Director’s Update – Applying for a New Collaborative Innovation Award

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors. This month, Martin Zand, M.D., Ph.D. discusses a new funding opportunity that encourages investigators to streamline the process of translating initial discoveries into patient care in collaboration with other CTSA institutions.MartinZandNEW

What is the new Collaborative Innovation Award?

This award was announced by the National Center for Advancing Translational Science (NCATS) last spring. Part of the mission of NCATS is to accelerate clinical and translational research. That means figuring out ways to move research from initial discoveries into patient care. This new award is designed to fund research that removes a barrier to advancing research from one phase to another. For example, a researcher discovers a new potential therapy for cancer. The researcher has tested it in the lab and wants to move it to a preclinical trial. There are many barriers to making that leap. These awards encourage investigators to find innovative ways to minimize those barriers and streamline that process.

What sorts of projects are they hoping to fund?

NCATS is interested in a broad range of research topics. These awards might fund projects aimed at educating people to become research coordinators to combat the current labor shortage in clinical and translational research.  Aiding research volunteer enrollment is also an area of interest. Some examples are: improving clinical trial enrollment by using informatics to help identify people with rare diseases and ensure that the study participants reflect the makeup of the whole community, or using internet-based research consent forms to enroll volunteers in clinical trials.

How do these awards foster collaboration?

There is a very large move at NCATS to encourage scientific team formation and center collaboration across clinical research in this country. Part of the reason is that we are stronger together as research centers than we are individually in terms of being able to enroll large numbers of individuals for research studies. However, one barrier addressed by these awards is that we are sometimes weaker together because we don’t have standardized methods and processes.

That is why NCATS is changing the way it funds research.  There are a number of funding opportunities now that require collaboration between three or more Clinical and Translational Science Award (CTSA) hubs and at least one outside collaborator. The goal is for the CTSA network to really function like an integrated network – not as a bunch of institutions doing their own thing.

 Have we had any success obtaining any of these grants?

These grants were just created last year. The first round of full applications will be reviewed in the fall, and we will know if any were funded in December. So far, we have written letters of collaboration and support for 12 pre-applications and 3 full applications ranging from establishing an education program for regulatory science to assessing the effectiveness of KL2 Mentored Career Development Awards and creating a new individual development program for those awards. These are in partnerships with institutions that span the country. We’re really excited about these applications – they give us a formal way of collaborating with other centers.

Who can apply?

These grants can be submitted by any investigator at an institution that currently has a funded CTSA, like the University of Rochester.  All that an investigator needs is a letter of support from their CTSA.

How can investigators apply?

Applications for Collaborative Innovation Awards can be submitted three times a year and involve a two-step process. The six-page pre-application, called X02, is reviewed like a normal grant. Based on the reviews, the program officer either encourages or discourages you from submitting a full application, or U01.

The U01 is a standard twelve page NIH grant application that includes a budget, a list of personnel, and all of the usual paperwork that goes with a grant. These grants can be $500,000 – $1 million per year for up to 5 year grant period – so, pretty big awards!

What advice do you have for investigators who are interested in applying?

We encourage investigators who are thinking about putting in applications to talk to us early.  The CTSI can help them find partners at other CTSA institutions and help them take full advantage of the available resources for their studies.

Anyone who would like more information about these awards should contact Carrie Dykes, Ph.D., CTSI Research Engagement Specialist, carrie_dykes@urmc.rochester.edu, (585) 275-0736.

 

 

CTSI Director’s Update February 2016: URMC and UB Create a New Collaborative Genomics Pilot Funding Program

genomicsThe University of Rochester Medical Center (URMC) and the SUNY University at Buffalo (UB) released a request for applications last week seeking submissions to a new Collaborative Genomics pilot award program. The goal of this program is to fund projects that will lead to accelerated collaboration between UB and URMC in the area of large-scale, collaborative genomics. In particular, the program is seeking projects that will build on established strengths at both institutions and leverage the collaboration to apply for future NY state opportunities for regional collaborative centers.

This is not the first time that the CTSI has collaborated with the University at Buffalo. UB has been a member of the CTSI’s UNYTE translational research network since its inception in 2006. Also, Tim Murphy, MD, the PI of the Buffalo CTSA, is chair of the CTSI’s External Advisory Committee. When the Buffalo Clinical and Translational Research Center was established in 2015 with a new NCATS Clinical and Translational Science Award (CTSA), Buffalo and Rochester began conversations about how URMC and UB could build new collaborations in translational science and leverage resources and expertise at each institution. The first step in this direction is the new Collaborative Genomics pilot funding program.

The program is designed to fund projects that will make rapid progress over a 12-month period. Projects must use human tissue, primary cells, or primary human microbiome samples. Proposals with a high chance for funding will address one or more of the following areas:
• Collaborative biobanking that includes pilot genomic data generation and analysis
• Analysis of established and unique patient cohorts with existing and extensive clinical data, phenotype data, and existing locally banked biospecimens
• Predictive genomic analysis, especially projects that have existing outcome measures and actual or potential tissue samples for analysis
• Projects that will utilize high performance computational analysis of the resulting genomic data

If you are interested in learning more about the Collaborative Genomics program, please click here to read the complete RFA. Abstracts and initial application cover sheet and cover letter should be submitted by 5 PM, February 29, 2016 in PDF form via e-mail to Tricia_DiQuattro@urmc.rochester.edu.

Director’s Update – October 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors. This month, Karl Kieburtz looks back on the grant-writing process and discusses the advantages to including so many people.KarlKieburtz

First, congratulations on being done!

Thank you! Yes, we’re done, and we’ve submitted the CTSA renewal grant application to NCATS.

This grant involved work from more than 50 people. Why did you feel it was important to include so many of us? I’m guessing that must have made it harder in some ways.

Well, I’ll answer that by giving a little background first, because what we’re actually tasked with here in the CTSI is tricky. First, we’re an institute and we’re supposed to do certain things – we’re supposed to train people, help foster collaborations, get people moving in certain research directions, and so on. And we’re supposed to do that in an organized and structured fashion.

At the same time, we’re supposed to innovate. Innovate is an easy thing to say, but innovation really requires discovery, and discovery is only possible, in my view, when you cease to be enamored with what you know. You can be standing next to someone, seeing the same thing they’re seeing, but they’re looking at it in a different way and so they make a discovery and you don’t. That’s why most innovation organizations are small. It’s a group of guys and gals off somewhere else, disconnected from a mainline organization, fiddling around.

But that perspective – not being enthralled with the rules and trying to forget what we already know – is antithetical to being structured and delivering on things that we say we’re going to deliver on. So that puts us in a difficult position of needing to deliver in an organized way, while also needing to suspend some of the rules.

So that’s tricky. We have an infrastructure grant to provide education, collaborative interaction, and  funding, but it’s tough to innovate infrastructure. I think the only way you can do it is by involving a lot of people and embracing the perspectives of others.

The easiest thing in the world to do is to write down everything you already know. The hardest thing is to listen to what everyone has to say and find a way to express the views of every person. The grant could have been written by a small handful of people just deciding what it is we should do. But, obviously, that’s not what we did.

Did it pay off? Would you do it this way again?

We came up with about a dozen innovative programs beyond what we’re doing now. And these programs weren’t prompted by the grant. They came from people talking to us – at the CTSI retreat, at the Town Hall meeting – about the new things we could try to do.

Ultimately, the actual core text and references was about 190 pages, broken into 10 different sections. Each of those sections had two or three pieces, and each of those pieces had a team of four or five people working on it. That’s what gave us that varied perspective.

If it was just Martin, Nana, and I sitting in a room, that never would have happened. It would have been easier, yes, but not as diverse.

When do you expect to get an answer from NCATS as to whether the CTSI grant will be renewed?

It should be in the next several months. Thanks to all the hard work we did, we think we’re in a good position.

Previous Director’s Updates:

September 2015 Martin Zand discusses the CTSI’s research subject engagement efforts.
August 2015Nana Bennett talks about the renewal grant that the CTSI is pursuing.
July 2015 – Karl Kieburtz seeks feedback in the wake of the CTSI Town Hall meeting.
June 2015 – Martin Zand gives an overview of what will likely be different about the next CTSA renewal application.
May 2015 – Nana Bennett discusses the enhanced role of the Strategic Leadership Group.
April 2015 – Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.
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.
More…

Director’s Update – September 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors. This month, Martin Zand takes a break from the upcoming CTSA grant application to discuss the efforts that the CTSI is taking to expand research subject engagement.MartinZandNEW

People within the CTSI are well aware of what’s been going on here because it’s all we’ve been doing for the past two months – but for the benefit of readers elsewhere, can you give us a quick update on how the renewal grant application is going?

I can say, with much relief, that it’s been submitted to the NIH. More than 50 people have contributed to the grant-writing process, and it came together beautifully.

And… I’m sure you’d love to talk about something other than the grant this month.

Yes, please! I’d actually like to highlight what we’ve been working on in regards to expanding our research subjects engagement program. We’re part of an academic medical center, and so one of our goals is to integrate research into the clinical mission in a substantial and meaningful way. What I mean by that is: We want the people coming to the Medical Center for their care to also be aware of research opportunities, and we are trying to work on different ways of making people aware of research and helping them understand what kind of research opportunities are available. We want to make it easy for them to express interest, be contacted by researchers, enroll in consent to participate.

It’s my understanding that following up after research is also very important. 

Yes, that’s the second part. We want to make sure that people get a real sense of what their contribution has been. So one of the missions of the CTSI is to try and create mechanisms by which investigators inform the people who participated in our research know what their participation has helped to build. People are very interested in that: “Well, what did you find when you took my blood? And did those findings lead to changes?” The other aspect of this would be if their participation also led to new research opportunities, like grants or new projects. When people give their time, it’s important for us to recognize that, and we have a responsibility to let them know what we did with whatever they contributed.

So how are you going about this?

We’re looking at several different routes. In terms of making people aware of research opportunities, we already have a research notification website where people can go and say “I’m interested in being contacted by researchers at URMC.” But we want to make this available on eRecord on MyChart. So one thing we’re exploring  is the ability for a patient to click on a separate tab in MyChart that says “Research studies,” and if an investigator enters a set of criteria, then a research opportunity for that patient might pop up. And if the person checks the box to stay they’re interested, then that notifies the researcher.

Other studies might allow for different types of enrollment. Tim Dye and Karl Kieburtz have both had projects where they used an Amazon service called the Mechanical Turk to do survey research, and that allows you to do survey work across the entire world for very cheap. Ray Dorsey’s mPower app allows people to enroll and consent to research studies with their phone. So it opens up huge doors to what we might do in terms of expanding access to research in nontraditional ways.

We want people to be engaged, interested, and excited about the research happening at UR. It’s what distinguishes us a medical center, and hopefully improves healthcare in our community. Translating that research into medical care is what we do here at the CTSI.


Previous Director’s Updates:
July 2015 – Karl Kieburtz seeks feedback in the wake of the CTSI Town Hall meeting.
June 2015 – Martin Zand gives an overview of what will likely be different about the next CTSA renewal application.
May 2015 – Nana Bennett discusses the enhanced role of the Strategic Leadership Group.
April 2015 – Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.
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.
More…

Director’s Update – August 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors. This month, Nana Bennett discusses the recently-released Program Announcement from the National Center for Advancing Translational Sciences (NCATS) for its Clinical and Translational Science Awards (CTSA) program. The CTSI is pursuing its second five-year renewal.NanaBennett

By now, anyone who works in or around the CTSI probably knows that the NCATS has released the criteria for the new CTSA awards. What can you tell us about them?

Yes, the new RFA is out! And I’m happy to discuss it, but first, a brief bit of background for people who aren’t familiar with the history. URMC was one of the first dozen institutions to receive a CTSA award when the program launched in 2006. These are five year grants that support much of the CTSI. We’ve been renewed once – this is the second time we’re applying for renewal. In terms of total dollars, it’s one of the largest grants at URMC.

The good news is that we thought that the RFA would be similar to the one was that was released last year, and for the most part, it is. The format is a bit different — it’s actually a bit better, a bit more straightforward, than before.  We began preparing based on last year’s so we’re in relatively good shape.

It’s interesting though – taking the longer view, several things have changed and several things are similar to the CTSI as it was years ago. There used to be “key functions,” and then those were eliminated, and now we’re back to what they call “cores,” which are very similar to key functions. But there are also several key themes which are more specific than in the past.

Can you talk about those themes?

Population health is a major one for us. NCATS has been tasked with improving and speeding the impact of research on improving health as a whole, and that’s why our overarching theme here at the CTSI is “from molecules to populations.” We want to help advance basic research – research at the molecular level – and help facilitate its growth and translational potential so that it can be used to improve human health across a population.

In order to span that full spectrum, team science is vital – and that’s another key theme.  Science has reached the point where it’s very difficult for a single investigator to take a discovery all the way from the bench to the bedside to community. In addition, input from community stakeholders is critical to science being responsive to the greatest health challenges facing our nation. Quality and efficiency of research is an important theme – we must show how the URMC can contribute to the national network of CTSAs in ways that speed and improve the conduct of research.

And another key theme is innovative education. Our CTSI educational programs are innovative in content and process. We recently launched a doctorate program called, “Infection and Immunity: From Molecules to Populations” which is specifically designed to train scholars in interdisciplinary research – combining the basic sciences and the population health sciences.  While this is not part of the CTSI, it dovetails with it and is illustrative of our approach.

How many people are working on the renewal grant? What else are we doing to prepare?

The three CTSI co-directors – Karl Kieburtz, Martin Zand, and I – are leading the renewal efforts, but we have more than 50 people involved in the process. We’ve engaged people across the university to ask for feedback and/or contributions to the grant-writing process, and we’ve also asked a group of internal and external experts to review the application before it goes out.

Our deadline is mid-September, so things may be a little frantic for the next 5 or 6 weeks. But we are confident that when we’ve finished the process, we’ll have made a strong case to NCATS for renewal.


Previous Director’s Updates:
July 2015 – Karl Kieburtz seeks feedback in the wake of the CTSI Town Hall meeting.
June 2015 – Martin Zand gives an overview of what will likely be different about the next CTSA renewal application.
May 2015 – Nana Bennett discusses the enhanced role of the Strategic Leadership Group.
April 2015 – Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.
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.
More…

Director’s Update – July 2015

Director’s Update — July 2015

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

Below, Karl Kieburtz circles back to the May 7 CTSI Town Hall Meeting.KarlKieburtz

For the benefit of the people who weren’t able to attend, can you give a quick recap of what was discussed at the CTSI Town Hall Meeting in May?

At the CTSI Town Hall, we asked people “What we do well here?” “What would you like to see more of?” We also asked: “If we went away, what would you miss most about us?”

We hope that by asking that last question, it’ll make people consider the CTSI in a different way. When a good innovation happens, we accommodate to our new circumstances, and the novelty becomes the new normal. You’re recording our conversation on an iPhone. Of course, right? But when that first came out, that was really cool. And when I want to start a manuscript now, I just turn on my app, I dictate to myself, it comes out in text and I email it to myself and edit it. I expect that now. But when I first did that, it was really cool.

So that’s what makes a good innovation. It comes out, gets incorporated into our lives, and then you stop being blown away by the fact that it’s there.

How does this relate to the upcoming renewal?

For the people writing the renewal, part of the effort involves going back over the past 9 years and looking at what’s happened. But because we’re in the midst of it and we take advantage of it, we don’t really stop to think that it wasn’t so long ago that we didn’t have X, Y, or Z. Things that we have now that we’ve grown accustomed to — we want to explicitly call those out and to ask people what they’d miss.

Some of those things people might not realize come from the CTSI. There’s the Junior Faculty Academic Core Curriculum, there’s the Seminar Series, there’s SCORE, pilot funding and incubator funding, the i2b2 to REDCAP tool we developed here, the community advisory council that allows researchers to get input into the community, recruitment capabilities. So to put this question another way, what elements of your day would be different if you didn’t have some of these resources?

And to be clear, we’re not threatening to take anything away, but we just want to know what matters to folks in a way that we might not always see or might not always expect. We develop these programs and resources because we think they are relevant, but those assumptions have to be validated by the people using them. And for the renewal, it’s important that we capture a sense of what things matter to people.

So you tell us. It’s important for us to know what we are doing well and what we need to do better in the future. Please contact ResearchHelp@urmc.rochester.edu and let us know: What would miss most about the CTSI, if it wasn’t here?

[Readers may also provide feedback by visiting the CTSI Suggestion Box to respond to a very brief feedback survey.]


Previous Director’s Updates:
June 2015 – Martin Zand gives an overview of what will likely be different about the next CTSA renewal application.
May 2015 – Nana Bennett discusses the enhanced role of the Strategic Leadership Group.
April 2015 – Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.
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.
More…

Director’s Update – June 2015

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

Below, Martin Zand talks about how the Clinical and Translational Science Awards are changing and how the CTSI is working towards the renewal.MartinZandNEW

Hello Martin. We’ve heard that the CTSA awards are going to be a bit different than they were in the past.

First, a bit of background. The Clinical and Translational Science Institute at the UR was one of the first in the country to be funded 9 years ago, and the grant was renewed 4 years ago. Every 5 years we have to compete with other current centers, and new center proposals, to renew our NIH funding through the National Center for Advancing Translational Sciences (NCATS). Our grant is coming up for its third competitive renewal this year.

What can you tell us about the changes, and why are they happening?

In the past, the awards were basically individual center awards, where a center puts out a plan for what it was going to do locally that was within the description and requirements of the grant requirements from NIH. Those activities included growing and providing services to support translational research, workforce training, pilot programs to help young investigators, and so on. In the past, there wasn’t much emphasis on collaborations and networking between the 62 centers funded across the country. But over the last two years, there’s been a dramatic shift. The expectation over the next funding period will be that all the CTSAs across the country will collaborate with each other, and create a cohesive nationwide research network. The goal of this is to accelerate clinical and translational research across the country.

One of the things that has motivated the National Center for Advancing Translational Science (NCATS) is that somewhere close to 30 percent of all NIH sponsored clinical trials are never completed. It’s not that they finished and weren’t published, they were just never even finished. So that’s a startling and very worrisome figure. We’re talking about hundreds of millions, if not a few billion dollars, that went into funding studies where, in the end, no usable results come out. Why does this happen?  A small portion of the answer turns out to be scientific: the problem was different than people thought, or they had to close down a trial because of early findings.

But that doesn’t account for all of them.

Unfortunately, no. Many studies never finish for structural reasons. And by that, I mean there are vast differences in how each research center handles the trial. All the centers currently have separate institutional review boards, contracting policies, cost structures. Some centers would negotiate for more funding because expenses were higher there than elsewhere. So if you’ve got a dozen institutions that agree conduct a clinical trial, you have to negotiate a dozen modifications to the consent form, which the other centers all then have to agree to. Then, you might need a dozen different contracts to pay for the trial, one with each center. Then you have the usual operational issues of enrollment, standardization of record keeping, and so on.  So, you can imagine that this process can take years. So, many studies didn’t even get started until the second or third year, and then funding finishes in year five.

What about the studies that actually finish?

Of the studies that actually finished, only about a 60-70 percent of them are published. The reasons for that are a little harder to ferret out. Negative studies often do not get published, and some end up having design flaws that become apparent in the statistical analysis after they were finished. But whatever the reason, if you’ve got scientific ideas you’re trying to take from the bench to the bedside, and in a large percentage of cases it doesn’t happen, then you should fix it. So Congress has been putting pressure on the National Institutes of Health, as they should. And NIH has tasked NCATS with creating a viable clinical trials network based on the CTSA centers. Overall, this is a really positive direction, and we all hope it leads to better, faster, and more scientifically insightful clinical trials.

What else has changed?

The other big change in the CTSA renewal is an increasing emphasis on team science. Scientific investigation has gotten very complex, with all the genomics, proteomics and other -omics technologies. Our ability to generate very, very large amounts of data has far outstripped our ability to analyze it. It’s really hard for any one investigator to do it all. The days when you could run your lab independently, without collaborators, and do all the statistics on an Excel spreadsheet or small statistical program are gone. Now you really need informatics databases, more sophisticated statistical collaborators, technical experts in RNA sequencing, and many other experts in complex methods and data analysis techniques that didn’t exist two decades ago..

Isaac Newton said “If I have seen further than others, it is by standing on the shoulders of giants.” Today, there continues to be an increasing recognition that no person can be doing discovery in isolation. So the nature of how we train people to be clinical researchers and scientists also has to change. Recognizing this, the coming CTSI renewal has a much greater emphasis on educating collaborative teams and fostering collaboration. These skills help Ph.D. researchers and clinicians collaborate and benefit from each other’s expertise, insights, and skills to take something from the bench to the bedside. So NCATS is placing less of an emphasis on funding individual projects and more of an emphasis on training scientists to work in teams.

If there’s less emphasis on individual projects, what will happen to the pilot program?

The pilot programs are an integral part of what the CTSI does, and will continue to be supported. You’re right that less of the funding will come from NCATS than in the past. But we are very fortunate that the Medical Center and the School for Medicine and Dentistry have recognized the importance of these programs, and provide other funds to help us keep them alive. In addition, the co-directors of the CTSI, Karl and Nana and I, are actively exploring ways of invigorating the funding program, so you might see more funding initiatives that ask for matching funds from divisions or departments, industry, and University wide partnerships.

I think one message for investigators is that we are all going to need to be more entrepreneurial. The more creative you can be in terms of finding matching funding and partnering with others, the greater your chances of success. A second message is to collaborate. Fortunately, the UR is a very collaborative institution, and it’s easy to find research partners. That’s also one of the roles of the CTSI – connecting people with common research interests.

Anything else you wanted to mention?

Well, writing the renewal itself is a team effort!  We have an incredible staff here at the CTSI, and there are individuals throughout the institution that are very dedicated to working on the renewal. We have over 40 authors right now for the renewal project. So it’s an industrial-sized undertaking. I think that all of us in leadership know that while it’s going to be a lot of work, I have no doubt that it’ll be done to an extraordinarily high level.


Previous Director’s Updates:

May 2015 – Nana Bennett discusses the enhanced role of the Strategic Leadership Group.
April 2015 – Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.
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.