Introduction & Welcome

Welcome to CTSInsider, the newsletter of the Clinical & Translational Science Institute of Southeast Wisconsin! Through this quarterly newsletter, we hope to share more information about:

• what the CTSI has to offer you and those engaging in clinical and translational research
• the CTSI and the national CTSA network
• why the CTSI exists
• exciting opportunities throughout the year related to clinical and translational research and education

In this issue you will find a brief overview of some of our 2016 accomplishments, CTSI news and announcements, and highlights of services we have available to support you and your research.

CTSI & You

CTSI is here to serve you! CTSI offers a variety of resources and services to augment the myriad of research infrastructure options available to research teams across CTSI partner institutions.

In 2016, 866 investigators and research personnel benefited from CTSI services and resources.

While these individuals come from across all of our partner institutions, the majority (79%) are from the Medical College of Wisconsin, followed by the Children’s Hospital of Wisconsin (5%), the University of Wisconsin-Milwaukee (4.6%), and Froedtert (4.2%). Our most frequently used service in 2016 was our Clinical and Research Data warehouse, which provides investigative teams access to clinical data from the Froedtert and Children’s Hospital electronic health record systems. Teams are able to query clinical information through i2B2, which stands for “Informatics for Integrating Biology and the Bedside”.

In 2016, CTSI also supported two collaborative research workshops which brought together a diverse set of stakeholders together around the topics of PTSD and veteran’s health and patient-centered and community-engaged clinical trials. The primary objective of those Nucleating Workshops is to develop and facilitate multidisciplinary team research collaborations targeting specific health topics identified by the community. In addition, workshops aim to involve a more diverse group of stakeholders, thus expanding team diversity. Members of the community, patients, as well as other appropriate participants (e.g. social workers, teachers, public health and teaching professionals, etc.) are invited to participate. In the last quarter of 2016, through a request for suggestions, we received seven collaborative research proposals ranging in topics from nutrition and motivation in Milwaukee public school freshmen, alternative treatments for epilepsy, violence prevention strategies, and pelvic organ prolapse in women. We are excited to support these collaborative research teams and see how they develop further in 2017!

In 2016, we also supported 165 of your active research projects through our pilot & collaborative grants, our KL2 Mentored Career Development program, services through our Adult Translational Research Unit and Clinical Trials Office. Throughout the year we hope to highlight some of your work and the research we are supporting through our infrastructure.

About CTSI

Did you know that the CTSI is part of a national consortium of US medical schools, less than half of which have received a CTSA award since the program’s inception in 2006?

Our CTSI partners are comprised of the BloodCenter of Wisconsin, Children’s Hospital of Wisconsin, Milwaukee VA Medical Center, Froedtert Hospital, Marquette University, MCW, Milwaukee School of Engineering, and the University of Wisconsin – Milwaukee. There are currently 64 CTSA awards nationwide. The national CTSA award is a research infrastructure grant, meant to supplement existing resources available for research at each of the partnering institutions. The collaborations and partnerships fostered through the CTSI already have paid off in innovation and translation of new technologies and advancements, as together we work to advance health through research and discovery! Learn more>

News & Announcements For You

2017 CTSI Science Cafés

Come hear about health issues that matter to you.  Share your experiences and get the chance to ask our experts for advice.

Please join the CTSI and the St. Ann Center for Intergenerational Care for this year’s Science Cafés. The purpose of the Science Café program is to engage with the community and translational scientists in an informal setting and discuss, informally, current scientific and medical issues impacting our culture and society. This year’s topics range from Diabetes to Opioid Abuse. Science Cafés occur on the fourth Tuesday of every month at St. Ann’s. Mark your calendar today!

Funding Opportunity: GPC 2017 Inter-Institutional Pilot Program RFP April 17, 2017

The Greater Plains Collaborative (GPC) is a network of twelve leading medical centers in eight states committed to a shared vision of improving healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination.

The purpose of the pilot program is to provide modest support that will allow an investigator the opportunity to develop sufficient preliminary data utilizing the GPC’s data infrastructure as a basis for a larger application for independent research support for the investigator and the network. Read the full RFP.

Introducing CTSI Academy: Training in Practical Aspects of Translational Research

CTSI is excited to announce the launch of CTSI Academy, a one-stop shop for training in the practical aspects of translational research. Fundamental to our success is the availability of a well-trained translational workforce. An important segment of this workforce includes the non-investigator personnel that assist in various capacities in a successful research program. CTSI Academy will offer a specific focus on training and education for this segment of research personnel, in addition to offering important aspects of research training to PIs. Our theme is “Advancing Health through Education in Research and Discovery.”

The Academy will aim to transform training and education for current and future translationists by narrowing the gaps in education and training on the practical aspects for the conduct of research in collaboration with the MCW Office of Research and our partner institutions.

This past month we kicked off a NEW Boot Camp series aimed at clinical research management and conduct and continued our Oncore Lunch & Learn Series, with session 5 on April 11th. Stay tuned for future announcements on CTSI Academy in the coming months.

CTSI Discovery Radio ~ Highlighting Your Research

Hear interviews and information about what scientists across southeastern Wisconsin are “discovering” in their labs and clinics.

Discovery Radio is meant to provide you with a look behind the curtain of what is happening to accelerate discoveries to improve the health of our community sometimes years before you would ever hear about it anywhere else. Discovery Radio introduces you to new and novel discoveries and the researchers behind them. It will change the way you think about your health and well-being in Wisconsin. Last month’s show included a special report on a research collaboration to battle our community’s opioid abuse crisis. Listen or follow CTSI on Soundcloud to learn more. 

19^th Annual HHS SBIR/STTR Conference: In The Heartland of BioHealth Innovation

November 7 -November 9 2017
Hilton Milwaukee City Center

Save the Date! Milwaukee, WI and the CTSI of Southeast Wisconsin were among several cities who submitted to host this annual national conference and we won! Our team, which included individuals from CTSI partner institutions, led by MCW’s Kalpa Vithalani, delivered a bid package which not only addressed HHS’s concerns, was to-the-point, succinct and in the words of the Assistant Program Manager of the NIH SBIR/STTR Program Office “ rose head and shoulders above the other applications.” Mark your calendars for November 7 – November 9 2017 at the Hilton Milwaukee City Center. More details, including registration will be available early May 2017. Download the event flyer.

Conference Goals
This national conference helps small businesses in the life science sector learn about over $920 million dollars of annual HHS funding, one of the largest sources of early-stage capital for technology commercialization in the United States. These programs allow US-owned small businesses to forge academic partnerships and build businesses to engage in research and development that has a strong potential to deliver products and services to improve the health of Americans. It is the cornerstone of HHS’s congressionally mandated outreach efforts. Attendees discover how to successfully submit an application and learn about approaching partners and investors, the types of HHS assistance programs offered to awardees, and have the chance to discuss specific questions with HHS SBIR/STTR subject-matter experts.

Intended Audience

•  Small businesses wanting to develop innovative technology products
•  Highly motivated small business entrepreneurs and researchers
•  Small businesses interested in new NIH SBIR/STTR initiatives and program changes
• University researchers interested in partnering with small businesses on collaborative R&D projects
•  University researchers interested in starting their own companies
• Large companies interested in developing strategic alliances with successful SBIR/STTR awardees
•  Organizations and consultants providing support to interested SBIR/STTR applicants

CTSI’s 500 Stars Initiative 

The CTSI 500 Stars Initiative is a ten-year, comprehensive, multi-institutional, educational & workforce development plan focused on replenishing, while increasing diversity (under-represented minorities) in the translational science workforce. The Initiative’s activities run throughout the academic year and works directly with well-established regional partners in an effort to support and move the translational workforce along existing ‘regional’ pipeline programs.

Our Vision is to enrich the southeast Wisconsin translational research workforce through promoting inclusion and diversity.

Our Mission is to provide training and educational opportunities to students of diversity in high school, undergraduate, and graduate programs who are looking for careers in the clinical and translational science space. Our Goal is to enroll 500 students over 10 years into the CTSI 500 Stars initiative. Each of our 500 Stars have the ability to enter the initiative pipeline at any stage. Student families are critical to career achievement and success; as such the program is a combined student/family enabling endeavor.

CTSI Summer Internship Program
The CTSI Summer Internship Program (SIP) offers direct, hands-on, professional experiences in clinical and translational science settings at CTSI partner and collaborator sites, as well as providing additional educational development through films and research forum series, lectures, seminars, field trips and/or events. Program leadership work with students and Faculty mentors in determining placement in our SMART (Students Modeling a Research Topic) Teams and Advanced SMART Team sites, research labs, and clinical/translational/administrative department sites at MCW/CTSI and our partner institutions, as well as in the community, to participate in research (and other related) projects in clinical and translational science. Depending on the placement site, as well as the project, the summer experience is between 6-8 weeks. Each student is paired with an accomplished mentor and their teams to complete the project over the internship period.

CTSI’s Regional Community Engagement Network Initiative 

Advancing Health through trans-disciplinary Community Engagement
The CTSI is expanding Community Engagement activities, led by Dr. Syed Ahmed, CTSI’s director of community engagement, to develop a Regional Community Engagement Network Initiative (RCENI) “to achieve together what we cannot achieve alone”. Constituents of the initiative represent the CTSI partners including Marquette University, University of Wisconsin, Milwaukee School of Engineering, UWM’s Zilber School of Public Health, and the Blood Center. The rational for this initiative is to propose and develop ideas on how we, in partnership with community members and community-based organizations, could cross connect to propose concrete strategies, and leverage each other’s strengths towards building a regional network for community engagement activities.

The objectives of the Initiative are to:

1. To establish deeper connections between partners
2. Enhance capacities
3. Advanced education and experience
4. Discovery and dissemination, with the overarching goal of ‘advancing health through trans-disciplinary, community-engaged research and discovery.

A Steering Committee for the RCENI (representative of all partners) has been formed and are currently engaging in conversations and group sessions around identification of partner assets, priority areas of focus, and strategic planning.

National News and Announcements

NIH achieves milestone to accelerate multisite clinical studies

The National Institutes of Health is leading policy and programmatic initiatives to streamline this overly cumbersome process. NIH’s National Center for Advancing Translational Sciences (NCATS) announced today that all Clinical and Translational Science Awards (CTSA) Program sites have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement. This agreement — which now includes a total of more than 150 top medical research institutions — will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference.

The SMART IRB authorization agreement serves as a model to help investigators adhere to the NIH’s policy on single IRB use for multisite studies. This policy was designed to improve IRB efficiencies while ensuring the protection of research participants so that research can proceed expeditiously.

The authorization agreement effort was led by Harvard Catalyst, University of Wisconsin-Madison Institute for Clinical and Translational Research, and Dartmouth Synergy. Through these institutions, a team of NCATS-supported SMART IRB ambassadors facilitated and provided critical guidance and support to assist institutions in joining and implementing the SMART IRB authorization agreement.

“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”

In addition, the SMART IRB authorization agreement will provide the foundation for NCATS’ Trial Innovation Network central IRBs. The Trial Innovation Network is a collaborative CTSA Program initiative designed to address critical roadblocks in clinical research, and to optimize and streamline the clinical trial and studies process.

Next steps for the NCATS SMART IRB Platform include the development of education, training and harmonization of best practices for a single IRB review. Learn more at https://ncats.nih.gov/expertise/clinical/smartirb and https://smartirb.org (link is external).

Read the NIH News Release from March 23 2017: https://www.nih.gov/news-events/news-releases/nih-achieves-milestone-accelerate-multisite-clinical-studies 

Apply Today for the 2017 Grant Writers Coaching Group for NIH Awards

The AAMC is accepting applications for the 2017 Grant Writers Coaching Group for NIH Awards designed for faculty who are actively working on a K or R NIH grant proposal. The focus is to increase diversity in medicine and science with an emphasis on faculty who are underrepresented in medicine (URM).

This one-day intensive workshop offers hands-on guidance and cultivates development through peer review sessions created specifically to strengthen a proposal. The program provides individual coaching, 2-3 months bi-weekly virtual group meetings, and on-going support and discussion. Applications for the 2017 Grant Writers Coaching Group for NIH Awards are due by June 21, 2017 at 11:59 PM, EST. Additional information and guidelines, as well as the link to apply, are available here.

Audience: Priority consideration will be given to URM faculty, but all faculty regardless of racial ethnicity are encouraged to apply.
Registration Process: Once accepted to the program, a registration fee of $1,000 will automatically be processed on the credit card provided during application.

Questions?
Program Information: Tai Conley
Conference Logistics: Shayna Kritz
Conference Registration: Debra K. Hollins

CTSA Program Good Clinical Practice Standards Published

To improve the translational science process, clinical trial personnel must be qualified and have the necessary skills to implement safe and efficient studies. To help meet this goal, Clinical and Translational Science Awards (CTSA) Program hub investigators collaborated to establish ethical and scientific quality standards and competencies — called good clinical practice (GCP) — for the design, conduct, recording and reporting of clinical research involving human subjects.

GCP is composed of three phases, which the investigators described in three recent papers in the Journal of Clinical and Translational Science. In the first phase, the investigators developed a consensus across the CTSA Program national network about training guidelines and standards in the implementation of clinical trials. The second phase focused on developing competencies and minimum qualifications for a training curriculum for researchers involved in clinical studies. During the third phase, the investigators established best practices for conducting social and behavioral research, with the goal of creating learning modules. Hub personnel are currently testing the effectiveness of the GCP training standards at their respective institutions.

• View the article published online on Jan. 13, 2017: Education and training of clinical and translational study investigators and research coordinators: A competency-based approach(link is external)
• View the article published online on Jan. 13, 2017: Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators(link is external)
• View the article published online on Feb. 6, 2017: Best practices in social and behavioral research: report from the Enhancing Clinical Research Professional’s Training and Qualifications project

CTSI At Your Service

CTSI offers more than 20 different services and resources all aimed at supporting you and your clinical and translational research. You can learn more about our services and resources here. Below are two new services available to you via the Clinical Trials Office.

Oncore Clinical Trials Management Software

Looking for a new tool to help manage your clinical trials? OnCore is the Clinical Trial Management Software (CTMS) utilized by the Medical College of Wisconsin and is available to all departments for their study management needs. Contact us for a demo today.

TriNetX

TriNetX is a federated clinical data network of providers, pharmaceutical companies and contract research organizations (CROs) used to enhance clinical trial design and accelerate trial site and patient recruitment.  The TriNetX Network can facilitate participation in new industry-sponsored clinical trials while improving the design and subject accrual for clinical studies. TriNetX also supports deeper insights into a patient cohort to enhance your investigators’ research programs, and enables them to collaborate with peers and other member institutions. Sign up to receive notifications in your inbox today.

Investigator’s Corner: You & CTSI Advancing Research & Discovery

KL2 Mentored Career Development Award

The CTSI of Southeast Wisconsin congratulates Tammy Lyn Kindel, MD, PhD, recipient of the 2017 NIH Mentored Career Development Award. The award provides training opportunities for junior faculty working in clinical and translational research to become independent investigators.

Dr. Kindel is an assistant professor of surgery in the division of general surgery at the Medical College of Wisconsin and Froedtert Lutheran Memorial Hospital. She received her medical training at the Ohio State University and completed general surgery residency in 2013 at Northwestern Memorial Hospital/Feinberg School of Medicine in Chicago.  Additionally, she completed a fellowship in Minimally Invasive and Bariatric Surgery at the University of Nebraska in Omaha.  Dr. Kindel earned a PhD in Pathobiology and Molecular Medicine. Her translational research interests are in the hormonal changes induced after bariatric surgery that are responsible for the improvement in metabolic disease post-operatively.

Please join us in congratulating Dr. Kindel!

Clinical Research Scholar Receives NIH KO8 Award

Meredith Adams, MD, MS, assistant professor of anesthesiology and CTSI Clinical Research Scholar, has been awarded a four-year, $737,492 Mentored Clinical Scientist Research Development Award (K08) from the National Institute of Biomedical Imaging and Bioengineering. The goal of the award, titled, “Identifying opioid response phenotypes in low back pain electronic health data,” is to accelerate pain medicine research by translating clinical experiences into discrete and analyzable data, specifically, examining opioid response patterns for patients with low back pain in the electronic health record.

This project will adapt and apply natural language processing, data standardization, mining, and analysis tools to specifically model opioid response phenotypes of patients with lower back pain to characterize pain intensity, functional status and pain interference with activity.

CTSI Staff & Faculty: At Work for You

Each newsletter we will highlight staff and faculty working to support you and your research. Sonia is a program manager with the CTSI. Sonia wears several hats and manages multiple roles including:

• Regulatory Navigator which can help guide, track, trouble shoot and monitor your IRB application.
• Pre-review service will review your IRB application and all other documents prior to submission, this service helps decrease the time required to attain IRB approval.
• Recruitment coordinator to help investigators develop and implement strategies on how to recruit subjects for their studies.
• Research Participant Advocate (RPA) which is available to assist with protecting the safety and confidentiality of research participants who volunteer for clinical studies. The RPA is a resource for potential research volunteers and a liaison and consultant to research teams.

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