- Do you know what TransCelerate does for statisticians?
- Do you write study protocols, analysis plans, and programming specifications as individual documents noting, that there’s lots of redundancy?
- Do you wonder, if there’s a more efficient way in line with what regulators want?
Pepa Polavieja will provide you with answers to all these questions in this episode.
Featured courses
Click on the button to see our Teachble Inc. cources.
Pepa Polavieja
Pepa Polavieja is a biostatistician with 22 years of experience in the pharmaceutical industry, working across early and late stages and many therapeutic areas, performing varying roles. In the last 15 years, Pepa has been working for Lilly, having different roles in the Global Statistics and Sciences organization. She was a group leader for the European group neurosciences team, driving the statistical activities around launch preparation, most recently she is in a global role as a consultant in quality operations, leading the implementation of improvement initiatives for the Biometrics organization.
In the last year, she has led the TransCelerate workstream focused on developing a Common Statistical Analysis Plan template, highly connected with the Common Protocol Template.
Outside work Pepa enjoys her big family of four kids, traveling around the world, cooking, reading, going to see live bands, and, of course, dancing with their music.
Transcript
What is TransCelerate and how it will impact your work tremendously
00:00
You are listening to episode number 46, what is Transcelerate and how it will impact your work tremendously, an interview with Pepper Polaviecher. Welcome to the Effective Statistician with Alexander Schacht.
00:19
and Benjamin Pisgill, the weekly podcast for statisticians in the health sector designed to improve your leadership skills, widen your business acumen and enhance your efficiency. If you are listening to this timely, there’s a last chance to register for the great free webinar on leadership. The topic is four reasons why statisticians fail to lead and how to overcome them.
00:46
Act now, sign up at thee slash webinar and don’t miss it. So today in this interview we talk about Transcelerate. What is it actually? Who will be affected by this initiative? How will this change your day-to-day work? What’s the view of the regulators and payers on this is? And where do you can learn more about Transcelerate?
01:15
Finally, we’ll also talk a little bit about the PSI conference that is coming up in London this year and what you will learn there from Transcelerate.
01:27
This podcast is created in association with PSI, a global member organization dedicated to leading and promoting best practice and industry initiatives. Join PSI today to further develop your statistical capabilities with access to special interest groups, the video on demand content library, free registration to all PSI webinars and much much more.
01:57
and become a PSIM member.
02:11
Hello, thanks again for listening to the Effective Statistician podcast. Today I’m actually very proud that I’m interviewing a former supervisor of myself, Pepper Poehler-Wiercher, and she recently took over a very, very interesting role in Transcelerate. But first, Pepper, please introduce yourself. What have you been done up to now and what was your career as a statistician?
02:41
has that looked like up to now? Yeah, so thank you very much for inviting me to talk with you in this podcast. I’m very excited about being part of it. So my name is Pepa Polarieja. I am from Spain. I am a statistician by training. So I’ve been working for
03:05
25 years more or less already. I don’t like counting so it might not be perfectly. So of those, the last 15 years I’ve been working for Lilly. So after I came out of university I started working in different CROs, TPO’s as a statistician where I was doing data management, a bit of data management and statistics.
03:29
And I had the opportunity to very soon began leading some of those statistics and data management departments and the CROs that I was working with because there was not that many people that had the experience and I was just happening to be there with the experience, with the passion. And I spoke English, which there was not that many statisticians at Spain that spoke English at the time. So I very quickly got into different big CROs to…
03:57
developed the data management and statistics department at Spain. And after that, I didn’t really ever have the opportunity of being part of a team with other statisticians that I could learn from. So when the opportunity nearly came up, although it was kind of coming down because it was from leading a group of almost 20 people and having built it, I came back to being a project statistician working in trials, just focusing on that.
04:27
As an individual contributor. As an individual contributor, which is, I think it was a very good step for me. And because I went so fast into the administrative part that I didn’t really have the time to focus on that. So during a few years I was working for the Spanish affiliate, which at that time had a lot of budget for doing different projects. So that was probably the most productive time of my career.
04:54
as a statistician where I had many manuscripts and I was working across different therapeutic areas so it was really a learning period. And I’ve been then working in different roles, so first it was at this local kind of support role, then I became a group leader for the European team, that’s the time where I got the opportunity to work with you, but it was more focusing on therapeutic area and medical affairs.
05:22
And in the last four years, I had the opportunity to work in a role that was more related to process improvement. And so that’s what I’ve been doing in presently. But really process improvement all around statistics. All around statistics. Yes. So you never lost touch of statistics. You were always working with statisticians.
05:47
but really more on the process improvement, quality improvement side of things. Yeah. Okay. And so that actually leads quite nicely into this job at Transcelerate, so to say. It’s not really a job, but how did you get involved with that? Why were you approached to take that on? Or did you kind of…
06:14
seizes opportunity and brought yourselves into it. So being completely honest, it came to me. In this role that I’m taking now, I work with departments within Lilly that are the ones that own the procedures and the processes. And they are very involved with external activities as well. So one of the persons that I work very closely with happens to be…
06:44
Well, she became the Transalary Representative at Lilly. And there were these new projects coming up. And one of them was creating this statistical analysis plan template. And now I will explain how that role became bigger. And she thought about me because I was already focused on processes. But I also have been working as a statistician. And I do have a good network as a statistician. So.
07:11
And she proposed me, do you want to participate on an external initiative with Transalaria? And at the beginning I was told this is about creating an SAP template, and it’s going to be what they call a sprint, which is a very quick project that you develop. You just have a set timeline and you deliver what you can create in that timeline. So I really liked the idea and I accepted, so that is how I became the work stream leader.
07:40
So I was involved in selecting the team from the different companies and we can talk now about what is Transcelerate. Yeah, let’s start with you. Let’s start, stop back and what is actually Transcelerate? What is a bigger picture? And there’s lots of things going on and that maybe some higher level introduction and then kind of how’s your specific project links into that. Yeah.
08:06
So Transcelerate is a not-for-profit entity created to foster collaboration across the industry. The vision that it has is to improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies. So it started in 2012, that is when it was founded. At that time there were ten member companies, so it is…
08:34
It is composed by pharmaceutical companies that they participate as part of Trans-Hilary by donating either money or resources. And there are certain rules that each company that are participating need to comply with in terms of how much resources and how much money they contribute with. They started out with five initiatives. But today,
08:59
six years later, the number of member companies has increased to 19. And something that I learned while being part of Transcelerate is it doesn’t sound like a huge number, but when you look at it in terms of how much research these 19 companies are doing, it’s about 95 or 98. I mean, it’s really crazy number of the research that is being done globally is done by these companies. So basically in.
09:26
includes all the major players in the field. So be it Novartis, Pfizer, Roche, GSK, whoever, you from Lili, everybody that is on this long list is really included. Okay. So today there is more than 25 initiatives going on. So it is really getting really huge in terms of what they can do. And yes, there is…
09:54
You have mentioned many of the companies that are already part of Transcelerate and it involves many people up to more than 1,000 people. And it’s also around the world. I mean, the country network expands to 22 countries and then there is a lot of engagement with…
10:20
health authorities and I can tell a bit more on the specifics of the SAP how that is happening. There is a lot of external collaboration. I was talking about the industry that is part of it, but there is also a lot of collaboration with CROs, with standards associations like CDIs, DIA, and of course with the health authorities.
10:47
So health authorities, especially kind of FDA, EMAR, the Chepatinis Authority. PMDA, yeah. And also like the ICH group, there is. Okay, yeah. So there is like three main pillars that Transalert is working on. There is one that is the one where the Statistical Analysis Plan template is landing, which is about harmonizing process and sharing information.
11:17
There are other interesting projects for statisticians in that area, which is digital data flow and placebo and standard of care database. So that is more for if you think about historical controls, things like that, or shared placebo stuff. So there is a database and this is one project that has been going for many years, so it’s kind of not in the development, so that is already working.
11:47
where there is a database with anonymized data from the different companies on placebo and standard of care. So that is something that as a member company you can use to simulate data to many different things. So that is one of the pilars. The other pillar is enhanced sponsor efficiencies and drug safety. So there is a project there
12:17
are also interesting for us, like data monitoring committee. This was another experience that happened this year, which was about creating a database of investigators or statisticians that can be part of data monitoring committees. Because what we have realized as an industry is that the people that is usually part of the DMCs, they are always the same, and they are getting older. And we need to bring.
12:47
fresh blood to this and it’s also a great opportunity to grow as professionals. So that is some of the work that they have been doing in that area. And we’re speaking about 2018 because as we are recording this, it’s end of 2018 and the podcast will go live actually early 2019.
13:10
Great. We’ve been realizing this. That’s a very good point. There are other interesting projects in the area, like advancing safety analytics. And then there is another pillar, which is about improve the pacing and site experience. That is probably the less interesting pillar for us in terms of what we can do there as statisticians or what resources we can use from that path. But I have to say that this is.
13:39
what is happening today. There is a lot of traction in terms of initiatives and because of the learning process that this organization has gone through, I can tell you that the pipeline for 2019 is looking very, very interesting for us as a statistician. So you will hear more, there will be more opportunities as we are thinking about digitalization, data flow and things in that arena.
14:04
So you mean pipeline in terms of new Transcelerate projects so that statisticians could participate in. So great to watch out for that. OK. So I think that in terms of what is Transcelerate, that is a good summary. You were asking how you can get information on that. If you work in one of the big pharmas,
14:27
there should be a representative of Transcelerate that you can connect with. And you can learn what projects your company is involved on. So try to find out from your medical department who is in your company part of the Transcelerate. You can always approach Transcelerate to understand in your company who is, but it makes more sense that you do it within your company. If your company doesn’t belong to Transcelerate,
14:54
Those resources that are created are not only for member companies. So, they have, if you search in the internet for Translate, you can find their webpage where there are a lot of resources that are open to everybody. You just need to enter some information and you can download those. And we’ll also put that in the show notes so you can also just go to the effe and check out the show notes for this episode. Okay, wonderful.
15:23
Okay, yeah. So let’s go back to kind of your specific project. Tell us a little bit more about the SAP template and things like that. Because…
15:40
If I first heard about it, SAP template didn’t sound really very interesting, so to say, but I think you’re more thinking beyond just a word file with a standard table of content. Let me take a step back, because we are talking about the SAP template, which in fact at the very beginning it was the project that we were involved on.
16:08
But then we realized that at the same time that this sprint on the SAP template was happening, there was also some work being done on the Common Protocol template, which has assisted since many years. And especially they wanted to improve the section or the standard section that they had on statistics. So we work on those two things together. But at the same time, and when you think about these templates…
16:36
they are not isolated. So in fact we are going through a process of rebranding because it’s not really that we are talking about templates. What we are talking is about a new way of developing design, designing studies. So essentially it is an automated way of describing the study design, bringing that information into the statistical analysis plan, and then bringing all that information into the clinical study report.
17:06
Because there’s a lot of redundancies there. If you think about, kind of, let’s say, the objectives of your studies, the hypothesis of your study, the methodological approaches there, there’s lots of redundancy between protocol, SAP, and the report in the end. Yeah. So essentially what we are calling it now is E-suite of templates. So it’s really that we have three templates where there is content reuse.
17:35
possibilities between them. So when you think about those templates there is two versions of them. There are the world versions and you can always use them and that will help you to have the same information at the same place regardless if you are Pfizer or Lilly or whoever you are. But you always have the opportunity to tailor that particular template to your needs so you don’t need to take it exactly as it is.
18:01
there is certain recommendations because they are not rules. This is not a standard. This is just a resource that you can use to the best. But really, the benefit of using it is that if you use the commonalities between it, that is what will bring that whoever is using it will be familiar with the information and will know where to find things. So going back to this content reuse,
18:30
which this template will give you if you are using the technology enabled, is that you can bring information from one place to another. So we are starting that journey to the vision that we have, to have a digital flow of information when we talk about protocol, SAP and clinical study report. And digital, we not just mean it’s…
18:56
PDF documents instead of printed out documents. Digital means it’s kind of… Metadata. Data that you can actually work with and that helps you to program things like metadata if you think of clinical trial data, things that describes volume or units or study code or stuff like that. Exactly.
19:27
How it works is that it has XML information behind it that you can bring from one document to the other. So in this case, we are using it to not copy paste the information from one document to the other. But if you think about it, I mean, the use can be all over the place. So can you start creating that metadata in a way that it will fit into the CRF so you can automate the creation of the CRF?
19:56
Or can you bring some of the information from your SAP so you can automate how you create specifications? So for example, if you think about the schedule of events that you have in the protocol, that feeds then into the CRF as well into the SAP. And from the SAP, it could feed into the programs. So that is not exactly a good example, because I don’t think the schedule of events at this moment.
20:24
I mean, for sure it’s not being brought to the SAP. I don’t know about the clinical study report. So I don’t know if that is a part of the XML. Endpoints kind of variables that you collect. Questionnaires, things like that. Okay. Okay, very good. So this was just a long response to your question about is this just a template? So that is one of the things.
20:54
we are transforming a board document into a database of metadata or a set of information. The other thing is that as a team, one of the things that we wanted to focus on is given the new ICH 9 addendum, is we wanted to bring this idea of the estimations into practice. So one of the things.
21:23
that you will find in the Common Protocol template and in this Statistical Analysis Plan template is a proposal on how you can describe where to fit all this information to define the estimates and to bring that concept into a plan. So it’s not just kind of hidden in the Statistical Analysis section, which most people don’t read, but it’s more…
21:50
really kind of embedded in the overall process. Yeah, so great that you made that point because one of the fights, well it was not really a fight because the rest of the team, the Common Protocol Template team was very keen to go that way, is we really wanted to have the estimates definition in the objectives and points tables. So maybe something that I can give you as a kind of hint is…
22:18
The most typical thing about the Common Protocol Template is that it has a table when you define your objectives and your endpoints. And they go in a format of a table, in a way that you link every endpoint to each objective. So it is a very initial step. But now what we have done, well, let’s talk about estimates instead of endpoints. And let’s have that in the objective section. So.
22:44
everybody realized that this is not really any statistical discussion. This is a team discussion. So that’s the starting point. Then that information, we bring it into the SAP. And in the SAP template, we’ll provide some examples of how you can summarize all the information with the estimates and the additional information on how you are going to analyze them. Nice. So I think that that is. Yeah. That really helps to bring this estimate.
23:10
concept out of the stats section, which I think is really, really important because if we always kind of keep it within the statisticians, we are never going to be successful with it. Yeah. So that is the first step, of course, is just a very small step, but we… I think that the other thing that is important to understand is this is…
23:35
our first proposal of the statistical analysis plan template. It was the first time that we were doing something like that. We only had like two months to develop what you will see. So we know that there is opportunity for improving. But I think it’s a really good start on how we can work on that. So when actually will we see these kind of things? When will that become publicly available? So the
24:04
New Common Protocol template, I think, is release 6. The Statistical Analysis Plan template and the Clinical Study Report template are going to be available in the Transareate page if it is… Roughly which kind of timeframe are we talking about? End of November, so in less than three weeks. So by the time you hear that, that should be live. Very, very nice. So let me make a point. So what is going to be available is the World Templates.
24:33
Because essentially what will happen is the technology enabled versions are going to come out as beta release. So it’s that for the common protocol template because that it was already there. So the common protocol template, you will be able to download the board version and the technology enabled version. For the SAP and for the clinical study report, you will need to wait a little bit more because we are going to give one year to the member companies to test it and use it.
25:02
until it becomes open for everybody. So if you are in one of the member companies, you can go to your Transcelerate contact and actually test it out? Yes, or…
25:16
I think there is going to be like, and I need to find out more about that, there is going to be like a form that you need to fill out because they want to know who is piloting it. Okay, of course. They want to have the guys have the feedback. So there is like a process of how you can access. Well, the ones that are available, you can go to the Translary page and download it. Although I will suggest that in any case, if you are a member company, you go, or if you are not a member company, you go to the people to understand how.
25:46
your company is adopting that template because as a company you can decide that maybe the common protocol template is having, I don’t know, only or for the statistical analysis plan template that there is not a section for clinical trial registry but my company has decided that that is something that is important and you can always add it. So it’s good to know, to understand how your company is adopting. Okay.
26:12
So things are moving forward quite quickly. That’s very, very good. And we talked about the timelines for that. And you mentioned at the beginning a little bit about ICH. So what’s happening in terms of ICH there? Yeah, so the ICH announced this summer that they are going to create a common protocol standard.
26:35
So the difference, just for me to highlight, the difference on what the ICH is going to create versus the template that Transaluate has out there. So what Transaluate provides is not a standard, it’s a resource. As a company, you can choose to use it or not. What ICH is going to create is a standard because they are calling it a standard. There is certain timelines that they need to follow because essentially once that they develop it, they need to put it into public for
27:03
period of time, I think it’s about one year almost, to gather comments and then after they look into the comments they can create that standard. So they are starting the work, I think next week is when they are getting together so the FDA is going to be there, many of the regulatory bodies, so they will be starting this new standard for the protocol template.
27:30
And many of the people in Transcelery that was involved in developing the template will be involved in that. I was told that one of the pieces that they are very interested on is to see how we have proposed to describe the statistical analysis in the protocol and in the SAP. So I will hear more about what are those discussions. And we estimate that next year there is going to be a lot of engagement with the regulators in terms of what do they think.
27:59
and how they perceive what we have proposed. Speaking about 2019, the PSI conference in London in June of 2019 is not so far away and actually you are planning something for that conference. Yes, so we are working with the committee to have a session very specific for statisticians not only on the SAP template but on Transcelerate.
28:28
and what Transcelerate can bring to the community of statisticians. So what are the projects that as a community we can benefit from? Where to find that information? We may be, we are defining it, but maybe to serve some success stories from some of the projects that have been going on for more time. And also talk about the future. What are initiatives that are starting that people may have an interest on and they can get involved?
28:58
Because, yes, as an example, for the SAP, we are already talking, well, now that we have a template, which the core information doesn’t make sense to create a library. So for the very typical analysis, can you grab a library and then you can have a draft SAP very quickly. So there are many things that are being under discussion on that area. Which makes our life as a statistician in clinical trials much easier, which is really, really nice.
29:28
and you’re listening to this in early 2019, just go to psieweb.org where you can find the conference homepage and register and still benefit from the early birthrate. If you’re listening to this a little bit later in 2019, still register for the conference. I’m pretty sure it will again be an amazing event like in 2018 in Amsterdam and the years before.
29:57
So thanks so much, Peppa, for that really, really nice overview. And I’m really looking forward for that. And as I said, you’ll find more information on the homepage, thee And yeah, come to the conference to find out even more. And Peppa will be there as well. So you can also probably catch her in a break and ask some further questions. Thanks so much. Thank you very much.
30:27
So don’t forget to sign up for the leadership webinar. Act fast. It’ll be awesome. And you don’t want to miss out on this one. Of course, as I mentioned, the webinar is for free. Just sign up at thee slash webinar. And I thank you very much for listening. Bye.
Join The Effective Statistician LinkedIn group
This group was set up to help each other to become more effective statisticians. We’ll run challenges in this group, e.g. around writing abstracts for conferences or other projects. I’ll also post into this group further content.
I want to help the community of statisticians, data scientists, programmers and other quantitative scientists to be more influential, innovative, and effective. I believe that as a community we can help our research, our regulatory and payer systems, and ultimately physicians and patients take better decisions based on better evidence.
I work to achieve a future in which everyone can access the right evidence in the right format at the right time to make sound decisions.
When my kids are sick, I want to have good evidence to discuss with the physician about the different therapy choices.
When my mother is sick, I want her to understand the evidence and being able to understand it.
When I get sick, I want to find evidence that I can trust and that helps me to have meaningful discussions with my healthcare professionals.
I want to live in a world, where the media reports correctly about medical evidence and in which society distinguishes between fake evidence and real evidence.
Let’s work together to achieve this.