Beyond Regulatory and HTA Success: Reaching Physicians and Patients

We statisticians play a significant role in the clinical development of pharmaceutical products and medical devices. Many of us focus on designing and analyzing clinical trials to provide evidence for regulatory approval and Health Technology Assessment (HTA). In these set-up, we often talk rather directly to our external clients – regulators and payers (at least the big ones).

This looks very different in medical affairs. Just for the sheer number of clients (and other reasons) we statisticians rarely get the chance to communicate directly with physicians, caregivers, and patients. And we need to convince these as this is really the last hurdle for pharmaceutical products. 

Our communication with physicians and patients often relies on multiple layers such as publications, slide sets, promotional material, and sales representatives. Poor communication of data can lead to misunderstandings, harm patients and even lead to legal issues. We statisticians can have a big impact for the better here.

In this episode, I discuss how you can have an impact on physicians and patients beyond regulatory and HTA approval. 

In this episode I also refer to The Effective Statistician Launch and Lifecycle Program.

And, I talk about the following points:

  • Understand the physician and patient’s perspective to effectively communicate data.
  • Emphasize the meaningfulness of data in communications for informed decisions.
  • Contribute to the education of sales representatives to promote products.
  • Strategize the presentation of data for clarity and understanding.
Listen to this episode now and share this link with your friends and colleagues!


[00:00:00] Alexander: Welcome to another episode of The Effective Statisticians. This one is, again, a short one with no intro, no outro, just me talking for about a specific topic.

If you’re working in phase three and beyond. Then there is one area that you should really be aware about, and that is Medical Affairs. Why is medical affairs actually so important? In the end, it’s not about regulatory approval. It’s also not about winning HTA, it’s also about these two things.

In the end, the last hurdle. That you need to pass on is you need to convince physicians, caregivers, patients, to prescribe and track your truck. That is the last and ultimate hurdle. Now, how do we convince patients and physicians, caregivers, could be parents, or could be the kids of the elderly that we want to help. How do we convince them? How do we actually get to them? The interesting part here is that we as statisticians, rarely talk to them directly, nearly never. Whereas if you think about regulators like say FDA or the email or big HTA agencies like the G B A in Germany, the Hush in France, the NICE in the UK, and so on very often will be directly involved in the industries that often to them, or at least I hope statisticians are involved in there. If you’ll have nobody involved in there from the statistical side, then I think you’ll also have some homework to do. But that’s not my point to today. I wanna focus on this last parts of physicians, the caregivers, and the patients.

We rarely talk to them directly. We talk to them indirectly. Through many different layers. The first line of communication might actually start with a publication. Then these publications is picked up by someone creating a slide set from it. Then the slide set might be create, picked up by a local affiliate.

This local affiliate is then using the slide that sending it to an external marketing agency. They make it look pretty create promotional material, and then this promotional material is handed to sales rep and they actually then talk to a physician director. So there’s many different steps in many companies. Statisticians have only influence on the first step, the publication and sometimes in that influence is quite limited. So how do we ensure that the physicians and the patients actually have the right data at the right time in the right format? To make the right decisions for them. We ourselves could be the patients or the caregivers. Have you ever looked into kind of material that physicians see to make a decision about our health or the health of our kids or the health of our parents?

It is often surprisingly. Bad. I’ve been in discussions where, legal got involved because, companies were suing each other in terms of what to say and what is not to say in the promotional material. And that can happen actually quite a lot. Why? Because we as statisticians don’t have a good influence. We are sometimes completely blind to what is happening. We don’t even know that. We don’t know.

This is an awesome opportunity to have a big impact, not only to correct problems, but also to improve the communication. To say here, if you wanna make this claim, there’s much better data to use. If you want to use that claim, I think we should use a different figure. Here’s some additional data you can use to make the claim and make it more robust, or all these things are really important.

They are very important to the company. Look where the majority of the company money goes. Does it go to r and d or does it go to marketing and sales? And I’m pretty sure that your marketing and sales budget. Is much bigger than your r and d budget, much bigger. And the r and d budget very often even includes things like medical affairs, which is actually not so much scientific, is actually much more commercial function.

Okay. So it’s working in medical affairs might disagree, but it’s commercial in the sense that it works really directly with commercial. So if there’s much more money going in that direction, what do you think is a priority of the organization? Of course, the priority is where most of the money goes. Any money that is spent on the marketing and sales side. Will have direct influence on the company’s bottom line, of course, on the r and d side as well. But that may come years later or may ne never be realized. Lots of senior people want to see return on investment within months, not within years. They are measured on it. If you can help in this area, you will have a much, much bigger influence as a function. If you’re not already working in this area as a function, then have a look into this in order to learn more about this really important. Area. I have a resource for you. Jenny Davenport and I created a course about medical affairs.

It is part of the Effective Statistician Academy, and you can just, head over to the show notes and look for it. Just go to Check out, the Academy and check there the Medical Affairs course. This course will give you an understanding of what medical affairs is about, how we as statisticians can have an impact, what success looks like in this area, and how you can reach it.

So check out this course. We will offer it only to a limited number of people at the moment because we want to have a small group that really helps each other and it will be very interactive. We have some videos that are just view on demand, and we also have lots of group discussions.

So check out this really good course. I’m so happy about it. I’ve together with Jenny distill over 30 years of experience into this course, and it really answers all the most burning questions for this really important area. So check out the course and become an effective statistician.

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