ANSWERINGTODAY’S QUESTIONSFOR TOMORROW’SWORLD

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OUR MISSIONTo develop and share knowledge

that improves the care of patients around the world through

innovative clinical research.

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Manuscript Productivity

Trial Experience by Phase and Size: July 1, 2014–June 30, 2015

Publ

icat

ions

0

100

200

300

400

500

600

700

1996

800

900

1000

1100

High impact manuscripts published in journals with an impact factor greater than 10.0 (<2% of all indexed journals)

138

14

2013 201420111997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2012

764

154 175234 262 286

333408

490494

542 512

621654

756

514 12 36121 97 121 161

39 4153 57 51 55

167

949

197

964

198

1081

235

49%

Small( 1–499 patients )

27%

Mega( > 5,000 patients )

6%

Large( 2,000–4,999 patients )

18%

Medium( 500–1,999 patients )

3%

Phase I 15%

Phase II 36%

Other/Registry

30%

Phase III 16%

Phase IV 63.3 %Commercial

36.7%

Government

Project Portfolio:July 1, 2014–June 30, 2015

DCRI AT A GLANCE

More than 10,000 DCRI Publications

At the DCRI, we: • Expand the impact of clinical research beyond drug approval• Design trials that shape the clinical standards of tomorrow• Translate the patterns of Big Data into actionable insights• Welcome the contribution of everyone to the story of better care for all• Activate the next generation of research forerunners

We are committed to: • Bringing the promise of personalized medicine to reality• Leading innovations in research design and operations• Supporting novel outcomes research and implementation• Moving quantitative science forward• Designing the educational platform of the future• Catalyzing global and community-based research

OUR STRATEGIES FOR TODAY AND THE FUTURE

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The DCRI has: • 37,000 sites in 65 countries• 1,000+ phase I-IV clinical trials, and registry, outcomes, economic, and imaging studies• 1.2+M patients enrolled in DCRI studies • 9,300+ publications in peer-reviewed journals• 1,200 employees, including more than 200 Faculty• 35 Fellows from 7 countries• 900 faculty publications annually

North America • Canadian VIGOUR Center – Edmonton, AL • Canadian Heart Research Centre – Toronto, ON• Cleveland Clinic – Cleveland, OH• Harvard Clinical Research Institute – Boston, MA• Population Health Research Institute – Hamilton, ON• Stanford Center for Clinical Research – Palo Alto, CA• TIMI Study Group – Boston, MA• Colorado Prevention Center – Denver, CO• Mayo Clinic – Rochester, MN• Henry Ford Health System – Detroit, MI

Europe • Cardialysis – Rotterdam, NL• Leuven Coordinating Centre – Leuven, BE• Uppsala Clinical Research Center – Uppsala, SE • French Alliance for Cardiovascular Clinical Trials – Paris, FR• Diabetes Trial Unit – Oxford, UK

Latin America • Brazilian Clinical Research Institute – São Paulo, BR• Estudios Clínicos Latinoamérica – Buenos Aires, AR• Trials Argentine Group Organization – Buenos Aires, AR

Asia-Pacific • Medanta – Gurgaon, India • South Australian Health and Medical Research Institute – Adelaide, AU • The George Institute – Sydney, AU• Singapore Clinical Research Institute – Singapore • Flinders Medical Center – Adelaide, AU

FAST FACTS

PARTNERS AROUND THE WORLD

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2015 • The National Institute of Allergy and Infectious Diseases (NIAID) announces that the DCRI will become one of three national sites to run early clinical trials of new anti-infection therapies. The DCRI could launch and manage up to four early-phase clinical trials a year, and potentially receive $90 million over the life of the 10-year contract.

• DCRI Founder Robert Califf named deputy FDA commissioner, then nominated to be FDA commissioner.

• A DCRI study finds that almost one quarter of thyroid cancer patients receive unnecessary treatment.

• Kristin Newby, MD, MHS, named principal investigator for MURDOCK Study.

• DCRI researchers find that results from most clinical trials of medical products are not reported to ClinicalTrials.gov, despite legal requirements to do so.

• The DCRI announces the launch of the Center for Community and Population Health Improvement under the direction of Ebony Boulware, MD, MPH.

• A 2011 study conducted by Daniel Benjamin, Jr., MD, MPH, PhD, and other DCRI researchers results in the FDA relabeling the antibiotic meropenem.

• The DCRI is awarded the first PCORnet demonstration study to determine the best aspirin dose to protect patients with heart disease (ADAPTABLE).

• DCRI’s Clinical Trials Transformation Initiative receives 2015 DIA Regional Inspire Award for the Americas.

• DCRI faculty members, including Michael Pencina, PhD, and Adrian Hernandez, MD, MHS, are named as editors of a new journal, JAMA Cardiology.

• The DCRI’s Evan Myers, MD, MPH, contributes to the development of the American Cancer Society’s new breast cancer screening guidelines.

2014 • New statistical framework devised by DCRI investigators and colleagues allows researchers to better analyze rare genetic variation.

• The DCRI, with Boehringer Ingelheim Pharmaceuticals, Inc., launched a patient registry to help researchers and clinicians identify, manage and study people who have a progressive lung disease called idiopathic pulmonary fibrosis. The registry is the first multi-center registry in the United States focused specifically on idiopathic pulmonary fibrosis.

• The National Heart, Lung, and Blood Institute announces that the DCRI, in conjunction with RTI International, will serve as data coordinating center for the Molecular Atlas of Lung Development Program (LungMAP).

• DCRI research findings lead to new guidelines for statin use.

• DCRI research points to new recommendations to relax blood pressure medication guidelines for millions of patients.

RECENT MILESTONES

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RECENT MILESTONES

CORE CAPABILITIES

2013 • The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors has selected a consortium with Robert Califf as co-principal investigator to serve as the Coordinating Center for a major new national clinical research network

• SAFE-PCI, a trial of many “firsts,” announces database lock, paving the way for the future of clinical trials.

• The NIH awards a $6 million grant to the DCRI’s Vance Fowler, MD, MHS, to form a national leadership group focused on antibacterial resistance. ARLG research network will target the problem of antibacterial resistance

• New DCRI education program allows high school students and undergraduates to explore careers in clinical research

2012 • Eric Peterson, MD, MPH, becomes the DCRI’s third director since its inception

• The DCRI and Duke Translational Research Institute awarded $6.4 million grant to develop and support the Lung Repair and Regeneration Consortium

• The DCRI awarded a $9 million grant to serve as the coordinating center for the NIH’s Health Care Systems Research Collaboratory

• The DCRI begins a clinical immunization safety assessment that has a potential contract value of up to $50 million over 10 years.

Transformational Clinical Trials • Phase I to Phase III • Thought leadership• Clinical trial design• Project management• Regulatory services• Site startup, site management• Data management• Statistics• Clinical monitoring• Safety surveillance• Clinical events review• Clinical hotline• Pharmacometrics • Biomarkers• Image analysis lab• Manuscripts

Health Services Research • Outcomes research • Quality improvement• Implementation science• Comparative effectiveness research• Medical decision making• Cluster randomized trials • Empirical bioethics• Drug and device safety• Health economics• Health policy• Methods development• Patient-reported outcomes• Decision modeling• Pharmacoepidemiology

Education Platform of the Future • Evidence to Practice Series • Fellows Education• DCRI Learning Lab• Site Network Education

RESEARCH THAT LEADS TO NEW QUESTIONS?

THAT’S RESEARCH DONE RIGHT

Contact Information

Suzanne Pfeifer, Director, Business Development Phone: 919.668.8196

Email: suzanne.pfeifer@duke.edu

dcri.org

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DCRI COMMUNICATIONS FEBRUARY 2016