Director’s Update — April 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors.

Below, Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.Karl Kieburtz, M.D., M.P.H.

The new leadership structure has been in place for three months now. How are things going?

One of the great things about the change in leadership structure is it allows each of us to direct ourselves with more emphasis toward specific areas, and one of the things I’ve focused on is trying to understand what’s happening lately at NCATS. Right now, they’re very focused on the development of new methodologies and new technologies to increase the efficiency of clinical and translational research.

In research, there’s a very long window from discoveries in the lab to treatments in humans and actually influencing the health of the population. That’s often measured in decades. Can we get that down to a sub-decade measure by improving the tools we use? That’s NCATS’s big focus, and they’re demonstrating that focus by targeting their funding toward the new methodologies and technologies.

How are they targeting the funding?

The RFA for renewals for the CTSAs is coming out again soon, but they’re also having RFAs for three new structures. One is called a Recruitment Innovation Center (RIC), one is called a Trial Innovation Center (TIC), and the third is a Collaborative Innovation Network.

So the CTSA awards are the base awards, and they’re going to be reduced on the high end for institutions that had very large awards. Fortunately, we’re already among the smaller centers, so that shouldn’t affect us as much. But they’re likely going to use that reduction to pay for these new awards, and the way you grow your base award is by applying for one or more of these new structured grants.

Can you describe what they’re looking for in terms of RICs, TICs, and Collaborative Innovation Networks?

A RIC is responsible for new or more efficient ways to drive recruitment. Here, for example, through the National Center for Deaf Health Research, we’ve done a lot with the deaf community. So we’re thinking about whether that could be used as a model to recruit and engage with underserved communities, or communities with health disparities.

For the TIC, one example that would apply here is the work that Ray Dorsey has been doing with mobile technology. The mPower app, which is the Apple app that was highlighted recently, allows you to record your medications, record memory activities, there’s a voice activity, a measured gait activity. And that kind of tool is exactly the kind of methodology they’re looking for in terms of clinical trials, because it’s much more efficient than having people come into their research visits once a month.

For something like mPower, you can arrive at estimates of benefits faster. A lot of trials go on for a long period of time and are bigger because of there’s a lot variability of the data. But if you can get more data from fewer people, you can run trials faster, and you’re more efficient because there isn’t so much inter-individual variability. You often hear about certain advancements in research costing X billion dollars, but the reason for that cost is you’re actually amortizing all the failures in addition to the success. For every success, you might have 100 failures or 200 failures. But those 200 failures don’t happen early. They happen over the course of a trial or late in a trial. So one of my hopes is that by getting more accurate data early, you can fail earlier. It seems counterintuitive, but if you can cut off a line of study and save costs on something that’s ultimately going to fail, you can learn faster with more reliability. You can stop that trial and then put your energy into other things.

And then the Collaborative Innovation Network is when three or more CTSA hubs act collaboratively to develop something innovative which will improve the efficiency of trials.

mPower is a great example – what other strengths do we already possess here that could apply to the RFA?

Well what you said is important, because we want to be prepared to respond for this without chasing after something we’re not good at, or that we don’t have strong interest in, or that doesn’t tie in with our strategic aims.

But we already have an emphasis in technology and methodology as demonstrated by our clinical trial methodology pillar. We didn’t know they were going to have RICs and TICs, but we have a pre-existing emphasis on that, so that’s a big advantage.

On community engagement, which fits into the RIC side, we are ahead of the game because of the Center for Community Health and our Community Advisory Group and the efforts we’ve put in to community engagement. And structurally, we’re in a great place to look at what’s happening in the community, because we have a relatively simple and contained health care system, with two major providers, and one regional health database. Most communities aren’t that centralized.

We recently joined a large network called NIPTE where producing drugs or interventional agents can be done from basic synthesis all the way out to packaging and delivering. So that’s an additional strength.

Phil Ng and Adam Tatro have developed a tool that uses i2b2 to extract from the EMR and put into a REDcap database. They just presented that recently and it got a lot of attention because most centers don’t have that, so that could be part of an application, because we’re already developing new biomedical informatics tools to help assist in making trials more efficient.

So I think we’re going to be able to tap a few strategic domains, because they resonate well with what we’ve already been doing and what we want to improve on. And there are more that I haven’t mentioned, but that’s what Martin and Nana and I are thinking about right now: Where we are well placed to apply as a center – a RIC or a TIC – or if there’s something we should apply in to be part of an Collaborative Innovation Network.


Previous directors’ updates:

March 2015 – Martin Zand introduces himself and discusses his interest in informatics and population-based research.
February 2015 – Nana Bennett discusses the CTSI’s Seminar Series on population health.
January 2015 – Harriet Kitzman reflects on her time as a CTSI co-director.
December 2014  – Karl Kieburtz offers his takeaways from the CTSI all-hands retreat.
November 2014 – Nana Bennett speaks to the expansion of the role of the CTSI’s Community Advisory Council.
October 2014 – Harriet Kitzman discusses the science of team science.
September 2014 – Karl Kieburtz talks about why the CTSI is beefing up its informatics team.
August 2014 – Nana Bennett discusses the new Population Health pillar.
July 2014 – Harriet Kitzman offers her takeaways from the Mini Summer Research Institute.
June 2014 – Karl Kieburtz gives an overview of the CTSI’s six pillars.

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