Clinical Trials Transformation Initiative

A conversation with Executive Director Dr. Pamela Tenaerts

Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the "People Always, Patients Sometimes" podcast to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI.



Tom Rhoads (00:04):

Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. In an earlier episode of the "People Always, Patients Sometimes" podcast, we heard about the founding of the DiMe Society from Jennifer Goldsack. The organization was created by participating members of CTTI who wanted to continue their work on the impact of digital health on clinical trials. We thought you would like to hear more about CTTI, the Clinical Trials Transformation Initiative, so we invited CTTI's executive director, Dr. Pamela Tenaerts to join us on the podcast. The program is a public-private partnership is shaping how clinical trials are and must evolve to be more efficient and effective. You'll hear how CTTI is living its mission to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Thanks for listening to the "People Always, Patients Sometimes" podcast.

Janet Kennedy (00:54):

Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the podcast today to have a chance to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI. It's a public-private partnership whose mission is to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. My name is Janet Kennedy and I'm your host for the "People Always, Patients Sometimes" podcast, a production of Spencer Health Solutions. I'm really looking forward to my conversation with Pam on the podcast. Welcome to "People Always, Patients Sometimes," Pam.

Dr. Pam Tenearts (01:37):

Thank you, Janet and I'm looking forward to it as well.

Janet Kennedy (01:40):

I understand that CTTI has actually been in existence for quite a while and in the digital health space for about eight years or so. Is that correct?

Dr. Pam Tenaerts (01:51):

Yes. We were actually lucky enough to celebrate our 10
year anniversary in 2018 so we've been in existence a lot. We've started with
more general clinical trial improvements and then we are thinking more and more
about the trials of the future

Janet Kennedy (02:07):

What was the initiative for getting it started in the
first place?

Dr. Pam Tenaerts (02:11):

It was really a group that came together at the time. Remember, this is in 2007 is when we officially started and then we kind of developed an executive committee and went from there. But at the time there really wasn't anyone coming together to improve clinical trials and we really were looking at identifying practices that would increase the quality and efficiency of clinical trials. Over time, we have changed our mission to be more action-oriented because we realized that just identifying ways of doing things better doesn't really, it's not helpful enough for most organizations. So now we also drive the adoption of the practices by creating more tools and resources that can help with those recommendations that we create. Yeah. At the time, I think we were one of the only organizations in the field, and we've been lucky enough to have other organizations come along as well, such as MRCC and TransCelerate because there's really so much work to be done. You know, it's a good evolution for clinical trials.

Janet Kennedy (03:16):

I'm curious about the impetus for this though. Did it come
from pharma companies? Did it come from academia? Did it come from healthcare
itself?

Dr. Pam Tenaerts (03:27):

Lessons are that it came from conversations between Rob Califf and the food and drug administration people. And they were talking about how things should be better, how things should be improved. And the FDA decided to put some effort into actually doing something rather than just talking about it. When you bring clinical trials, individuals together, we start complaining a lot and talking a lot about how this could be better or how that could be better. But at the time nobody was actually doing anything about it.

So it was really sort of a call to action where then the food and drug administration created a memorandum of understanding with this university to set up this consortium. And from the beginning, it was clear that the only way we could get to solutions was by involving everyone. So from the beginning, we had organizations and individuals from across the enterprise representing academia, clinical investigators, government regulatory agencies, industry institutional review board, also patient advocacy groups. We've had patients in our efforts from the very beginning on our executive committee. We've also identified individual patient representatives that are folded into the steering committee. So we really bring everyone together and that's kind of how it started. It's a little bit of the Greenpeace model. You have to be part of the solution so I have a solution that is sustainable for the enterprise.

Janet Kennedy (04:53):

You know, I'm fascinated that from the very beginning CTTI
committed to having patients a part of the process and that seems to be
something that just now is being fully embraced, not necessarily done but
embraced by pharma companies and protocol designers and even conferences on
clinical trials. What do you think was really pushing the idea that patients
needed to be a bigger part of the process 10 years ago?

Dr. Pam Tenaerts (05:23):

I think it was really the understanding that patients are
a part of this is that participants in clinical trials are a part of some
people living with diseases that need medical solutions should be part of how
you develop them. When we first started, we had one representative on the
executive committee, so that is a body direction and sort of work on strategy.
We also had patients, individual patients voted into our member organizations,
but in 2000 we actually upped that and I think that's even before a lot of
these recent activities happened too. In 2013 we did a patient leadership
council where we invited individuals from patient organizations, so this is not
individuals but people representing groups like coma and things like that and
we asked them to be part of CTTI. We had created a separate body for them,
patient leadership council, so that's there a year or two Dave really asked us
to become part of the membership organization, so now about 20% of our members
are patient advocacy groups. Since then also every time we set up a project, we
used to have leaders on a project from industry, government and academia as
since 2013 patient leaders became part of our context as well. And I have to
say it's changed the way we did things for the better. We've learned a lot and
I think our recommendations have become even better than they were before.

Janet Kennedy (06:59):

I'm very interested in the part of your mission that talks
about improving clinical trial efficiency, not necessarily efficacy. So what
was inefficient about clinical trials that came to your attention?

Dr. Pam Tenaerts (07:13):

So at that time, CTTI was founded and I think it's still the case. There was his sunset clinical trials were getting more expensive and that maybe who was doing these. That does not add to the quality of data and integrity of data, which is sort of why we came up with our quality by design project as well. But the efficiency part is really addressing the complexity. Clinical trials are too complex and probably should not be as complex as they are to get to a reliable result. At the time, there was a sense that recruitment was slowing, which I think is still the case that recruitment could be better. Investigators were leaving clinical trials because it got too complex. This was also done at a time where the medical community really felt that we could use better evidence to was critical that we came up with a system that could provide this evidence in the most simple way possible to get the most reliable results that can be used for decision making.

Janet Kennedy (08:21):

And so you mentioned what the result of that was, the quality
by design program.

Dr. Pam Tenaerts (08:26):

So yeah, the very first project was monitoring, this is in 2008 and this was sort of thinking about all the ways people were monitoring and you know, some people monitor, a lot of people at the time monitor a hundred percent some monitored, zero and some did something in between. And we were really trying to understand, you know, why all these things were happening and what the best ways would be to make sure that you have data. Because that is really the goal of monitoring, right? To make sure that you have quality, reliable data on that PCC was maintaining. You're in the conduct of the trial. So what we found is that if we think we can build it in quality at the back end, we're a little bit mistaken, but we really need to think about quality and that is where quality by design and manufacturing, it's really setting up your system so that you have the least errors, to begin with. And so our quality by design is focused on areas that matter and it's sort of really getting us to recruit a call that is as simple every 10 the and not more complex than it should be to get you reliable data in a systematic way.

Janet Kennedy (09:45):

And as you develop these programs, who are they accessible
to are? How do you provide them to the industry?

Dr. Pam Tenaerts (09:53):

CTTI has a public-private partnership grant from the Food and Drug Administration, which is kind of unusual because they're not a grant creating organization. We are very keen on making everything accessible to everyone. So wild member organizations and people working on our team might have slightly earlier access. When we launched things like maybe we do an internal webinar before, once we've launched our recommendations, they become available to everyone on our website. So they are available to everyone. If people ask questions, we answered them, we help them.

Janet Kennedy (10:33):

Well, that's great. So all the things that you're developing, these resources are openly available to companies from your website.

Dr. Pam Tenaerts (10:41):

Exactly. And we encourage everyone to use them. And we've
actually started a use case library to sort of document in a systematic way how
people are using our recommendation members or non-members. It's open to
everyone because what we've learned is that people really like our
recommendations, but if you're trying to do something new, that's always hard.
Right? So what we've learned from our members is that, Oh, we really want to
use this, but it'd be so nice if we could see how somebody else has used this
first. So this library serves two purposes. First, collecting our impact and
selecting how people have used our recommendations, but then at the same time
it becomes a resource to other organizations who want to adopt our
recommendations or part of our recommendations. And we're hoping to create a
community that way that can together improve clinical trials after we've
launched our recommendation.

Janet Kennedy (11:40):

Oh, that's excellent. And this is an ongoing initiative.
How do you decide what projects you're going to work on or what kind of content
or programs you develop every year?

Dr. Pam Tenaerts (11:53):

Basically three ways in which we identify projects. One that is a partner with Duke University in the, in the partnership, the food and drug administration has an opportunity to ask us to do work. We call those. That's not the biggest part of our projects. The biggest part of our projects comes from members. So once we have the capacity, we go through an exercise with our members where we asked them what are they thinking about in clinical trials, what are their organization trying to solve? And we created a list of items. For example, last time around what came up was massive protocols people started to see across the enterprise and I remember around master protocols, pragmatism, and clinical trial diversity. So those were products that our members identified. Once we create that list, that is the benefit of membership. While our resources are available to everyone. The members do get to vote on what we work on.

Dr. Pam Tenaerts (13:02):

The last way is sort of something that I can recommend that and that might be an opportunity that comes up or something that we think is really worthwhile and then I recommend that none of the projects are actually approved until the executive committee decides that we should move forward with them. We think about approval of projects. We are very careful in talking to ongoing other initiatives to make sure that we're not duplicating work or that we're not doing things that they're already doing. Our project managers create concept sheets that include talking to experts in the field. Like I said, making sure that we're not duplicating efforts and sometimes it's a little confusing because we might have an on the surface, similar names, different aspects of that issue, like informed consent. We have done some work on a chest, had done some work on it, but we're actually doing very good things that we are very careful because again, we use a lot of federal money. You don't want to waste those tax dollars on things that our people are already doing. We also approved projects. They sort of think about the uniqueness of the strategic impact of clinical trials in the future and sort of the dislocation efforts and things like that.

Janet Kennedy (14:27):

Who does the actual work? Is this the members are joining committees to get involved or do you actually have staff there?

Dr. Pam Tenaerts (14:34):

It's a combination of both. We have a staff of project managers who get assigned these projects and they are really responsible for moving everything along and creating the framework for developing the project plan and things like that. But then reached out to our members. Every time a project has been approved by the executive committee, we send out a newsletter to our members and say, you know, just recently it was pragmatism in clinical trials and qualification of novel endpoints using global technology. So we send out an email, we say this is a concept we're going to be working on this, who would like to join? And then our members respond and then we create team leaders and the team leaders also have to come from member organization. So like I said, we kind of take a look at where while we kind of go for the academia-industry, government and patient advocacy, we also try to just look up a project and see what makes sense for government.

Dr. Pam Tenaerts (15:34):

It's important that both an NIH component and an FDA component, so once we identify the project's meters, now we also create a scene and then we supplement that team. Sometimes people that are not in our membership or people of organizations that like I said are not in our membership and that is needed for that project. When we work on projects and just people that are already getting paid by their organizations, we don't reimburse for participation on projects, but patients, individual patients, we reimburse for participating in our project so that everybody's on the same plane. So we're very careful about making sure that when you're sitting at the table around these projects, everybody has an equal voice and we see that that requires the individuals who might have to take time off from work to sit on project meetings for two hours or come to our meetings as they're working on the project. But then other people, sometimes academics as well because their lives, their life is a little hard VC and so they need to have research time that we reimbursed on their salaries.

Janet Kennedy (16:44):

I think that's wonderful. I really think that the challenge in having public-private partnerships and having industry leaders as a part of it is honestly for some of them it's easy to be there because their role is funded. It's just something they work into the workload. And the other thing is that it can mean that in many cases they're overly influencing what's happening. You know, I was on a consumer product safety committee and yet it was all made up of the people who manufacture the product. So there was no representation from the consumer at themselves. So it didn't make sense that the people building it. We're actually building our own safety regulations.

Dr. Pam Tenaerts (17:26):

Interesting. We're actually doing interviews with finished up project teams, so projects that have ended in the last few years. And one of the questions that are really important to us, if I were talking to representation from everyone on this project team, so patients in the streets, government, everyone. And one of the questions we're really sure of that we create that environment is, is your voice heard? Do you see like your boys have equal weight as everyone else's? Because that is I think, critical and moving the field forward.

Janet Kennedy (18:01):

I love it. Well, tell me about how does somebody actually
join if they want to be a part of CTTI. Is this an open organization anyone can
join and how does the fee schedule work?

Dr. Pam Tenaerts (18:14):

More and more talking about how to best engage with CTTI membership is certainly an option but might not be an option or might not be sort of the best path forward for everyone. People typically reach out to us or we have conversations with them to kind of figure out what the best way to participate in an organization like CTTI. Because for example, some companies might be really interested in one very specific topic of a project that we're working on, but not quite as much on the others. And then so we have other ways that they can engage as part of our projects. We do interviews that we do surveys, we do expert meetings. So for some organizations and people, it makes much more sense to engage that way. Where people and organizations that really work in the fields of medical product development and have the passion to improve clinical trials.

Dr. Pam Tenaerts (19:06):

This is obviously not a platform where you can sort of access people that you can sell something to. We are very strict on avoiding that kind of a situation because we really do want everybody to feel like they can and they're not going to be sort of approached about clinical trials as a product. We do a little bit of screening from that perspective, but if you're an organization that has is a very key interest in improving clinical trials and it is more than just about one particular thing and then a conversation is the first thing and then we can figure something out. Our fee schedule is online and has since 2007 since we started because when we started I talked about the memorandum of understanding the drug administration. So they basically said, we think this is a very good idea to start this, but we have no money. So at the time, the executive committee came up with a fee structure for people to join as members and it ranges from $70,000 for a global organization that has more than $20 billion in sales, to zero if you're an individual patient advocate.

Janet Kennedy (20:18):

Fabulous. Again, level playing field, you need to have the
commitment coming in that matches your ability to pay.

Dr. Pam Tenaerts (20:27):

Exactly. You know, it doesn't make sense for everyone to
be a number either because one, once you remember, we want to make sure that
that's a value proposition for you, that you get something out of it that is
not something that you do but you get something out of it that your people in
the organization get something out of it and you can contribute. Now having
said that, we don't need people that are complete experts, sort of, you know,
key opinion leaders. We also want people with boots on the ground. So a lot of
our projects include coordinators because you know the PII is one thing. A
coordinator on the ground has a very different perspective of how in their day
to day life.

Janet Kennedy (21:10):

That makes so much sense because that's where the
efficiency falls apart. Someone can have a grand idea for a project, but if
they're not the one implementing and saying, Hey, these two things aren't
matching up and they're not working, then they're not getting the kind of
information they need to make changes.

Dr. Pam Tenaerts (21:26):

Exactly.

Janet Kennedy (21:28):

Well, what about the longer-term vision for CTTI? Where do you hope to be in 10 years?

Dr. Pam Tenaerts (21:34):

Interesting that you ask that. We're actually working on a vision, we call it vision 2030 and really thinking about what clinical trial should look like 10 years from now with the idea that it should be achievable, but it should be a little bit of a stretch. So we're thinking about what they should look like and then also what we need to do to achieve that vision. Once we are finished with that exercise and we're hoping to have this done last spring, this here and we'll communicate about this of course, and then we want to ensure it's sort of a guidepost for our project activities at that point. We want to make sure that we work on projects that move the clinical trials ecosystem towards that vision. We're also hoping that our vision aligns with other people's religions, so there will be some work and figure that out.

Janet Kennedy (22:24):

Awesome. You know, one of the organizations that I have recently joined is the DiMe Society, the Digital Medicine Society, and I understand that that came into existence because it's really an extension of a CTTI project.

Dr. Pam Tenaerts (22:39):

I'm not sure I would characterize it that way, but Jen Goldsack, who was the project manager on our novel digital and mobile technologies ended up becoming the executive director for DiMe, so I'd like to think it has something to do with school lessons of different things that were going on in the world. Right. There's a lot of movement around mobile clinical trials and technology and clinical trials and there wasn't really his feet for what are really two very different industries. If you think about how technology and medicine to come together and they've provided a forum to create that and yes, I think it's very worthwhile. I'm on the scientific leadership board.

Janet Kennedy (23:26):

Well, I will tell you the Jen gives CTTI a whole lot of credit. When we did a podcast interview discussing the dimes society and they basically said they got inspiration from working on CTTI projects and felt that they wanted to continue after. You'll be proud to know that there are over 800 members in the organization now.

Dr. Pam Tenaerts (23:46):

You know Jen and I, we used to work together but we still
see each other a lot. We actually had to live in the same town and Florida, so
now we do yoga together.

Janet Kennedy (23:57):

How often do you make it up to Duke?

Dr. Pam Tenaerts (23:59):

We are the distributed team, so about half of the team are
remote and we are sort of dispersed from as far as Seattle to Sarasota, Florida
and then everything in between. So we're kind of dispersed. We go every month
or two days to sort of coalesce the team and bring all of us together.
Obviously a lot of our work is on the phone. I have to credit Andy Coravos for
doing more of our work on video conferences. We used to never do videos. I'm
starting to like it a little bit better when you talk. So internally we do a
lot more video conferencing. We do a lot of work on the phone. Obviously your
work on a project is on the phone. We do have sort of, uh, opportunities to
bring teams together, especially in the beginning so that we can make sure they
call a left swell because people have to get used to each other. You know,
understanding, learn who is voices and those kinds of things that we come
together for two days, once a month.

Janet Kennedy (25:04):

Oh, that's excellent. Well, maybe next time you're in town
I will get a chance to meet you in person.

Dr. Pam Tenaerts (25:09):

Oh, are you in Durham?

Janet Kennedy (25:10):

Oh, well I'm in Raleigh.

Dr. Pam Tenaerts (25:11):

Oh yeah, of course. Absolutely.

Janet Kennedy (25:15):

One thing I didn't ask you is about your background and
how you came to CTTI in the first place. Do you mind telling me a little bit
about your history?

Dr. Pam Tenaerts (25:24):

So I was trained as a general practitioner in Belgium and
after a couple of years of doing that, I started working at the university and
there's a funny story about that because the day of my interview with the
professor of cardiology, I started in cardiology clinical trials. I worked on
the Gusto study, which I thought every study was like this. Every clinical
trial that had 42,000 patients. That's how I got into clinical trials. But the
day of my interview, the professor asked me if I wanted to have dinner with the
American. He first said, do you want to have dinner at the faculty club where I
went to medical school and as a student, typically you don't have access to the
faculty club at all.

Dr. Pam Tenaerts (26:12):

And then it turns out to be with the Duke folks and Rob Califf that day. The first day I interviewed for a clinical trial job. And so Rob is a constant for many people in the clinical trials world. After I finished the two-year appointment I had in Belgium, I came over to the West to work on the American side of clinical trials in the coordinating setting and that's really how it got started. A couple of years later I left and in 2012 I started having conversations again and then back up at CTTI, which is sign of a nice culmination of different experiences I've had working at a large university in Europe leading the European center for a multicenter, huge clinical trial, going to pharma, going to Duke at the time, then to a community hospital where I ran a research center. Then I went back to a device company to run the European operations and then to Duke. So it was a nice combination of being able to provide solutions to all of the issues I had encountered over what was by then about a 20-year experience in clinical trials.

Janet Kennedy (27:24):

Thanks for listening to this episode of "People
always, Patients Sometimes" with our guests. Dr Pamela Tenaerts, the
Executive Director of the Clinical Trial Transformation Initiative. Thanks for
joining us, Pam.

Dr. Pam Tenaerts (27:36):

It was a pleasure. Thank you very much, Janet.