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Page 1: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

Annual Report 2014Research Administration

Page 2: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic
Page 3: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

Research plays a vital role in the diagnosis and treatment

of many diseases. Being part of an academic medical

center as the primary teaching hospital for the University

of Missouri-Kansas City Schools of Health Sciences, Truman

Medical Centers encourage our clinicians to participate in

studies that contribute to new medical knowledge.

Our students, residents and fellows, attending physicians,

pharmacists, nurses and other clinicians ask questions

and find answers to some of medicine’s most challenging

problems, including heart disease, cancer, diabetes and

emerging infectious diseases. Our patients are also able to

be part of the solution by participating in clinical research.

TMC’s involvement in clinical research is further strengthened

by our inclusion in the Midwest Cancer Alliance, a network

of hospitals and research organizations throughout Kansas

and western Missouri, united to bring leading-edge oncology

clinical trials, screening tools and educational opportunities

to the region. Because of our affiliation, TMC patients now

have even greater access to clinical trials.

This publication highlights just a few of the numerous

research studies conducted by members of the TMC Medical

Staff and employees during the past year. These projects

help to keep TMC on the cutting edge of medicine, clinical

care and science.

Mark T. Steele, MD

Chief Medical Officer

Mark Steele, MD

Page 4: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

CARDIOVASCULAR

Page 5: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin (PEGASUS)

Every 33 seconds someone in the United States dies from cardiovascular disease.

If you’ve had a first heart attack, the risk for another one is substantially increased. More than a third (35 percent) of women and 18 percent of men who survive a first heart attack experience a second one within six years after the first.

Preventing these second more deadly heart attacks is the catalyst behind the study sponsored by AstraZeneca

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

Primary Outcome Measures • Any event after randomization from the composite of cardiovascular death,

non-fatal MI, or non-fatal stroke.

Secondary Outcome Measures • Cardiovascular death after randomization (Time Frame: Within 1 year to 44

months)• All-cause mortality after randomization [Time Frame: Within 1 year to 44 months]

Estimated Enrollment: 21,000 Study Start Date: October 2010 Estimated Study Completion Date: November 2014 Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

EligibilityAges Eligible for Study: 50 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

CriteriaInclusion Criteria:• Person who had a heart attack within 1 - 3 years ago and at least one additional

risk factor: Age ≥ 65 years old, Diabetes requiring medication, Documented history of second prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.

• Females of child-bearing potential must have a negative pregnancy test at enroll-ment

• Persons who are currently taking aspirin between 75 and 150 mg once daily

Principal Investigator: Javed Ashraf, MD

Page 6: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

ARTHRITIS

Page 7: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (PRECISION)

In order to ensure the medicine one takes to treat one ailment doesn’t create another, this study compares the cardiovascular safety of celecoxib with the two most common-ly prescribed nonselective NSAIDs, ibuprofen and naproxen, in patients with osteoar-thritis or rheumatoid arthritis and established or be at high risk of developing cardio-vascular disease.

Patients with osteoarthritis or rheumatoid arthritis with or at risk of developing car-diovascular disease have been recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

Primary Outcome Measures • •The first occurrence of cardiovascular death (including hemorrhagic death),

non-fatal myocardial infarction, or non-fatal stroke (APTC composite endpoint). [Time Frame: up to 18 months]

Secondary Outcome Measures • •The occurrence of Clinical Significant Gastrointestinal Events (CSGIEs) [Time Frame:

up to 18 months] • •Patient’s Assessment of Arthritis Pain (VAS) Time Frame: up to 18 months ]• •The first occurrence of a MACE defined as the composite of cardiovascular death

(including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA [Time Frame: up to 18 months ]

Estimated Enrollment: 20,000 Study Start Date: October 2006 Estimated Study Completion Date: September 2015 Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

EligibilityAges Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Inclusion Criteria• •Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing

cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion Criteria• •Subjects have had a recent cardiovascular event, unstable cardiovascular con-

ditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;

• •Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial

• •Subjects require treatment with aspirin > 325 mg /day• •Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or

esomeprazole, etc.

Principal Investigator: Brenda Rogers, MD

Page 8: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

ASTHMA

Page 9: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients With Asthma (CPAP)

Could a device used to treat sleep apnea also help control asthma? The American Lung Association’s Asthma Clinical Research Centers (ACRC) is trying to answer that question.  

The ACRC’s current study, the Effect of Positive Airway pressure on Reducing Airway Reactivity in Patients with Asthma (CPAP), is examining whether the use of CPAP, which keeps airways open during sleep, makes airways more relaxed and thus improves asthma symptoms. With CPAP treatment, clean, humidified air is blown into the lungs in order to prevent airways from collapsing. Thus the chest and lungs are more expanded helping patients to breathe better.

Study Objectives: • To assess the effect of nocturnal CPAP on airway reactivity• To determine the durability of the effect over 12 weeks• To assess the safety, tolerability and adherence to this treatment• To explore if there are clinically meaningful benefits

It is the underlying hypothesis that asthma, although it may be initiated by aller-gic airway inflammation, is promoted by decreased tidal force fluctuations during recumbent sleep. If this is true, then treatments that increase tidal force fluctuations of airways should reverse these abnormalities. One treatment that increases tidal force fluctuations is continuous positive airway pressure (CPAP). CPAP prevents a fall in end expiratory lung volume and prevents closure of airways in dependent regions of the lung thereby permitting the stresses of tidal breathing to apply strain to airways. The objective of this study is to conduct a randomized, sham-controlled, multicenter study of 5 and 10 cm H₂O CPAP in order to verify these findings.

Estimated Enrollment: 192Study Start Date: July 2012Estimated Primary Completion Date: June 2014 (Final data collection date for pri-mary outcome measure

EligibilityAges Eligible for Study: 15 Years to 60 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Principal Investigator: Dr. Gary Salzman

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EMERGENCY MEDICINE

Page 11: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus “Stop MRSA”

For years, MRSA has been a hospital problem, but this bug’s movement into the com-munity is confounding health officials and complicating treatment options.

MRSA USA300, the most common clone among the community-associated isolates, has become the leading cause of skin and soft tissue infections among otherwise healthy individuals since its identification in the late 1990s, with the most common patient presentations including furuncles, carbuncles and abscesses.

Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has recently emerged as a cause of skin and soft-tissue infection (SSTI). In the current era of increasing CA-MRSA infections, the outpatient management of SSTIs has not been well studied. This trial evaluated oral off-patent antibiotics for outpatient treatment of patients with any of the three main types of acute uncomplicated SSTI, i.e., abscesses, infected wounds, and cellulitis.

Primary Outcome Measures Clinical cure at the Test-of-Cure Visit in the per protocol population. [Time Frame:7-14 days after the end of therapy (Days 14-21).] [ Designated as safety issue:No]

Secondary Outcome Measures Rates of change of erythema dimensions, composite clinical and microbiological cure, surgical procedures, and invasive/recurrent infections. Infections in household con-tacts, medication AEs, and time to normal activity and until analgesics are not used.

Enrollment: 2265 Study Start Date: March 2009 Study Completion Date: June 2013 Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

EligibilityAges Eligible for Study: 13 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

CriteriaInclusion Criteria:• Adult or child 13 years of age and older • Have a skin and soft tissue infection (SSTI) with all three local findings of erythema

(> 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling/induration. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria.

• Have the infected lesion for 7 days or less duration;• Are to receive outpatient treatment at enrollment/baseline;• Express willingness and ability to be contacted and return for re-evaluation

according to the study protocol;• Provide written informed consent (and for subjects ages 13-17, consent from their

guardian and assent);• Negative pregnancy test for subjects who are women of childbearing potential.

Principal Investigator: Mark Steele, MD

Amy Stubbs, MD

EMERGENCY MEDICINE

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TRAUMA

Page 13: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

Shock is a leading cause of death among American forces in battle, with many trauma victims dying of early hemorrhagic shock or from late septic shock.1 Shock is defined as circulatory collapse, when the arterial blood pressure is too low to maintain an adequate supply of blood to the body’s vital organs and tissues. Specifically, hemor-rhagic shock results when blood vessels are physically damaged while septic shock results when microbes or microbial products enter the blood stream. Despite advances in medical science, including the development of improved antibiotics, treatments for hemorrhagic and septic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim in the United States, is treated today largely as he or she would have been treated in 1970.

Study Objective: The overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield (medical corpsmen, combat med-ics), in civilian life (Emergency Medical System), or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought. This might be a Fire Support Specialist (FIST) team in a combat theater or a trauma center in the civilian health care system.

Estimated Enrollment: 12 Study Start Date: January 2011 Estimated Study Completion Date: December 2013 Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

EligibilityAges Eligible for Study: 21 Years to 65 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

CriteriaInclusion Criteria:• Blunt or penetrating trauma patients who meet TMC criteria for a trauma

activation.• These patients will typically be in shock and have blunt injuries or penetrating

trauma.• Patients must be alert, awake, oriented, and responsive and be English speaking

males or females between the ages 21-65.

Principal Investigator: Charles Van Way, MD

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ACTIVE STUDIES

PRINCIPAL INVESTIGATOR TITLE

Gregory, Thomas Impact of Pharmacist Discharge Counseling for Patients with Sickle Cell Disease

Bzowyckyj, Andrew Use of Neutral Protamine Hagedorn (NPH) insulin for treatment of prednisone-induced hyperglycemia. The proposal title is: “NPH insulin for prednisone-induced hyperglycemia”

Gregory, Thomas Standardized bowel regimen for patients on chronic opioids

Hermanns, David Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome

Algren, D. Adam Ratio of AST/ALT in Acetaminophen overdose versus rhabdomyolysis

Salzman, Gary Smoking Asthmatics Pilot Study: Smoking Asthmatics Cohort Study (SAPS)

Gary Salzman A Retrospective Study Validating the Diagnostic Accuracy of the Pulmonary Embolism Rule-Out Criteria (PERC) rule at an Urban Academic Hospital

Zweerink, K. (Scott) Evaluation of the Impact of a Medication Assistance Program on Hospital Readmission Rates

Ashraf, M. Javed (AHS #11-80) A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction

Anderst, James Children’s Mercy Hospitals and Clinics (SS11-123e) Period of PURPLE Crying® in the Intensive Care Nursery

Rogers, Brenda This is a double-blind, triple-dummy, randomized, multicenter study, using a 3-arm parallel group design. double blind, triple-dummy, parallel-group study of cardiovascular safety in osteoarthritis or rheumatoid arthritis patients with or at high risk for cardiovascular disease comparing celecoxib with naproxen and ibuprofen. Protocol #07-09

Van Way, Charles IRB #05-18: Biological response of trauma patients to standard trauma resuscitation therapy.

Jacobsen, Ryan Outcomes of Prisoners transported by EMS from Jail: A Retrospective Review

Bruce, Jared “(11-08e) The Impact of Cognitive Training in Multiple Sclerosis: A Double-Blind Randomized Controlled Trial”

Harper, Diane M Multispecialty Diabetes Intervention

Baweja, Paramdeep JOSTENT® Coronary Stent Graft / JOSTENT® GraftMaster (09 09 ‘Humanitarian Use Device - Covered Coronary Stent Graft)’

Steele, Mark Prevalence and risk factors for community associated clostridium difficile-associated disease among patients in the emergency department (09-05e)

Wallace, Billi Microperimetry is an efficacious clinical instrument for detecting early contrast sensitivity impairment which can serve as a surrogate marker for early detection of retinal lesions in patients with multiple sclerosis.

Harper, Diane M (Old IRB #: 11-16e) Females 9-26 years old receiving health care and Gardasil vaccination

Hackman, Jeffrey Research Study of the Asthma Protocol

Ashraf, M. Javed A randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin+ eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial infarction scheduled to undergo an early invasive strategy (#11-56)

Sommi, Roger (AHSIRB #10-31) R092670-SCH-3006 A Fifteen-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexi-ble-Dose Study of Paliperidone Palmitate Compared with Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults with Schizophrenia Who Have Been Incarcerated

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ACTIVE STUDIES

PRINCIPAL INVESTIGATOR TITLE

Nelson, Leigh Anne IRB # 12-02 A Multicenter, Open-label Study to Assess Hospitalization Rates in Adult Subjects with Schizophrenia Treated Prospectively for 6 Months with Aripiprazole IM Depot Compared with 6-month Retrospective Treatment with Oral Antipsy-chotics in a Naturalistic Community Setting in North America (ARRIVE)

Chen, Stuart IRB#09-23 A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease.

Steele, Mark CAPTURE-Clinical assessment program and teflaro utilization registry. A multicenter, retrospective cohort study to charac-terize the use of teflaro in the treatment of patients with acute bacterial skin and skin structure infection or community-ac-quired pneumonia

Maulik, Dev 08-31 Micro-Array Analysis of Angiogenesis Related Gene Expression in Fetal Growth Restriction

Kunjukunju, Nancy (AHSIRB Protocol #: 12-03e) Microperimetry and Spectral Domain Optical Coherence Tomography of Central Serous Choroidopathy

Malnar, Gerard Study #10-37 Paracervical Block Versus Nothing for Endometrial Biopsy; A randomized-Controlled Trial

Maulik, Dev Use of Uterine electromyography to diagnose term and preterm labor

Lakshmi Venkitachalam Patient’s Understanding of hypertension and perceived barriers to risk factor control: a mixed-methods approach to examin-ing care at the Sojourner Health Clinic

Mark Steele Study 10-19e: Ultrasound FIRST: Effect of initial bedside ultrasound on skin and soft-tissue infection management in the emergency dept.

Diane M Harper A Review of the Influenza, Pneumococcal and combined Tetanus, Diphtheria, & Pertussis Vaccination Rates of the Adult Population in the Family Medicine Clinic at Truman Medical Center Lakewood

Diane M Harper (12-17e), “Evaluation of the Population Seroimmunity to Poliomyelitis in the Greater Kansas City Area”

Gurmukh Singh Truman Medical Centers’ institutional performance on control of diabetes mellitus

Gurmukh Singh (12-20) Appropriateness of Fresh Frozen Plasma (FFP) utilization.

M. Javed Ashraf Use of Cholesterol-Lowering Statins Stains In Patients with Heart Failure

David Mundy Impact of Maternal Obesity on Perinatal Outcomes

Gary Salzman The Impact of implementing a Handoff Policy on the Quality of Residents Check out in Medical Intensive Care Unit.

Leigh Anne Nelson (Current IRB # 10-53) Recovery After an Initial Schizophrenia Episode (RAISE)

Fadi Bdair Utility of CT enterography in obscure GI bleeding prior to capsule endoscopy.

Mary Gerkovich Factors Related to Engagement in Medical Care

Andrew Smith Evaluation of National Patient Safety Goal 03.05.01 Anticoagulation Monitoring Adherence

Douglas Geehan 10-43e Incidence of Primary Care in the Injured Patient

Nelson Sabates IRB # 11-20 Protocol Title: C-01-11-008--An Open Label, Multi-center Extension Study of the Safety and Utility of the New Inserter of ILUVEAN (Fluocinolone Acetonide Intravitreal Insert ) 0.19 mg and the Safety of ILUVIEN in Subjects with Diabetic Macualar Edema.

Nilofer Qureshi IRB#11-32 “Mechanisms Involved in the Septic Shock Syndrome”

M. Javed Ashraf (#12-34e) Exploring Decision-Making Conversations in Coronary Artery Disease (CAD)

Page 16: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

ACTIVE STUDIES

PRINCIPAL INVESTIGATOR TITLE

Salzman, Gary “Long-Acting Beta Agonist Step Down Study” LASST IRB # 12 - 44

Mark Steele Prevalence of Pathogens in Cerebrospinal Fluid obtained from Emergency Department Patients

John Gianino IRB#12-18 “A Multicenter, Randomized, Double-Blind, Placeo-Controlled, Parallel-Group study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN 13837 Injection in Adult Subjects with Acute Spinal Cord Injury”

Diane M Harper 09-50 - A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 107 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection.

Abraham Poulose UMKC AHS IRB # 12-04 Measuring biomarkers to predict disease and therapy outcomes in patients with retinal vascular occlusions (RVO’s)

Gerard Malnar Study # 12-13 A randomized clinical trial to reduce post-cesarean delivery endometritis with extended spectrum antibiotic prophylaxis

Gurmukh Singh CK-MB testing capability: Is it appropirate to retain this capability in the era of Troponin testing?

Dev Maulik Study # 12-30 the effect of cytochrome P450 Eicosanoids on myometrial contractility

David Mundy CO-OP Trial: Community-based Outreach on Obesity in Pregnancy

Mark Steele IRB # 12-29: Surveillance and risk factor analysis of community-associated uropathogen antimicrobial resistance among emergency department patients with acute pyelonephritis in the United States

Jared Bruce (11-82e) Development of a Motivational Intervention to Improve Treatment Adherence in MS

Jennifer Santee Study 11-35e: Effects of Medication Reconciliation on Medication-Related Problems in an Ambulatory Care Setting

Sheshadri Madhusudhana Assessment of Knowledge of Hereditary Breast/Ovarian Cancer and Interest in Genetic Testing among African American Women

Mark Steele IRB #08-61: Strategies using Off-patent antibiotics for methicillin resistant staphylococcus aureus (“STOP-MRSA”) – A phase IIb, multi-center randomized, double-blind clinical trial

Andrew Smith An Evaluation of the Demographics of Patients Discharged with Atrial Fibrillation at an Urban Safety Net Hospital

Margaret Gibson 10-62e Balance Assessment of Athletes Pre and Post-Concussion Using a Video Game Balance Board System

David Lyon IRB #12-25 - Calcium Signaling in Lacrimal Gland Acinar Cells

Andrew Smith Barriers to Participation in a Cardiac Rehabilitation Program at an Urban Safety Net Hospital IRB 10-101e

Miranda Huffman Evaluating the Economic Impact of the Sojourner Free Health Clinic on the Community

Mark Steele Influenza Diagnosis, Treatment and Surveillance with Xpert Flu

Ashraf Gohar 12-58e “Does “Code Ice” improve time to cool in patients with cardiac arrest who are treated with therapeutic hypothermia?”

Dev Maulik 12-15e Fetal Speckle Tracking Echocardiography: Utility in Normal and Abnormal Gestations

Bridgette Jones Study 08-50e: A non-invasive approach to predict steroid sensitivity in patients with asthma

William Lafferty Study 08-73e: Pilot analysis of Truman Medical Center’s Patient Population

Page 17: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

MIDWEST CANCER ALLIANCE STUDIES

PRINCIPAL INVESTIGATOR TITLE

Sheshadri Madhusudhana CALGB-C40503 Breast Cancer-Stage 3-4

Sheshadri Madhusudhana CALGB-C40601- Breast Cancer-Surgery

Sheshadri Madhusudhana CALGB-C80702-Stage 3 Colon Cancer

Sheshadri Madhusudhana CALGB-C90203-Prostate Cancer Surgery

Sheshadri Madhusudhana SWOG-E1505-Non Small cell lung cancer

Sheshadri Madhusudhana ECOG-E3805-DNA Prostate Cancer

Sheshadri Madhusudhana SWOG-S0221-Adjuvant Breast Cancer

Sheshadri Madhusudhana SWOG-S0819-Stage 4 Non-Small Cell lung cancer

Sheshadri Madhusudhana SWOG-S1007-Invasive Breast Cancer

Sheshadri Madhusudhana Lapatinib Metastatic Breast Cancer study

Sheshadri Madhusudhana NSABP-43 Breast Cancer

Sheshadri Madhusudhana Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Desease Following Metastatectomy ECOG-E2810

Sheshadri Madhusudhana A Randomized Double-Blinded Phase III study in Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitibine, Cispla-tin & Placebo in Patients with Advanced Transitional Cell Carcinoma CALGB-C90601

Sheshadri Madhusudhana Randomized Phase III trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Melanoma ECOG- E3A06

Sheshadri Madhusudhana A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTI. A4 Therapy Versus High Dose Interferon alpha-2b for Resect-ed high Risk Melanoma ECOG-E1609

Sheshadri Madhusudhana A Double-Blind Placebo controlled Trial of Eflomithine and Sulindac to Prevent Recurrence of High-Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer SWOG-S0820

Sheshadri Madhusudhana Phase III Randomized Study of Everolimus versus Placebo in Patients with Renal Cell Carcinoma who have Undergone Nephrectomy or Partial Neprectomy SWOG-S0931

Sheshadri Madhusudhana A randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based On ERCCI ( Excision Repair Cross-Complementing 1) for Advanced Metastatic Esophageal, gastric or Gastroesophageal Junction (GeJ) Cancer SWOG-S1201

Sheshadri Madhusudhana A phase III RT comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy+ Bicalutammide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer SWOG-S1216

Madhu A registry for patients with triple negative breast cancer and germline mutations TNBC

The Midwest Cancer Alliance, also known as MCA, is a membership-based organization that brings together cancer research, care and support professionals to advance the quality and reach of cancer prevention, early detection, treatment, and survivorship in the Heartland. As a clinical research partner, Truman Medical Centers participates in clinical studies to further promote the Alliance’s goals.

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RESEARCH ADMINISTRATION STAFF

Mark Hecker, PharmD, MBA Director of Research

Administration Office of Research Administration

Jorang (Jo) Kenty Grant Specialist Office of Research Administration

Fang (Fannie) Liu Grant Specialist Office of Research Administration

Tim Quinn Senior Lab Technician Office of Research Administration

Patricia (Pat) Weary, MBA Grant Specialist Office of Research Administration

Page 19: Research Administration Annual Report 2014 Report 2014 Research Administration Research plays a vital role in the diagnosis and treatment of many diseases. Being part of an academic

STUDY COORDINATORS

Clinical Trials are increasingly complex. That’s why the role of the study coordinator is crucial to the success of any clinical research.

They are tasked with an expanding set of responsibilities including patient safety and recordkeeping, federal regulations compliance, IRB compliance, interacting with Sponsors and Clinical Research Organizations and dealing with budget and contract negotiation.

This list of current TMC Study Coordinators are vital to TMC’s Research Administration team:

Danielle Beckham Emergency Department

Kim Dyer Trauma Services

Patti Haney Pulmonary

Mickie Keeling Trauma Services

Laurie Kemble Emergency Department

Nikki (Domonique) Malomo Oncology

Hollie McKinney Family Medicine

Nicole Neal Emergency Department

Mary Reed Internal Medicine

Eunice Riddle Women’s Health

Doug Ross Cardiology

Denise Sharp Oncology

General inquires to the Office of Research Administration and Grant Proposal Submissions should be sent to: [email protected] Fax: 816-235-6689

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© 2014 Truman Medical Centers #4227 Research Annual Report 6-2014