SCTRSouth Carolina Clinical & Translational Research Institute

2009-2010 Annual Report

Biomedical InformaticsIain Sanderson, BM BCh — Program DirectorJihad Obeid, MD — Associate Director

Clinical & Translational Research Center (CTRC)Gary Gilkeson, MD — Program DirectorLindsay DeVane, PharmD — Associate Dir & Lab DirectorPatrick Flume, MD — Associate DirectorJim Oates, MD — Chair, CTRC Advisory CommitteeSusan Sonne, PharmD — Operations DirectorCarol Wagner, MD — Associate Director

Community Engagement & ResearchMarilyn Laken, PhD, RN — Program DirectorSara Wilcox, PhD — Associate Director

Evaluation & TrackingDavid Murday, PhD — Program Director

Novel Methodologies Robert Adams, MD, MS — Program Director

Pilot ProjectsPerry Halushka, PhD, MD — Program DirectorAnthony Alberg, PhD, MPH — Associate Director

SCTR LeadershipKathleen Brady, MD, PhD SCTR Principal InvestigatorPerry Halushka, PhD, MD Co-Principal InvestigatorRandal Davis Project DirectorRoyce Sampson MSN, RN, CRA Finance & Administration Director

Regulatory Knowledge & Support Robert Malcolm, MD — Program DirectorSusan Sonne, PharmD — Associate Director

Design, Biostatistics, Epidemiology, & Clinical Research EthicsPaul Nietert, PhD — Program DirectorProgram DirectorRobert Sade, MD — Clinical Research Ethics DirectorClinical Research Ethics Director

SUCCESS Center Royce Sampson, MSN, RN, CRA — Royce Sampson, MSN, RN, CRA — DirectorStephanie Gentilin, MA, CCRA — Stephanie Gentilin, MA, CCRA — Associate Director

Training, Education & Career Development Thomas Hulsey, ScD — Thomas Hulsey, ScD — Program Director Marc Chimowitz, MB ChB — Marc Chimowitz, MB ChB — KL2 & Mentoring Director

Translational Technologies & ResourcesCharles Smith, PhD — Program DirectorJohn Arthur, MD, PhD — Associate DirectorWilliam Hood Jr, JD, MS — Associate Director

External Advisory Board

John Raymond, MD — Chair, MUSC Provost Vice Admiral Albert Baciocco Jr, USN (Ret) —

MUSC Foundation for Research DevelopmentRebecca Bullard-Dillard, PhD — Claflin UniversityGarrett FitzGerald, MD — University of PennsylvaniaJay Moskowitz, PhD — Health Sciences South CarolinaHarris Pastides, PhD — University of South CarolinaRoger Stevenson, MD — Greenwood Genetic CenterVicki Young, PhD — South Carolina Primary Care Assoc.

Community Advisory Board

Jonathan Butzon — Charleston Education NetworkLeonard Davis, DDS —

Hollings Cancer Center Health Disparities BoardShauna Hicks — DHEC Office of Minority HealthTony Johnson, PhD — The Citadel School of EducationRev. Jeanette Jordan, MS, RD, CDE —

J & J Health ConsultantsOtha Meadows — Trident Urban LeagueBrenda Nelson, PhD — Charleston County School DistrictElsa Pardo — SC Hispanic OutreachCora Plass, MSW — DHEC Healthy Aging ProgramCarrie Whipper — Carrie Whipper — Heart & SoulCol. George Williams — Col. George Williams — The Citadel School of Education

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Pilot Projects

Evaluation &Tracking

Biomedical Informatics

Clinical & Translational Research Center (CTRC)

Regulatory Knowledge & Support

Design, Biostatistics, Epidemiology & Ethics

Training, Education & Career Development

Novel Methodologies

Translational Technologies & Resources

BASIC RESEARCH

CLINICAL RESEARCH

COMMUNITY ENGAGEMENT

Community Engagement & Research

SUCCESS CENTER:The “Front Door” to the SCTR Institute

A Note From Our Principal Investigator

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The South Carolina Clinical & Translational Research Institute is the result of collaborative efforts of clinicians, researchers, and educators across the state of South Carolina, all with the shared vision of improving the health of the state’s citizens shared vision of improving the health of the state’s citizens and beyond. SCTR has provided robust research support, and beyond. SCTR has provided robust research support, better training, and expedited development of new better training, and expedited development of new treatment.

This year alone, SCTR provided assistance and services to principal investigators representing $110 million in grant funding. We supported 88 separate grants in 65 distinct scientific specialty areas. Our work has spread beyond the six MUSC Colleges to include investigators at Clemson University, Greenwood Genetic Center, University of South Carolina, VA Medical Center, and members of the community.

Upon completion of our inaugural year as the SCTR Institute and part of national CTSA Consortium, I can say without hesitation that I’m extremely pleased with the infrastructure we’ve developed and the achievements we’ve made in such a small timeframe.

To date, the SCTR SUCCESS Center has provided over 1,500 consultations, and with Health Sciences South Carolina, we have established an academic home for Biomedical Informatics in South Carolina. We are sure that the Informatics in South Carolina. We are sure that the foundation we have created this year will serve as a foundation we have created this year will serve as a springboard for the future, accelerating our discoveries into springboard for the future, accelerating our discoveries into new patient treatments.

Our gratitude is extended to our affiliate institutions, our leadership, and the researchers who have chosen to partner with us — knowing that together, we can make healthcare better for all South Carolinians and beyond.

Sincerely,

Kathleen Brady, MD, PhD SCTR Principal Investigator

OUR PARTNERS

Universities1. Medical University of South Carolina2. Claflin University3. Clemson University (CU)4. South Carolina State University5. University of South Carolina (USC)

Greenwood Genetic CenterHealth Sciences South Carolina

Ralph H. Johnson VA Medical Center

Regional AHEC Centers

SC Research Authority

1

42

5

3

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SCTR Institute: 2009-2010 Achievements

$111,676,295 in grant funding affected by SCTR services

$730,000 Pilot Project awards to SCTR faculty

52,000 MUSCHero.org website hits each month

1,802 patients enrolled at the Clinical & Translational Research Centerpatients enrolled at the Clinical & Translational Research Center

403 individual requests for services processed

128 principal investigator collaborations

88 grants supported by SCTR services

65 distinct scientific specialty areas impacteddistinct scientific specialty areas impacted

14 KL2 Scholars and TL1 Trainees

1 Distinguished University Professor

HIGHLIGHTS

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Working together, CoEE, HSSC, and SCTR will transform the conduct of clinical and translational research in South Carolina and beyond. This enterprise has been transforming research at the state’s universities while significantly strengthening the translational research infrastructure.

Dr. Iain Sanderson, CoEE Endowed Chair in Medical Informatics at MUSC, is leading a plan for shared informatics resources between SCTR and HSSC, a model of this breakthrough collaboration. A current example of this powerful collaboration is the South Carolina Integrated Platform for Research (SCIPR). It is intended that SCIPR will be the foundation of the research informatics infrastructure for all of HSSC’s collaborative institutions, including SCTR. This integration will greatly enhance the effectiveness of multi-site clinical trials throughout South Carolina, a shared goal for all involved.

In addition, HSSC has been the driving force behind the SC Light Rail High Speed network and the recently funded FCC Rural Health Network, both of which will enhance the opportunity for statewide clinical trials.

Working Together to Transform Research

The SC Centers of Economic Excellence Program, Health Sciences South Carolina, and South Carolina Clinical & Translational Research Institute have much to gain by collaborating on extraordinary research opportunities.

BIOMEDICAL INFORMATICS

— Implemented REDCap data capture software; 26 projects produced, an additional 35 under production; and 175 surveys have been developed.

— Developed software solutions for SCTR applications: MUSC Approval Plans for Research Tool (MAP-R), Research Toolkit, and Clinical Trials Registry.

— Implemented ClickCommerce, the consolidated eIRB system, across multiple institutions including MUSC, Greenville Hospital System, Spartanburg Regional Hospital System, USC, and Palmetto Health.

— Established the Computational Biology & High Performance Computing Core to provide data analysis services.

TRANSLATIONAL TECHNOLOGIES

— The Biotechnology Interest Group (BIG) has been established.

— The SCTR Center for Business Development has been initiated; SCTR Translational Assistance and Review (STAR) Consults and several local experts in biotechnology development have been recruited to advise on commercialization activities. Initial successes include consulting on 4 IND applications, 5 patent filings, and 2 invention disclosure statements.

— The SCTR Biorepository is now located adjacent to the CTRC facilities. Staff are working with the MUSC Hospital Authority to re-design the clinical Consent-to-Treat document to include the retention of discarded material for use in research.

Dr. Robert Adams

CoEE Endowed Chair in Stroke SCTR Novel Methodologies Director

Dr. Marc Chimowitz

CoEE Endowed Chair in StrokeSCTR KL2 & Mentoring Director

Dr. Jihad Obeid

CoEE Endowed Chair in Biomedical InformaticsSCTR Biomedical Informatics Associate Director

Dr. Iain Sanderson

CoEE Endowed Chair in Medical InformaticsSCTR Biomedical Informatics Director

HIGHLIGHTS

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— The SUCCESS Center has received over 1500 individual research support requests since inception.

— 403 support requests have been processed in the first CTSA reporting period encompassing only 8 months.

— SPARK, the online service request module for all SCTR services, has been implemented.

— The Research Toolkit has been launched, receiving an average of 36,800 hits per month, as well as requests from other CTSA institutions for duplication.

— The SUCCESS Advisory Board, comprised of representatives from research offices and colleges across campus, meets quarterly to provide

Community Request (52)

Grant & Budget (25)

Recruitment (57)

Navigation (101)

Regulatory (168)

SUCCESS CENTER & REGULATORY KNOWLEDGE

recommendations to guide the development of SUCCESS Center services and to promote coordinated collaboration with other research support offices.

— A weekly email announcement has been launched to promote research-oriented activities. Likewise, a calendar has been created to record institution-wide activities related to research initiatives.

— SCTR has supported research in all six MUSC Colleges (Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing, and Pharmacy), the Department of Library Science and Informatics, community organizations, and institutions, including Clemson, Greenwood Genetic Center, USC, and VA Medical Center.

The SUCCESS CenterThe Support Center for Clinical and Translational Science (SUCCESS) is the universally accessible, consolidated entry point for assistance, resources, and research navigation support spanning the entire spectrum from inception of ideas through technology transfer and dissemination of best practice models.

SUCCESS links investigators and research team members to SCTR and other institutional services cores and programs. SUCCESS directly provides research navigation assistance, regulatory and recruitment consultation, grant forms assistance, and budget development consultation. Staff members work diligently to stay abreast of potential emergent issues in the research environment within our consortium. An intensive competency-based orientation program, including protection of human subjects training and Good Clinical Practice, is part of staff’s ongoing training. This adaptive training ensures that all staff members are well informed of resources and services and maintain up-to-date knowledge of local, state, and federal rules and regulations.

SCTR SUCCESS Center Requests for Consultations

42%

25%

14%

6%

13%

“ The first time I decided to use the SUCCESS “ The first time I decided to use the SUCCESS Center was because I did not know who else to Center was because I did not know who else to ask. After that experience, there was no doubt ask. After that experience, there was no doubt that they would either have the answer or find that they would either have the answer or find the person who knew a bit about the the person who knew a bit about the question. question.

I think that using the SUCCESS Center greatly I think that using the SUCCESS Center greatly assisted in our communication with the FDA and our IND application. “

Sue Reed, DDS, DrPH Associate Professor College of Dental Medicine

PROVIDING ANSWERS:

MAP-R (MUSC Approval Plan for Research)This tool is an algorithm-driven program that helps users identify those regulatory and institutional approvals, applications, and forms required to begin a research study. MAP-R provides a comprehensive list of applications and links tailored for specific research studies. It compiles data into a concise chart and generates a customized action plan. This collaborative project was created by SCTR, the Office of the Associate Provost for Research, and the Office of the Chief Information Officer.

REDCap (Research Electronic Data Capture)Developed by Vanderbilt University as part of a collaborative international consortium, this secure, web-based data management system supports data capture and management for research studies. Utilizing REDCap’s stream-lined process for rapidly developing databases, researchers may create and design databases with 1) the online method from any web browser using the Online Form Editor; and/or 2) the offline method which can be later uploaded into REDCap.

Clinical Trials RegistryMUSC’s Clinical Trials Registry is a searchable listing of MUSC’s Clinical Trials Registry is a searchable listing of active Institutional Review Board-approved research active Institutional Review Board-approved research studies available to the public. Investigators are studies available to the public. Investigators are encouraged to add their own research studies and study encouraged to add their own research studies and study contact information. Those interested can contact study personnel to obtain more information about the study or to express interest in enrollment. SCTR started the MUSC Hero campaign specifically to promote this tool to the general public and raise awareness of clinical research participation.

ResearchMatch.orgResearchMatch is a national research volunteer registry started by Vanderbilt University that aims to connect volunteers with appropriate research studies. Volunteers log-in, create a profile, and fill in their contact and basic health information. Once registered, the volunteer will be contacted by ResearchMatch via email if there is a study for which the volunteer may qualify.

Research ToolkitSpecific to MUSC researchers, this instructional guide offers information related to the research process. It was derived from a collaboration of input from MUSC research administration offices, researchers and research administrators, and the Office of the Associate Provost for Research. The Toolkit addresses the steps involved with obtaining funding; submitting proposals; implementing, conducting, and closing studies; and disseminating outcomes. It also includes links to institutional, state, and federal resources and regulations.

SCTR Programs Application & Request Kiosk (SPARK) SPARK is the central online mechanism for requesting SPARK is the central online mechanism for requesting SCTR services and proposal pricing for all of the SCTR SCTR services and proposal pricing for all of the SCTR programs, including the SUCCESS Center, Biomedical programs, including the SUCCESS Center, Biomedical Informatics Program, Biostatistical & Ethics Program, Clinical & Translational Research Center, Community Engagement Program, Novel Methods & Translational Technologies Programs, Pilot Projects Program, and Education & Career Development Programs.

Online Research Tools (http://sctr.musc.edu)

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— 99 protocols have been administered in the CTRC since its integration into SCTR. 66 investigators from 26 different specialties, ranging from pediatrics and neonatology to substance abuse, rheumatology, and cancer vaccine development have taken advantage of the facility and its services.

— CTRC works to support studies funded by various NIH institutes and centers, such as NIDA, NIDDK, NIAAA, NCI, NHLBI, and other federal agencies like the FDA and DoD. Private funding for studies has come from organizations such as the Lupus Founda-tion, Autism Speaks, and the Thrasher Foundation.

— Clinical trials in the CTRC have been sponsored by corporations such as GlaxoSmithKline, Pfizer, King Pharmaceuticals, and Bayer Healthcare.

CTRC: CLINICAL & TRANSLATIONAL RESEARCH CENTER

BABY PICTURE

HIGHLIGHTS

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PILOT PROJECTSPILOT PROJECTSPILOT PROJECTSPILOT PROJECTSPILOT PROJECTS

— In 2008-2009, 89 applications were received, 15 of which were funded, totaling $725,000, including two core facilities. The funding resulted in 9 publications, 1 joint patent application between MUSC and CU, 5 awarded extramural grants, 7 pending grants, and 5 submitted grants, including one STTR application.

— In Fall 2009, the PPP organized a scientific retreat focused on cardiovascular diseases and sparked 7 new collaborations resulting, in 2 funded Pilot Projects. In Spring 2010, SCTR and the SC Bioengineering Alliance organized a scientific retreat focused on Bioengineering & Regenerative Medicine.

— In 2009-2010, 55 applications were received, 15 of which were funded, totaling $730,000.

NOVEL METHODOLOGIES

— The Drug Design & Synthesis Core provided services to 7 clinical & translational research projects at MUSC and USC.

— The 2D DIGE Gel Proteomics Core has provided services to 10 research projects at MUSC and CU on projects including alcoholism, cancer, preeclampsia, and liver disease.

— Work is continuing to expand the use of the Tele Health initiative in order to form the basis for a comparative effectiveness research initiative through SCTR. The success of the REACH MUSC Tele Stroke program has proven that telemedicine is a viable clinical and research tool.

SCTR Pilot Project Program (PPP)SCTR PPP is designed to facilitate meaningful clinical and translational research with an emphasis on diseases demonstrating significant prevalence in SC. The major goal of the program is to ensure that investigator initiated, hypothesis-driven clinical and translational research pilot projects are supported so that they can generate preliminary data to validate the need for a larger study.

SCTR funds a range of pilot projects in 3 broad categories: Discovery, Early Career, and Novel Methods & Technologies, in order to meet the investigator’s needs from multiple disciplines at various career levels. This approach helps to diversify the portfolio of translational pilot projects which are co-funded by MUSC and USC. Since 2007, SCTR has funded 38 collaborative projects involving investigators from different disciplines and institutions.

Discoveries from the 2008-2009 Funded Projects:— Team of investigators from MUSC, USC, and CU

developed a miniature-sized implantable pressure and oxygen sensor for postoperative use in pediatric cardiovascular surgery. PI: Dr. Tain-Yen Hsia, MUSC

— Another team from MUSC, USC, and MCG (Medical College of Georgia) found that HPV-16 levels in head and neck squamous cell carcinoma (HNSCC) were lower in African American (AA) males compared to European American (EA) males. This finding may help explain the health disparity between AA males and EA, the former who have a higher prevalence of HNSCC.PI: Dr. Marion Gillespie, MUSC

— An early preclinical development of an anticancer drug with a novel mechanism of action was conceived, synthesized, and tested in a mouse model at MUSC. This was a team effort between faculty members of MUSC and USC. PI: Dr. Charles Smith, MUSC

Ananda Amstadter Genetic Determinates of Stress Reactivity in Substance Dependent Individuals

Jeanette Andrews Community Engaged Scholars: Unmet health needs of individuals with disabilities; Importance of vitamin D as it relates to health status and disease; Periodontal disease prevention in the Gullah community; Improving the quality of life for children with severe disabilities; Cancer prevention and wellness in the African-American community; Youth and community suicide prevention

Carl Atkinson Nanoparticle Coupled Therapeutics to Inhibit Smoke- Induced Oxidative Inflammation in Allergic Rhinitis

Sondra Berger Nucleotide Stress Response for Cancer Drug Discovery

Gregory Brower Dynamic Organ Culture System for Myocardial Tissue Slices

Daping Fan Macrophage MicroRNA-155 and Atherosclerosis

Stanley Hoffman CSD Peptide Mitigates Radiotherapy-Induced Lung Injury/Fibrosis

John Lemasters Cyclosporin A Derivatives to Prevent Progression of Heart Failure

Campbell McInnes Selective Plk1 Anti-Tumor Therapeutics Through Polo Box Domain Inhibition

Ziad Nahas Deep Brain Stimulation Mediated Interactions Between Antiparkinsonian Drugs and ABCB1/P-Glycoprotein

Susan Newman A Survey of Unmet Needs after Spinal Cord Injury

Georgi Petkov Identification and Characterization of Potassium Ion Channels as New Therapeutic Targets to Control Overactive Bladder

Rick Schnellmann Treatment of Acute Kidney Injury with Suramin

Eleanor Spicer Targeting Nucleolin in Liver Transplantation; a Novel Strategy to Prevent Hepatitis C Infection

Hon Yuen Effects of Exercise Using Wii Fit to Reduce Fatigue Among African Americans with Systemic Lupus Erythematosus

2009-2010 Funded Pilot Projects P. Investigator P. Investigator P. Investigator Pilot Project Title

MUSC Principal Investigator USC Principal Investigator USC Principal Investigator

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Considering participation in research studies, giving blood, or Considering participation in research studies, giving blood, or having an x-ray taken may be very intimidating. However, the MUSC having an x-ray taken may be very intimidating. However, the MUSC College of Nursing worked with the disAbility Resource Center (ARC) to College of Nursing worked with the disAbility Resource Center (ARC) to introduce an interactive & unique approach to conducting research in the introduce an interactive & unique approach to conducting research in the community: The Photovoice Project.

My name is Alex Jackson and I am one of 10 photographers who have a variety of physical disabilities. I was injured at nine months old in a head-on collision with a drunken driver. I’ve been in a wheelchair most of my life, but I don’t let my disability stop me from achieving my goals. I recently learned how to drive using a joystick system. I’m a senior at the College of Charleston studying journalism and plan to earn a Master’s degree in communication.

From a Different PerspectiveBy: Alex Jackson, Research Study Participant

The Photovoice Project allowed volunteers to document their lives while living with spinal cord injury. Project facilitator Dr. Susan Newman described the creative freedoms of this project. The group snapped over 100 pictures, including beneficial ramps and detrimental barriers such as stairs, that limit our accessibility to interact with the community. The ultimate goal of the project was to inform the public and legislators of issues that affect those with physical disabilities. As a result, our efforts helped change the handicapped parking laws for South Carolina.

I hope by sharing my experience through articles, conversations, and the MUSCHero campaign I can encourage others to volunteer in the wide variety of medical research studies available. It is rewarding to know that I can help future spinal cord injury patients have a better quality of life. I am an MUSC Hero!

COMMUNITY ENGAGEMENT

— Collaborative partnerships have been built that enhance public trust as well as clinical and translational training, leading to faster dissemination and adoption of evidence-based programs.

— MUSC joined ResearchMatch—The first not-for-profit, national, disease-neutral, volunteer recruitment registry.

— Partnerships with collaborators at USC have generated memorandums of understanding with 10 school districts in 8 counties along I-95 to work together on community based research initiatives.

— Six Community Engaged Scholar grants were funded jointly by SCTR & MUSC Center for Community Health Partnerships.

DESIGN, BIOSTATS, EPIDEMIOLOGY, & ETHICS

— Consultations have been provided to over 64 investigators including 16 CTRC protocols and 12 protocols related to grant applications. Two manuscripts have been published or are currently in press as a result.

— Two abstracts with a translational theme presented at the MUSC Student Research Day by students collaborating with Dr. Paul Nietert have won awards.

— The conference “Resolving the Shortage of Organs for Transplantation: Ethics, Science & Technology” was held with the Rutland Institute for Ethics of Clemson University resulting in a publication by Drs. Brockbank, Swaja, Wueste, Sade. (J SC Med Assoc. In press.) The resulting publication will add to the statewide and national efforts to expand the availability of transplantable organs.

MUSC Hero Campaign

The MUSC Hero Campaign has saturated the community with positive messages about research. The launch of the campaign has begun to generate curiosity and enthusiasm in community members about opportunities to participate in local and national research studies. Over 230 studies at MUSC have used MUSCHero.org to recruit volunteers to participate. The website now receives over 50,000 hits per month.

HIGHLIGHTS

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The SCTR KL2 Scholar’s Program is a self-designed training program that supports qualified junior faculty and provides participants with valuable training through mentoring, research experiences, and guided expertise. It transitions scholars into becoming independent researchers by the end of their award. It culminates when a scholar submits an external grant application to the NIH, CDC, or other appropriate body for extramural funds launching their own independent research career.

“Achieving the Master of Science in Clinical Research degree provided me with a good feel of what tools were available and what I needed to conduct my research. It doesn’t make and what I needed to conduct my research. It doesn’t make one totally independent, but it gives participants some good one totally independent, but it gives participants some good insight into what’s needed, the process, and ability to address insight into what’s needed, the process, and ability to address strengths and resolve weaknesses,” said Dr. Christopher strengths and resolve weaknesses,” said Dr. Christopher Robinson, current KL2 Scholar.Robinson, current KL2 Scholar.

“An important component of the KL2 program is the ongoing “An important component of the KL2 program is the ongoing need for good communications between the scholars and need for good communications between the scholars and their mentors. We remind our scholars to seek advice, learn, their mentors. We remind our scholars to seek advice, learn, participate in career development, write papers, collaborate participate in career development, write papers, collaborate with their colleagues, but most importantly remain focused with their colleagues, but most importantly remain focused on the science,” Dr. Mark Chimowitz, Director of SOCRATES.on the science,” Dr. Mark Chimowitz, Director of SOCRATES.

MUSC’s KL2 Mentored Research Career Development MUSC’s KL2 Mentored Research Career Development Program Award current scholars: Program Award current scholars:

— Christopher Robinson, MD, is an assistant professor in the Department of Obstetrics and Gynecology.

— Keith T. Borg, MD, PhD, is an assistant professor in the Department of Emergency Medicine.

— Michael G. Hughes, MD, is an assistant professor in the , is an assistant professor in the Department of Surgery.

— Peter Tuerk, PhD, is an assistant professor in Psychiatry is an assistant professor in Psychiatry and Behavioral Sciences.

Training the Future of Clinical & Translational Research

EDUCATION

— The Society of Clinical Research and Translational Early Scientists (SOCRATES) was created. Cumulative monthly meeting attendance is over 300.

— The Academy of Mentors held its first retreat in Oct. 2009 to develop a university-wide mentoring program.

— The Core Clinical Research Training Course (CCRT) and Masters of Science in Clinical Research (MSCR) are currently being transitioned to an online format, with the ultimate goal of making it then available statewide and beyond. The CCRT course registered record numbers with over 100 attendees in the past 4 sessions.

— One KL2 Scholar has made an inventions disclosure statement through the MUSC Foundation for Research Development.

TL1 PRE-DOCTORAL TRAINING PROGRAM

The MUSC Southeastern Pre-doctoral Training in Clinical Research (SPTCR) program is designed to provide early exposure and appropriate training in clinical research methodology, the application of cutting edge technology to clinical research. Trainees shall become rigorous, high-quality, and proactive clinical investigators through the programs carefully designed, yet flexible, curriculum that enables students to ultimately function as clinical investigators in a multidisciplinary environment. The interactive environment involves students, faculty members, and mentors, and is structured around an intensive summer session, a one year “pull-out,” and the possibility of a PhD clinical track in the MSTP and DMD/PhD programs.

Dr. Christopher Robinson, pictured above, with his Senior Faculty Mentor, Dr. Newman.

Master of Science in Clinical Research (MSCR)

MSCR is the focal point for training and education in MSCR is the focal point for training and education in clinical research. The MSCR curriculum is adaptive, clinical research. The MSCR curriculum is adaptive, meeting the needs and critical skill sets required by meeting the needs and critical skill sets required by contemporary clinical researchers. The ability to adapt to contemporary clinical researchers. The ability to adapt to the changing environment is essential to building and the changing environment is essential to building and maintaining successful training programs. Contemporary maintaining successful training programs. Contemporary programs add emphasis in new areas such as: building programs add emphasis in new areas such as: building collaborative multidisciplinary teams; career collaborative multidisciplinary teams; career development in academic medicine; effective teaching; development in academic medicine; effective teaching; building research programs with the pharmaceutical building research programs with the pharmaceutical industry; and training to become future leaders and mentors. These programs still have fundamental core competencies in biostatistics and epidemiology.

— Over 150 individuals have completed the program and have accumulated over 900 publications and over $40 million in extramural research support.

“The MSCR program has evolved to encompass new content areas in this era of team science. We have an expanded curriculum that provides training in these new critical skills, yet remains well grounded in the discipline of science,” Dr. Thomas Hulsey, Program Director.*With contributions from Cindy Abole, MUSC PR

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DESCRIPTION:

SCTR Pilot Projects: 1) facilitate innovative, meaningful clinical and translational research, 2) promote scientific interactions between basic and clinical scientists, and between clinician-scientists and the community, 3) actively promote an interdisciplinary, interactive translational research culture and facilitate collaborations across many disciplines, 4) accelerate the process from discovery to innovation to improved patient care.

The KL2 program fosters the discipline of clinical and translational research and increases research capacity by training junior faculty. This is accomplished through a mentored program bridging clinical and translational research training with research independence. The program includes an option to pursue a master’s degree in clinical & translational science (or custom designed plan), a supportive environment, start-up research funds, and access to program faculty with demonstrated research expertise.

The TL1 program is designed to increase the number of well-trained researchers who will assume leadership roles in the design, conduct, and oversight of clinical and translational investigations in our region. The program provides appropriate training in clinical research methodology and exposure to cutting-edge technologies in clinical research.

In order to promote and facilitate clinical and translational science and broaden access to research resources, SCTR has developed a Voucher Program. Vouchers are designed to provide funding assistance for research services and supplies to enable the gathering of preliminary data for grant proposals, improve the science or safety of research projects, and/or develop a translational focus to research. Investigators are able to apply for SCTR vouchers by visiting the SCTR Programs Application and Request Kiosk (SPARK).

PROGRAM:

Pilot Projects

KL2 Scholars

TL1 Trainees

SCTR Vouchers

ELIGIBILITY:

PIs: Faculty members of SCTR affiliated institutions

Postdoctoral Junior Faculty

Predoctoral Degree Candidates

Principal Investigators

*Industry-initiated, Industry sponsored research studies do not qualify.

Funding Opportunities Available Through SCTR

SCTR Quick Financial Facts

Biomedical Informatics

TL1 Program

Pilot Projects

KL2 Program

CTRC

Other Programs

— SCTR’s award is approximately $19.5 million over 5 years

— Includes existing GCRC ($2M) & T32 ($525K) grants

— K12 Required Component ($750K)

— Essentially $25K in new funds for 10 required programs

10%

27%27%

17%11%11%

12%

22%

®

Working Together to Improve Research

The South Carolina Clinical & Translational Research Institute is one of 46 medical research institutions The South Carolina Clinical & Translational Research Institute is one of 46 medical research institutions working together as a national consortium to improve the way biomedical research is conducted across the working together as a national consortium to improve the way biomedical research is conducted across the country. The consortium, funded through national Clinical and Translational Science Awards (CTSA), shares a country. The consortium, funded through national Clinical and Translational Science Awards (CTSA), shares a common vision to reduce the time it takes for laboratory discoveries to become treatments for patients, and common vision to reduce the time it takes for laboratory discoveries to become treatments for patients, and to engage communities in clinical research efforts. It also is fulfilling the critical need to train a new to engage communities in clinical research efforts. It also is fulfilling the critical need to train a new generation of clinical researchers. The CTSA program is led by the National Center for Research Resources, generation of clinical researchers. The CTSA program is led by the National Center for Research Resources, part of National Institutes of Health.

Strategic Goals Guiding the ConsortiumStrategic Goals Guiding the Consortium

— Build national clinical and translational research capability — Build national clinical and translational research capability — Provide training and improve career development of clinical and translational scientists — Provide training and improve career development of clinical and translational scientists — Enhance consortium-wide collaborations— Enhance consortium-wide collaborations— Improve the health of our communities and the nation — Improve the health of our communities and the nation — Advance T1 translational research to move basic laboratory discoveries and knowledge into — Advance T1 translational research to move basic laboratory discoveries and knowledge into clinical testing clinical testing

For more information, please visit For more information, please visit CTSAWeb.org

South Carolina Clinical & Translational Research Institutehttp://sctr.musc.edu843-792-8300

Medical University of South Carolina125 Doughty Street, Suite 100 MSC 195Charleston, SC 29425