently director of business development at Mercy Research, Heidi brings a practical site centered perspective grounded in real operational constraints.

最后是路径集团的首席执行官兼首席顾问马特·洛里。

And finally, Matt Lohrey, CEO and principal consultant at the Pathways Group.

马特在研究中心和申办方角色方面拥有十八年以上的经验，直接为研究机构提供预算谈判、财务审计和运营可持续性方面的支持，并敢于挑战当前系统的运作方式。

With more than eighteen years of experience across site and sponsor roles, Matt works directly with research sites on budget negotiations, financial audits, and operational sustainability, and isn't afraid to challenge how the system works today.

这三位嘉宾共同带来了一场坦诚、基于经验的对话，探讨临床试验预算编制中哪些环节存在问题、哪些正在改善，以及为了实现更快、更可持续的研究启动，我们还需要做出哪些改变。

Together, this panel delivers a candid experience driven conversation on what's broken in the clinical trial budgeting, what's improving, what needs to change if we want faster, more sustainable study startup.

如果你参与过预算编制、合同签订或研究启动的任何环节，这一集你一定要仔细聆听。

If you're involved in budgeting, contracting, or study startup in any capacity, this is an episode you'll want to listen closely.

现在我们开始吧。

Now let's get into it.

好的，欢迎回到埃林顿，今天我们最后一场分组讨论。

All right, welcome back to Ellington to our final breakout session of the day.

本环节将分享来自行业工作组的调研成果，该工作组致力于改善临床试验预算编制。

This session will share findings from across industry working group focused on improving clinical trial budgeting.

我们的小组成员库纳尔、马特、克里斯汀和海迪，分别代表研究机构、申办方和CRO，他们识别了研究财务领域的关键挑战，并制定了切实可行的策略，以促进协作、简化流程并增进相互理解。

Our panelists, Kunal, Matt, Kristen and Heidi, represent site sponsor CROs, who have identified key challenges in research finance, and developed practical strategies to enhance collaboration, streamline workflows, and build mutual understanding.

这还是一场特别的环节，因为这是一场现场直播的播客录制。

This is also a special session because it's also a live podcast recording.

接下来，我将把时间交给库纳尔，由他来开启本次讨论。

So, I'll turn it over to Kunal to kick us off.

谢谢。

Thank you.

很好。

Great.

非常感谢你的介绍。

Thank you so much for the introduction.

是的，我非常兴奋能有这个机会，与这些杰出的嘉宾们进行一场深入的对话，他们都是很棒又有趣的人，特意抽出时间来到这里，共同探讨临床试验预算编制的最佳实践。

Yeah, I'm really excited to have this opportunity with these esteemed panelists who are wonderful, fun people who have taken time away from their to be here to have a really rich conversation about best practices for clinical trial budgeting.

我们将在最后留出时间回答观众的问题，但现在就让我们开始吧。

We will allow for audience questions towards the end, but we will get started right now.

临床试验预算编制一直是研究启动中的长期瓶颈。

So, clinical trial budgeting has been a long standing bottleneck in study startups.

从你们的角度来看，赞助方和研究机构在预算谈判中，最常见的导致延误的痛点是什么？

From your perspective, what are the most common pain points that cause delays during budget negotiations between sponsors and sites?

我先请海蒂发言，然后马特和克莉丝汀再补充。

I'll start with Heidi and then Matt and Kristen can close it up.

好的。

Yep.

谢谢库纳尔。

Thanks Kunal.

我认为我遇到的首要大问题是申办方或CRO方缺乏回应。

I would say the the first major issue that I run into is non responsiveness from the sponsor CRO end of things.

没有什么比花几个小时制定好预算后发出去却石沉大海更让人沮丧的了。

Nothing is worse than when you spend hours developing a budget and send it out, and it's just crickets.

所以，这绝对是我在工作中经常遇到的问题——整体响应速度太慢。

So that's definitely what I you know, I just think responsiveness overall is definitely an issue that that I encounter.

但我也想补充一点，这不完全是流程问题，而是心态问题。

But I also wanted to add too, not necessarily related to process, but also mindset.

今天早上的主旨演讲中也提到了这一点，那就是要摒弃研究机构、申办方和CRO之间的‘我们对你们’的对立心态。

And it was mentioned earlier this morning during the keynote, but getting rid of The Us versus them mindset with regards to site sponsors and CROs.

而且，从一开始就进行对话，让我们从一个平等的起点开始。

And, you know, upfront having that that dialogue that, you know, we're let's start from a level playing field.

我们的目标是一致的，那就是为患者提供突破性的治疗，或他们原本无法获得的治疗。

We have the same goal in mind, is providing patients with groundbreaking treatment or treatment they may not have received otherwise.

所以我认为，打下这样的基础确实有助于缓解沟通方面的些许瓶颈，以及那种你有时感受到的拉扯感。

So I think laying that foundation definitely helps with a little bit of that bottle neck with regards to communication and that that pull that you feel sometimes.

对我来说，我花了大量时间打电话给赞助方辩护预算，我注意到的一个导致很多问题的现象是，从研究站点这边，我们会把某件事称为某种名称。

So for me, I spent a lot of time on the phone with sponsors defending budgets, and one of the things that I have seen that has created a lot of problems is coming from the site side, we'll call it one thing.

但与赞助方沟通时，他们却用另一个名字来称呼同一件事。

Talking to the sponsors, they're calling it something else.

当你和赞助方通电话，逐个讨论痛点，试图弄清楚‘我能给他们什么？我能告诉他们什么？’时，情况就会变得复杂。

But then you're on the phone with the sponsor and you're going through all of the pain points, you're trying to figure out, okay, you know, what can I give them, what can I tell them?

于是我会详细描述一个关于他们某项事物的问题，而他们会说：‘哦，你说的是X Y Z啊。’

And so I'll go into this lengthy description of a question about something that they have, and they'll say, oh, you're referring to x y z.

在我们这边，我们只是用另一个名字来称呼它。

We just call it something else on this side.

但我说，只要你们批准了，你们想在预算里怎么称呼都行。

And I'm like, well, I'm fine with whatever you want to call it in the budget as long as you approve it.

我代表赞助方。

I'm representing Sponsor.

讽刺的是，我们在站点响应迟缓、资源不足、无法与不在办公室的人或发生事故时进行谈判方面也面临类似问题，因为每个站点只有一个人能进行谈判。

We ironically have similar issues with sites being unresponsive, resourcing issues at sites, not being able to negotiate if someone is out of the office, or if there's an accident, there's only one person at the site who can negotiate.

而且如果能提前获取所有信息，比如在增加费用时提前提供理由或文件，就能大大减轻我们这边的负担。

And then getting all of the information upfront, so if you add a fee in, providing justification or documentation for that upfront, alleviates a lot of the pain points on our end.

是的，这正好引出了我们下一个问题。

Yeah, that's a great segue into our next question.

因此，在我们准备会议中提到的一个主题就是预算理由文件。

So, of the themes that came up during our prep meetings was the having a budget justification document.

那么，站点该如何提供清晰高效的理由，又不会让赞助方信息过载呢？

So, how can sites provide justifications that are clear and efficient without overloading sponsors with information?

那么，我们先请克里斯汀谈谈这个观点。

So, maybe we'll start with Kristen first on that.

好的。

Yeah.

所以，我们希望看到的是，你知道的，这个具体是什么。

So, we we wanna see, you know, what this is.

有时候站点会使用缩写，我不知道这些缩写是什么意思。

Sometimes sites have acronyms, I don't know what that acronym means.

所以如果你能解释一下原因、内容和用途，比如这个费用需要额外增加工时，就给我一个大致的估算。

So if you have an explanation of that, the why, the what, the where, if it's a fee that requires additional hours, give me that approximation.

这项工作会花费研究协调员四个小时。

This takes the study coordinator four hours.

因为这样我就可以查看我们的系统，然后确认这个成本如何合理。

Because then I can look into our systems and then, okay, this is how we can justify this cost.

关键是把每一项具体拆解清楚，说明这到底是什么。

And just really that breaking it down, what exactly this is.

如果你只给我一份价目表，这并不能告诉我这个费用的具体用途。

If you give me a price list, that's not telling me what that fee is.

如果我无法向审计人员解释这个费用，那就不好了。

And if I can't explain that fee to an auditor, that's no good.

所以，这其实涉及到合规性问题。

So, it's kind of a compliance.

如果我能解释清楚这个费用，并且理解它，我们就能找到一个变通办法。

If I can explain that fee, okay, and I can understand it, we can find that workaround.

所以，我总是被问：我提供的信息是不是太多了？

So, I'm always called, do I give too much information?

我是不是提供的细节不够，导致他们回头来找我说：嘿，我们需要更多细节。

Do I not give enough detail and then let them come back from to me and say, hey, We need a little bit more detail.

我们不太清楚你到底在说什么。

We're not exactly sure what you're talking about.

所以这些年来，因为我一直担心会出现瓶颈。

So kind of over the years because I'd I'm always concerned about bottlenecks.

我不希望成为拖慢流程的那部分。

And I'm like, I I don't want to be the part that is slowing the process down.

这些年来，我在为各站点撰写理由说明时，通常会说：好吧，为了谨慎起见，我们多给一点信息。

What I have done over the years developing justifications with sites is I will say, okay, well, let's on the side of caution and give them a little bit too much information.

这样，如果他们之后还需要更多信息，他们自然会再问。

In that way, if they need more information later on, then they can ask for it.

但我不想一开始就提供不足的信息，然后引发另一轮邮件和电话往来。

But I don't want to start by not giving them enough and then causing another round of emails and another round of calls and all that.

但很多情况也回到站点本身。

But a lot of that also comes back to the site.

因为当我与站点合作并整理他们的文档时，你必须能告诉我 x y z 需要哪些内容，这样我才能把这些转化为你的理由说明；而当这些材料提交给资助方时，他们就能清楚地理解你们真正所要求的是什么。

Because when I'm working with a site and I'm putting together their documentation, like, you've got to be able to tell me what goes into x y z because that way I can transfer that into what goes on your justification, but then when it gets to the sponsor side, then that gives them a really solid understanding of what you're actually asking for.

如果你作为一个站点都不了解自己的工作流程和流程，那你怎么能把这些信息传达给资助方呢？

So if you're a site and you don't understand your own workflows and processes, then how are you gonna get that information to the sponsor?

对。

Right.

是的，海蒂，你请说。

Yeah, go for it, Heidi.

我从站点的角度补充一点，这和马特说的有点类似，但我总是过度解释。

I'll add from the site side, and I kinda parallel to what Matt said, but I over justify.

我确实有这个问题。

I'm definitely guilty of that.

我们有一份管理费费率表，我会在所有预算谈判中随附发送。

We have a administration fee schedule that I send out with all budget negotiations.

这份费率表涵盖了从启动到结题的所有费用，包括药房费用、监查费用等等。

This covers everything from start up to close out, pharmacy fees, monitoring fees, you name it.

在各项费用下方，都有相应的理由说明。

Under the cost, there is justification for such.

因此，这份费率表会随我标注修改的初始预算一并提供。

So that is delivered with the initial budget when I red line it for negotiations.

我还会在预算中逐项标注所有费用，使其与管理费费率表完全一致，因为我知道有些申办方或CRO根本不会阅读那份文件。

I also do red line all of the fees in the budget to match the admin fee schedule, because I also am aware that some sponsors or CROs, they won't even read it.

他们只会直接跳到预算部分。

This large document, they'll just go right to the budget.

所以这确实需要一些策略，但拥有一个理由说明文档非常重要，我们的文档是使用信头纸打印的。

So it's definitely there's strategies to it, but having having a justification document, ours is on letterhead.

并且已经签字。

It's signed.

我们还将间接费用单独列在信纸上，并附上理由说明。

We also have our overhead on separate letterhead with justification there.

这确实有助于推动谈判进程。

Definitely helps get the ball rolling with regards to negotiations.

我希望这能减少来回沟通，但时间会证明这一点。

And I would like to think it cuts down on the back and forth, but time tells on that one.

是的。

Yeah.

还有一件事，如果你是研究站点，并且你真的坐下来梳理你的工作流程，因为你正在准备理由说明，很多时候，当我与站点这样做时，这会成为一个让他们发现自身问题或改进方式的练习。

And and one one other thing is if you if you're a site and you do go through this process of where you're sitting down and you're going through what your workflows look like because you are preparing your justification, a lot of times when I'm doing that with sites, that ends up becoming an exercise and them learning what's not working for them or ways that they could be doing things better.

但同时，他们也会发现一些他们没有在预算中申请的项目。

But then they'll also identify things that they're not requesting in their budget.

所以我会说，哦，我们还需要在你的费用表中加入一些内容，也要在你的理由文件中补充一些东西。

So I'm like, oh, there's something else that we need to put in your fee schedule, and there's something else that we need to put into your justification document.

当然。

Sure.

所以，关于可行性说明文件，我们团队——实际上是海蒂——整理了一份示例文件，我们会在最后与大家分享。

So, talking about the justification document, the team here put together, actually Heidi put together a sample justification document, so we'll share this with everybody towards the end.

屏幕上会出现一个二维码，你们可以扫描后访问网站获取这些信息。

There'll be a QR code that'll pop up and you can go to the website to get that information.

许多机构在谈判开始前，很难理顺内部事务。

Many sites struggle to get their internal house in order before negotiations start.

在创建内部模板、收费清单或费率表方面，你们见过哪些最佳实践，能让这个过程更顺畅？

What best practices have you seen around creating internal templates, charge masters or rate cards that can make the process much smoother.

所以，马特，你来谈谈这个好吗？

So Matt, maybe you wanna take that?

我很乐意来谈谈这个。

I would love to take that.

所以，由于我经常与各机构合作，你必须清楚你们机构内部的实际情况。

So again, working with sites a lot, you have to know what is going on at your site.

你必须能够把这些内容写下来，了解你们的工作流程和操作流程等等。

And you have to be able to write that down and know what your workflows and your processes are, etcetera, etcetera, etcetera.

但对我来说，你应该有一个流程。

But for me, you should have a process.

你应该有一个标准化的流程，来处理所有事情——尤其是预算方面，你必须清楚这个流程，并且每次与每个赞助商打交道时都必须严格执行。

You should have a standardized process of how you do, for me, I like to say how you do everything, but especially when it comes to your budgets, you have to know what that process is and you need to follow that process every time, every budget with every sponsor.

不仅要了解流程，还要清楚你使用的文件，比如你的费用表、理由模板或间接成本政策。

And not just the process, but also the documents that you use, whether it's your fee schedule, whether it's your justification template, whether it's your overhead policy.

清楚你的流程，了解你的成本，然后每次都严格遵循。

Know what your process is, know what your costs are, and then follow that each and every time.

因为对我来说，公平和透明是确保你对每个赞助商都做到公平透明的绝佳方式。

Because for me, being fair and transparent, that's a very good way of making sure that you're being fair and transparent with every sponsor.

非常好。

Love it.

我还要补充一点，从站点的角度来看，我们在所有启动研究中都会内部召开一次覆盖分析和预算审查会议。

I'll also add on that from the site side, something that we do for all of our studies in startup, is we have a coverage analysis and budget review call as a team internally.

参会人员包括我、我们的启动协调员以及临床团队。

It's myself, our startup coordinator, and the clinical team.

在这次会议上，主要目的是审查覆盖分析中的计费分类，解答任何问题，然后我会展示我制定的内部预算，可能需要大家对时间和工作量项目提供反馈，或者确认某些问卷或其他信息是由研究者还是协调员负责。

So, on that call is really the point of it is to review our billing designations on the coverage analysis, answer any questions, and then I also present the internal budget that I have developed, and maybe I need feedback on time and effort items, maybe I need to know if there's certain questionnaires, or other bits of information, whether or not the PI is responsible for this or the coordinator.

这也有助于在进入谈判前统一各方的理解。

So that also helps level set everything before going into negotiations.

但我同意马特的说法，为所有研究建立并遵循一套流程，甚至将这些流程写入标准操作程序（SOP）中，确实非常有帮助。

But I agree with what Matt said, having a process and following that for all of your studies, and even laying that out within SOPs definitely helps as well.

你问题的第二部分，库纳尔，是关于费率表的。

The second piece of your question, Kunal, regarding rate cards.

我们确实与许多赞助商签订了预算费率表、主CTA和CDA协议。

We do have budget rate cards, master CTAs, CDAs, with a bunch of sponsors.

我给的最好建议是，提前跟进这些协议的续签工作。

And I will say my best advice there is to keep ahead of those, in those renewals.

我们用一个追踪表来管理这些协议。

We have ours on a tracker.

最好有一两个人专门负责监控，并与相关联系人保持沟通，确保协议的日期不会过期。

It's nice if you have one or two people monitoring that, and staying connected with those contacts to make sure that the dates on them don't lapse.

我简单说一下，因为我们现在在佛罗伦萨的站点支持小组，这次会议中我们的一项工作是创建了一份预算依据指导文件。

I just real quick, wanted, because we're on the site enablement league here at Florence, and one of the things we worked on in this session was creating a budget justification guidance document.

所以，如果你以前从未做过这类事情，可以使用佛罗伦萨团队现在协助创建的这些文档。

So, if this is something you've never done before, you know, utilize the documents that Florence has now helped create.

是的，完全同意。

Yeah, absolutely.

我想附和克里斯滕的说法。

I would like to echo what Kristen said.

所以，到会议结束时，你们可以下载这个小组创建的三份文件，以及海蒂整理的那份文件。

So, when we get to the end, you'll be able to download all those three documents that this group created, and then the one that Heidi put together.

好的。

Sure.

另外还有一个想法：如果你确实有流程，并且使用了你们自己整理的文档，这会让我更容易向赞助方说明你们的请求，因为你不是凭空提出的。

And then one additional thought is if you do have a process, if you are using the documents that you put together, for me that makes it much easier to justify to sponsors what you're requesting because you're not pulling it out of the air.

这些请求都是基于现实的。

It's based in reality.

对。

Right.

所以，我听到你们说的是，我们一开始在谈‘我们’和‘他们’，然后就开始建立相关流程。

So what I'm hearing you guys say, know, we started talking about us versus them, and then we started having a process around things.

所以，综合来看，我想问问大家，站点和申办方如何能在预算编制过程中建立更多的信任与透明度，以减少来回谈判的次数？

So just kind of put it all together, I want to ask you guys about how can sites and sponsors build more trust and transparency into the budgeting process to reduce the back and forth negotiation cycle?

那我想先请克里斯蒂安谈谈这个观点。

So I'd like to maybe start with Kristian on that.

关键在于沟通。

I mean, the big thing is communication.

就像我们之前讨论的，要提前提供相关文档。

Like we've discussed, having that documentation to provide initially.

我也非常建议进行电话沟通。

I also really encourage having phone calls.

如果你在看一个申办方的模板，而每个申办方的模板都不同，让你感到困惑，或者不知道该在哪里填写你的费用，那就直接给对方的谈判人员打个简短电话，说：‘我不太清楚，你能帮我解释一下吗？’或者‘我有这个费用，但不确定该怎么填进去’，请他们帮你理清思路。

If you're looking at a sponsor template, and every sponsor has their own separate template and it's confusing to you or you don't know where to plug in your fee, do a quick call with your negotiator on the other side and say, I don't, you know, explain to me here or I have this fee, I'm not sure how this fits in, and have them help walk you through it.

这样你的费用就能得到保障，而不会出现额外的一轮沟通，说‘我把它放在这里了，但其实应该放在那里’。

So that your fee still gets covered and you're not doing an extra round saying, well I added it here, but it should have been there.

你知道，沟通真的非常重要。

You know, communication is a really big thing.

完全正确。

Absolutely.

我喜欢在沟通之后再跟进一次，因为无论是和赞助方还是CRO谈预算，我都不是他们唯一合作的中心，也不是他们唯一处理的预算。

And I like following up communication with a communication, because whether I'm working with a sponsor or a CRO on a budget, you know, I'm not the only site that they're working with, I'm not the only budget that they're working with.

所以，如果我打电话给预算合同负责人并进行了交流，我总是喜欢在之后发一封总结邮件。

So if I call the budgetcontract person and we have a conversation, I always like to follow that conversation up with a summary email.

因为这不仅提醒我曾经和他们沟通过，也让我和他们明确我们讨论的内容。

Well, because not only does that remind me that I talked to them, but it also tells me and them what we talked about.

所以，如果我们达成了任何共识，哪怕只是像我何时提交第一版修改意见这样微小的日期，我也会有书面记录。

So if we agreed on anything, if we even if it's something as trivial as a date where I'm gonna have first revisions to them, I've got that in writing.

而且，是的，有时这确实被用来针对我，但只要不是通过邮件进行的沟通，我都会跟进一份书面记录，以确保所有内容都有可追溯的审计轨迹。

And, yes, sometimes that has been used against me, but I I just anytime there's a communication that is that is not an email, I like following up with something so there's an audit trail for everything.

我非常喜欢。

I love it.

我再补充一点，关于建立信任和透明度。

And I'll just add for building trust and transparency.

当我想到合理化时，我常常会想到管理费和你的管理费收费标准。

When I think of justification, my mind often goes to administration fees and your administration fee schedule.

然而，当考虑到每位患者的预算，以及你如何打包CPT代码或时间和工作量项目时，我总是尽量保持透明。

However, when thinking about the per patient budget as well, and how you are maybe bundling CPT codes, or time and effort items, I always try to be as transparent as I can.

我会提供小时费率，让赞助方知道，比如我们的知情同意书（ICF）之所以这么贵，是因为我们的研究者、协调员和护士的小时费率是多少，以及我们平均分配的时间是多少。

I give hourly rates, I let the sponsor know, maybe our ICF is this expensive, because this is how long, or this is the hourly rate our PI is at, that our coordinator and nurses are at, this is the time that we have averaged and allocated item.

然后，就像克莉丝汀那边说的，向赞助方提问是可以的。

Towards And then sometimes too, like going to Kristen's side, it's okay to ask the sponsor questions.

如果我看到一个肿瘤活检费用超过9000美元，我会假设这个价格里包含了大量其他项目。

If I see a tumor biopsy for over $9,000 I'm assuming that there are a lot of things bundled into that price.

麻醉、可能还有本地实验室检测、病理分析，等等。

Anesthesia, maybe there's local labs, pathology, you name it.

因此，在制定每位患者的预算时，提前明确这些细节可以避免大量来回沟通。

So understanding as well when you're pricing out the per patient budget, and getting that clarification ahead of time will save a lot of back and forth.

是的，我来补充一点。

Yeah, and I'll add to that.

我时不时会和申办方或CRO交谈，发现我们的报价差距巨大，我这边和对方那边完全不在一个频道上，搞不清楚为什么数字差异这么大。

Every so often, I'll be talking with a sponsor, CRO, and our numbers are just, I'm on one end of the spectrum and they're on the other end of the spectrum, and we cannot figure out why are our numbers so different.

于是我会问：你们的报价是怎么算出来的？能分享一下细节吗？

Well, I'll say, you know, what went into figuring your number, is there anything you can share?

你们能提供具体的CPT编码吗？这样我就能清楚你们具体在要求什么，因为我知道，如果我回到研究中心说，好吧，这是某项评估或某项操作。

Are there CPT codes that you can share that lets me know exactly what you're requesting because I know, like if I go back to the site and I say, okay, well, it's this assessment or this procedure.

他们可能会问我：这取决于患者人群、治疗领域或适应症，可能是这个，也可能是那个，或者另一个，或者再一个。

Well, they might ask me, well, depending on the patient population or depending on the therapeutic area or depending on the indication, it might be this or it might be this or it might be this or it might be this.

你知道的，可能有九种不同的情况。

You know, it could be nine different things.

是的，这是一项评估、一项操作，但可能有九种不同的执行方式。

It's yeah, it's one assessment, it's one procedure, but it could be done nine different ways.

我们包括了什么？

What are we including?

那么我会回去问赞助方和CRO：我们到底在做什么？

Well then I'll go back to the sponsor and the CRO and I'll say, what exactly are we doing?

你们能提供给我一个或多个CPT代码吗？这样就能明确告诉研究站点协议中要求的具体内容。

Is there a CPT code or codes that you can share with me that tells the site exactly what is being requested of them in the protocol?

有些赞助方和CRO会很乐意提供这些信息。

And some sponsors will readily give that information oh, sponsor CROs.

有些赞助方和CRO会很乐意提供这些信息，但其他人却说他们不能分享。

Some sponsor CROs will readily give me that information, others say they can't share it.

我不明白这一点。

I don't understand that.

我总是觉得，哦，你们自己也不清楚。

I always take that as, oh, you don't know either.

所以你们只是借着‘我们不能分享’这个借口来掩饰。

So you're just hiding behind this facade of, well, we can't share that.

对。

Right.

我非常喜欢。

I love it.

所以我的理解是，沟通非常重要，之后要通过邮件跟进，并提供支持这些沟通的文件。

So what I'm hearing is like communication is really important, following up on that communication through an email and then having documents that back that communication up.

我想补充的另外一些资源是，一定要记住人们有不同的沟通风格。

A couple other resources that I'd like to add is I think always remember people have different communication styles.

我记得很多年前做过一个工作坊，当时说有些人是红色风格，比较直接；有些人是黄色风格，更社交；还有绿色风格，更友好；以及蓝色风格，更注重数据。

So I think I remember doing like a workshop many years ago where they said some people had like a red style, they're more direct, others are more yellow, more social, and then there's green, which is more friendly, and then there's like blue, which is more into the data.

因此，理解对方是谁，并根据对方调整自己的沟通方式，非常有帮助。

So kind of understanding who the person is on the other side and kind of adjusting your communication style to that person is is really helpful.

另外，我想提到一本我几年前读过的很棒的书。

And then another resource I'll say, there's an awesome book I read a while back.

这本书叫《Exactly What To Say》，作者是Phil M。

It's called Exactly What To Say by Phil M.

琼斯。

Jones.

这本书实际上是为销售人员写的，但我认为你在日常生活中也可以使用。

It's actually meant for salespeople, but I think you can use it even on a day to day.

他提供了一套23句话，你可以在与人沟通时使用。

He gives like a set of 23 phrases that you can use when you're communicating with people.

所以，强烈推荐你去看看这本书。

So again, like definitely check out that book.

我从你购买这本书中得不到任何好处，但我认为它会对大家很有帮助。

I have nothing to gain from you purchasing the book, but I think it'll be a great resource for people.

好的。

Okay.

那么，有没有什么沟通策略，比如早期的介绍性通话或共享模板，你觉得在早期对齐期望方面特别有效？

So, there any communication tactics, like early intro calls and shared templates that you found to be particularly effective in aligning with expectations early?

我知道我们之前已经提到过一些相关内容。

I know we touched on some of that.

海蒂，你在我们会前通话中提到了这个问题，所以我想让你来回答这个问题。

Heidi, you brought this up during our pre call, so I wanted maybe you to start that that question.

是的，当然。

Yes, definitely.

当我们首次联系赞助方的CRO时，会由我们的启动协调员发送一封邮件，我可以这么说，这是一封写得非常出色的欢迎信。

So, when we're first connecting with a sponsor CRO, we have a startup coordinator send, and I'll just say it's a beautifully written welcome letter.

信中简要介绍了我们的机构，以及关于预算、监管和其他具体问题的主要联系人。

It gives a little bit of background on our institution, who our main contacts are with regards to budgeting, regulatory, any other specific questions.

信中还列出了关键里程碑，这对赞助方来说显然非常重要。

It also lays out key milestones, which are obviously important for the sponsor to know.

我们的机构会采取一些特定的步骤。

There's certain steps that our institution takes.

例如，所有文件定稿后，我们会进行一次内部文件一致性核对会议，以确保知情同意书（ICF）的措辞与预算和合同保持一致。

For example, once all the documents are finalized, we do our own internal document congruency call to make sure that ICF language lines up with budget and and the contract.

因此，在这封信中提供这样的整体框架，确实有助于明确并对齐各方的期望。

So, just giving that overall layout within this this letter is definitely helpful and aligns expectations.

我们还会连同管理费清单以及其他我提到的、印在信头纸上的信息一起发送出去。

We send that out in addition to the admin fee schedule and other bits of information that I mentioned that are put on letterhead.

我非常支持在早期进行一次介绍电话。

I'm a big fan of the early introduction call.

有时候，甚至在我打开预算、合同或查看方案之前，我就想主动联系赞助方和CRO，也就是我在谈判中将要合作的人，向他们介绍一下我自己。

Sometimes before I even open the budget or the contract or even look at the protocol, I want to reach out to the sponsor and the CRO, whoever I'm gonna be working with in the negotiation and tell them who I am.

这样可以让对方在邮件之外听到一个声音，也许看不到脸，但至少知道发邮件的不是一个冰冷的邮箱地址。

That way it puts a voice, maybe not a face, but it puts a voice with the email, and I'm just not some email that's sitting in their their inbox.

我也会利用这个机会告诉他们，就像海蒂说的那样，如果需要来自研究中心的任何信息，可以联系一到两个人。

I also use that as an opportunity to let them know kinda sorta like what Heidi was saying that if you need anything from the site, there's one or two people that you can reach out to.

如果研究中心只有一个联络人，我会提前告诉他们：嘿。

If the if the site has a single point of contact, I tell them upfront, hey.

如果有什么需求，直接联系这个人，他会把问题转达给相关的人。

If you need anything, you reach out to this person, and that person will route it to wherever it needs to go.

我也曾向赞助方和CRO提出过这个建议，他们都认为这是个非常好的想法。

I have brought that up to sponsors and CROs as well, and they have all thought that's a great idea.

我就想，你们那边能不能也实施一下呢？

I'm like, well, can you implement it on your side as well?

因为回到沟通这个话题，不一定是预算方面，很多时候在沟通上，站点可能不知道，如果我的监查员没有回复，我该找谁？

Because going back to the whole communication thing and not necessarily when it comes to budgets, a lot of times when it comes to communication, sites might not know if my CRA isn't responding, who can I go to?

我知道在行业里不久之前，出现了一个新角色叫站点联络人，这是赞助方或监查员级别的一个人，不管遇到什么问题、什么疑问、什么状况，我们都可以找他，他会内部转达给赞助方或CRO。

I know in the industry not all that long ago, there was this new thing called a site liaison, and this was someone at the sponsor of the CRA level that we could go to no matter what the problem was, no matter what the question was, no matter what the issue was, we'd go to that one person and they would route it internally at the sponsor or the CRO level.

所以对我来说，早期沟通和至少有一个单一联络人，无论赞助方或CRO需要什么，都能找到他。

So for me, early communication and having at least one single point of contact for no matter what the sponsor or the CRO might need.

另外，在这些早期沟通中，如果你在过去两年内经常与该赞助方合作，可以提一下之前的方案，看看是否

Going off of them also, in those early communications, if you work with that sponsor regularly within the last two years, mention that other protocol, see if you

可以

can

去

go

直接问他们：嘿，能不能发我一份已经包含之前批准费用的预算？

ahead and just ask them, hey, can you send me a budget with the fees previously approved already added into it?

我很喜欢收到这些。

I love getting those.

我会为你这么做。

Will do that for you.

这有助于加快进度，这样你就已经跳过了从之前协议中那一轮谈判的阶段，可以直接看到已批准的费用，我发现这确实能大大加快进程。

And that helps speed things along, so then you've already past the level of that original round of negotiations from that previous agreement, you see the fees that have already been approved, and I find that that helps move things along a lot faster too.

这是个好主意。

It's a great idea.

对，接着你刚才说的，通过已签署的合同来推动进展。

Yeah, just to kind of piggyback off where you left off on a signed contract to move things forward.

现实来说，有时候这行不通。

Realistically speaking, sometimes that does not work.

我会遇到赞助方或CRO回来告诉我，别扫兴，但赞助方或CRO会说，每个研究都不同，所以我们不能用这个预算。

I will have a sponsor or a CRO come back and say, you know, not to be the Debbie Downer, but I'll have a sponsor or a CRO come back and say, well, every study is different, so we can't use that budget.

我说，我明明一周前才执行过这个文件。

I'm like, I literally executed this document a week ago.

为什么我们必须从头开始？

Why do we have to start from scratch?

对。

Right.

好的。

Okay.

接下来一个是：研究机构如何在对申办方保持灵活的同时，保障自身的运营可持续性？

So the next one is, how can sites strike a balance between being flexible with sponsors and protecting their operational sustainability?

也许马特，你先来谈谈这个？

Maybe Matt, do you wanna start with that?

我要回到一点：如果你是一个研究机构，你必须清楚自己的成本。

I'm gonna go back to, if you're a site, you have to know what your costs are.

如果你不知道自己的成本，就不会把这些成本纳入预算，如果你不把真实成本纳入预算并确保它们得到覆盖，我看不出你如何能保持可持续性。

If you do not know what your costs are, then you're not putting that in your budgets, and if you're not putting your true costs in the budgets and making sure that they're being covered, I don't see how you're gonna remain sustainable.

是的，我来补充一点。

Yeah, adding on to that.

所以我通常会内部创建两到三个版本的预算。

So, I always create I usually have two or three versions of the budget internally created.

首先，我会做一个底线预算。

So, first out, I'll do a bottom line budget.

这基于我们的内部收费清单，但费用非常低，采用的是医保费率，并且对人力时间成本采用最低的时薪，通胀率也很低。

So, that is based off of I mean, we have our own internal charge master, but the the fees are very low Medicare rates with with minimal inflation, low hourly rates for time and effort items.

这基本上是做这个临床试验时勉强维持的最低限度预算。

It's basically bare minimum scraping by if if we were to to do this clinical trial.

如果我的谈判进展能接近底线数字的50%，那就是一个预警信号，我会与临床团队的领导们讨论。

Now, if my negotiations ever gets maybe even 50% close to that that those bottom line numbers, that's an escalation point for me that I'll I'll discuss with my leaders in the clinical team.

因此，在谈判前明确底线数字至关重要。

So so knowing that bottom line is definitely imperative when going to negotiations.

当然，这些并不是我谈判时提出的数字。

Those are, of course, aren't the numbers that I enter negotiations with.

我还会准备一个中等预算和一个最高预算，然后提交最高预算。

I'll do a middle tier and a top tier budget as well, and deliver the top tier.

我觉得我好像把我的秘密都泄露了。

I feel like I'm giving my secrets out.

把我的最高预算提交给申办方。

Deliver my top tier to the sponsor.

但所有这些理由都存在：小时费率以及我们为成功高效地开展这项临床试验所需的一切。

But again, all that justification is there, hourly rates and what we need to do this clinical trial successfully and efficiently.

所以当你说到提交最高预算时，你是说你会先提出最高的金额，对吗？

So when you say give your top tier, you'll start with the highest amount first, is that what you mean?

是的，我把这叫做我的夸大预算。

Yes, I call it my inflated budget.

所以我们会使用最高的小时费率，在时间和工作量上更慷慨一些，也许还会预留一点余量，以防某些访视时间延长。

So we'll use our highest hourly rates, be a little more generous on time and effort, maybe build in a little bit of flux if if some visits could run longer.

因此，在这些最高预算中，我们会多加入一些内容，我这么说吧。

So there's there's a little bit more that we put into those top tier, I'll say, So

所以如果在场有人做笔记，他们可以给你发邮件，知道他们第一次发给你的预算，根本不用打开文件。

so if people that are taking notes here, you know, they could send you an email and they know the first budget they got to you, they shouldn't even open the file.

他们应该直接去找你们内部的人，至少在本播客上线前的几周内保持联系。

They should just go to the say, Can you just send me your guys have an insider here, at least for a few weeks till this podcast goes live.

好的，马特。

Alright, Matt.

这让我想到一件事，稍等一下。

So, that caused me to think of something to give a moment.

克里斯滕，我在理清思路的时候，你有什么要补充的吗？

Kristen, do have anything to add while I I get my thought back?

没有。

No.

我的意思是，我已经告诉过各研究中心了：我想为你们所做的工作支付报酬，但我们都清楚，实际情况各不相同。

I mean, I have told sites, I wanna pay you for the work that you're doing, but it we all know it varies.

一个研究中心的情况和另一个研究中心可能完全不同。

What one site can completely different from another.

你知道的，即使在同一项研究中，我收到的费用差异也很大。

You know, the fees that I get in vary greatly even on one study.

所以，给我解释一下这些费用是什么，把相关文件发给我，让我们试着找到一个平衡点，让大家都满意。

So, explain to me what these fees are, send me that documentation so that we can try and find that balance to make everyone happy.

好的。

Sure.

或者更快地将药物送达受试者手中。

Or get the drug to the subject faster.

好吧，所以那个神经元终于醒过来了。

All right, so that neuron decided to wake up.

我的背景其实是公共卫生领域。

So my background is actually in public health.

在进入研究领域之前，我曾在公共卫生领域工作了五年，主要接触的是代表性不足、没有保险或保险不足的人群。

I worked in public health for five years before I got into research, and I worked with underrepresented, uninsured, underinsured populations.

当我进入研究领域，开始深入研究预算和研究的商业层面时，我感到很不舒服，因为我们正在将人们的痛苦和苦难商业化——如果我要说得夸张一点的话。

So when I got into research and I really started getting into the budget side and I really started getting into the business side of research, it made me feel dirty that we were monetizing someone's pain and suffering, if I wanna be dramatic.

但如今，当我与研究站点沟通时，我会告诉他们：我们看到患者或研究参与者时，并不是在看美元符号，但临床研究的这一部分确实是一项商业活动。

But now as I talk to sites, I tell them, not that we're seeing dollar signs whenever we're seeing a patient or a participant in a study, however, this part of clinical research, it is a business.

所以，你可能会觉得这样想让人不舒服，但与此同时，如果你不覆盖成本，不执行能维持可持续性的合同和预算，那么你很可能不得不关门大吉。

And so, it might make you feel dirty to think of it that way, but at the same time, if you are not covering your costs, if you're not executing contracts and budgets that maintain your sustainability, then it's quite possible that you're gonna shut your doors.

如果你的门关上了，就没人能从这项研究中受益，也没有任何东西能推向市场。

And if your doors are closed, then no one is gonna benefit from that study, and nothing is gonna get to market.

这正是关键所在，马特。

That's the golden nugget, Matt.

没错。

Absolutely.

我职业生涯的大部分时间都在与申办方公司合作，我知道他们在其他领域存在大量浪费性支出，却不愿支付站点费用。

You know, I've worked with a sponsor company for most of my career, and I know there's a lot of wasteful spending happening in other areas where they're not paying sites, but they're spending in other areas.

因此，我完全支持站点应该为所提供的服务争取合理且坚实的补偿。

So I'm all supportive of, like, sites should, like, demand for really solid compensation for the services that are being provided.

归根结底，我认为如果你是申办方——我并不是想鼓吹这种想法，但这就是我看待问题的方式：这钱其实不是我的，我认为如果你给人们合理的报酬，就能获得高质量的数据，也能让相关人员完成你作为申办方所期望的工作。

And at the end of the day, I think if you're a sponsor, I'm not trying to promote this mindset, but that's kind of how I think necessarily, like it's not really my money and I think if you pay people well, then you get good quality data and you get, the people will do the work that you're looking for as a sponsor.

因此，预算上不要太吝啬，实际上对整个生态系统是有益的。

So, not being too stingy with the budget is actually healthy, I would say, in the ecosystem.

还有别的吗？

Anything else?

好的，完美。

Okay, perfect.

那么，我们来结束这个对话，然后开放提问。

And so, wanna wrap this conversation up and then open up to questions.

所以，我想让这个环节更有趣、更生动一些。

So, I wanna Kinda wanted to make this more fun and interesting.

这样你们能更好地了解这里的人。

So, you get to know the people here much better.

所以我的问题是，有一个对你思维方式产生重大影响的资源是什么？

So, my question is, what is one resource?

它可以是一本书、一个播客、一份期刊，或一个视频。

It could be a book, a podcast, a journal, a video, that has shaped the way you think.

那么，我们先请克里斯汀分享，然后是马特，再是海蒂。

So, maybe we'll start with Kristen first, and then Matt, and then Heidi.

对我来说，是一本书，《不较劲的微妙艺术》。

For me it was a book, The Subtle Art of Not Giving a F.

它真的帮我减少了焦虑，不再对每一个决定都过度分析，只是告诉自己：一切都会好起来的。

And it just really helped me not be so anxious and overanalyze every decision and just, it'll be okay.

我们能解决任何问题。

We can fix anything.

我们能让它行得通。

We can make it work.

归根结底，我们是在帮助人们多一些时间陪伴家人。

And at the end of the day, we're helping people get more time with their families.

一项临床试验让我多有了十三年与父亲相处的时光，我对此非常感激。

A clinical trial gave me thirteen more years with my dad, and I'm very grateful for all of that.

所以，能顺利走到终点，过程中还不至于恐慌发作，真是太好了。

So getting to the end game and not having a panic attack in the process is great.

我的资源比一本书或一个播客更不寻常，但塑造我思维方式的是：我可能要情绪化了。

So my resources of is a little more unconventional than a book or a podcast, But what shaped the way I think is I was I'm probably gonna get emotional.

我由在大萧条时期出生并长大的祖父母抚养长大。

I was raised by grandparents that were born and raised during the great depression.

因此，我倾向于认为自己对事物、对生活、对如何对待他人有着截然不同的看法。

So I like to think that I have a very different perspective on just things in general, life in general, how you treat other people in general.

尤其是从我祖父身上，我形成了凡事都要公平透明的理念。

And I know especially from my grandfather came this idea of being fair and transparent in everything.

他就是那种会毫不保留、毫无保留地告诉你一切的人。

He was one of those guys that to a fault, he would just tell you everything.

从来没有什么是被隐瞒的。

There was nothing that was ever hidden.

所以，我以前从未认真思考过这一点。

And so I had and quite honestly, I had never thought about it.

谢谢你，库纳尔。

So thank you, Kunal.

我从未以这种方式思考过，但我的很大一部分性格，源于我被抚养长大的方式，特别是由在大萧条时期出生的祖父母抚养长大的经历。

I never thought about it in that way, but a large part of who I am is because of how I was raised and how I was raised by grandparents that were born during the Great Depression.

我将这种近乎固执的公平与透明带入了临床研究，无论与研究站点合作时，我都坚持这样做。

And what I brought into clinical research is the fact that to a fault, I try to be as fair as possible and I try to be as transparent as possible, and so when I am working with sites, it's the same way.

就像我刚才说的，如果你公平且透明，那就没人能挑你的错。

And like I was saying a while ago, if you are fair and if you are transparent, then no one can call you out on it.

你可以为你的要求提供依据，因为数字以及你用来分析这些数字的数学方法是不会说谎的。

You can justify what you're requesting because numbers and the math that you use to write with those numbers does not lie.

我不知道该怎么接下去了。

I don't know how to follow that up.

马特。

Matt.

谢谢，马特。

Thanks, Matt.

我也会推荐一本书。

I will share a book rec as well.

这本书叫《好女孩得不到角落办公室》。

It's called nice girls don't get the corner office.

房间里都是男性，你也可以读一读。

It's males in the room, you can read it as well.

它确实有助于提升实际与战术性沟通、商业世界中的正念意识以及整体自信。

It definitely helps with practical and tactical communication, mindfulness awareness within the business world, and overall confidence.

我大概八年前或十年前读过这本书，但它一直让我印象深刻。

I read it, I mean, eight or ten years ago, but it definitely stuck with me.

而且，我确实推荐这本书。

And, yeah, I definitely recommend it.

很好，非常感谢。

Great, thank you so much.

我不是小组成员，但我有一个推荐要分享。

I'm not the panelist, but I'll give you a recommendation that I have.

它来自临床试验领域。

It's from the clinical trial landscape.

这本书叫《一只叫吉姆的马》，我知道名字听起来很奇怪，但确实叫《一只叫吉姆的马》，我认为这是一本临床试验手册，由杜克临床研究中心出版。

It's a book called A Horse Named Jim, and I know it's like a really strange name, but it's called A Horse Named Jim, I think a clinical trials manual, it's by Duke Clinical Research.

这是一本了不起的书，我一直在试图联系作者，我觉得他们搬走了，我联系不上他们。

It's an amazing book, and I try to track down the authors, I think they moved somewhere and I can't get hold of them.

但他们创建了一个非常棒的资源，你可以在亚马逊或任何卖书的地方买到。

But they have this amazing resource that they have created, you can get it on Amazon or wherever books are sold.

我知道很多人，我知道你们是临床试验运营领域的赞助方，我认为这本书会非常对你们有帮助。

I know a lot of people, I know you're site sponsors in basically clinical trial operations, and I think this book will really serve you well.

如果你正在填补生态系统中的新知识空白，它会帮助你理解这些知识缺口。

And if you're adding new knowledge gaps into the ecosystem, it will help you understand those knowledge gaps.

所以，如果你团队里有新员工加入，鼓励他们读这本书。

So, you have new staff starting on your team, encourage them to read this book.

他们会学到很多东西。

They'll learn a lot.

说到这里，我想我们可以开放提问了。

With that being said, I think we can open up to questions.

我希望我们能有很多问题，因为如果没有，我就得用我准备的备用问题了，而我真不想那样做。

If I hope we have a lot of questions, because if we don't, then I'll go to my backup questions, which I really don't want to do.