The Office of Clinical Research

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The Office of Clinical Research Henry Parkman,
MD Professor of Medicine Director, The Office of
Clinical Research and GCRC
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Temples Office of Clinical Research

• A centralized resource for clinical researchers
  throughout the health sciences center.
• OCRs mission is to enhance and help to
  facilitate funded clinical research
  opportunities.
• OCR provide services on a variety of issues
  related to obtaining and conducting quality
  clinical research studies.

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The Office of Clinical Research at Temple
University Health Sciences Center

• Office of Clinical Trials Clinical research
  specialists (2)
• (FSU Bldg 4th floor) Grant/finance manager (1)
• PharmD training program in clinical research
  (2-4)
• Research nurse coordinators (2)
• Research Quality Improvement Training of clinical
  coordinators
• Education for investigators
• Audit assistance
• Biostatistics Statistical support on all phases
  of research
• Protocol/grant development
• Review all clinical research protocols at
  IRB
• Clinical Research Center Inpatient rooms (3) and
  outpatient room (1)
• (TUH 4 west) Nursing coverage 24/5
• Core laboratory with 2 technicians
• Research Subject Advocate
• Research Nutritionist

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Reporting Structure of the Office of Clinical
Research

Office of the Provost Ira Schwartz, Ken Soprano
Deans HSC Council Deans of the Health
Sciences (Medicine chair, Pharmacy, Podiatry,
Dental, Health Professionals)

Dean, School of Medicine John Daly, MD
Office of Clinical Research Henry Parkman, MD
Acting Director of OCR and GCRC
Office of Clinical Trials Bill Hirschhorn, MS
Director of Office of Clinical Trials Research
Quality Improvement Regulatory Consultant and
IRB/Budget/Contracts/Recruitment Craig Pfister,
BS, CCRP Clinical Trials Specialist IRB
Submission Consultant Arlene Wallen, MS, MBA
Financial Manager Budget Development and
Negotiation Contract Manager/Paralegal
Candidate Selection Process

Ongoing Interactions with OCR Active Advisory
Committees to OCR IRB Departmental
Advisory Committee Office of Sponsored
Projects Departmental Point Persons
PharmD Training Program Clinical
Research GCRC Biostatistics in
Clinical Research Coordinators 1-2
new PharmDs per year via OCR (2)
3 rooms/beds 1 biostatistician for 2 years
each for studies
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What OCR/OCT are currently doing for Temple
Investigators

• Bring clinical trials to Temple University
• Help with study start up IRB, regulatory
  submissions
• Develop/Negotiate appropriate budgets
• Provide clinical coordinators to help with
  studies
• Help develop patient recruitment strategies
• Assist with regulatory compliance for ongoing
  studies
• Audit assistance
• Educational programs for investigators,
  coordinators

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What can OCR do for Pharma/Sponsors?Meetings
With GlaxoSmithKline, AstraZeneca

• Match principal investigators with sponsor
  clinical studies
• Develop strategies for patient recruitment
• Work with sponsor in negotiating mutually
  acceptable budgets
• Expedite contracting process with Master
  Agreements
• Monitor research and data quality  Ensure
  regulatory compliance

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Delay in Clinical Trial Startup Solving Some
Problems

• Infrastructure Office of Clinical
  Research/Clinical Trials
• Electronic Research Administration
• Adverse events
• Protocols
• More clinical trials OCR initial contact
• Super Site
• Budget for trials Benchmark with Budget Builder
• IRB takes too long National IRB (WIRB)
• Contract takes too long Master contracts
• Signature
• No clinical coordinators PharmD/Nurses in OCR
• SOCRA

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Some Next Frontiers for Temple OCR

• Better tracking of finances (billings/collections)
  of clinical trials
• Finance manager started in OCT April 2004
• ?InfoEd computer software coming soon
• Increase the number of experienced clinical
  coordinators
• PharmD and clinical coordinator programs - now
  have 4 individuals
• Move to a commercial IRB for pharmaceutical
  studies
• Decrease time for IRB approval, increase trials
• Improve patient recruitment in clinical studies
• Identify and develop (or recruit) more successful
  clinical investigators
• Develop department specific databases for
  conditions/diseases
• Get a running start for patient recruitment
• Use Temples minority population as a drawing
  card for studies at Temple
• Improve contract and budget negotiation turn
  around time

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Patient Enrollment and Collections for Clinical
Trials at Temple

• Clinical Research Studies at Temple
• Enroll 30 of projected/anticipated subjects
• Some studies, enroll none.
• Low study enrollment implies low collection rate
• Rigid entry criteria in increasingly
  complicated studies
• Competitive enrollment for studies
• Enrollment is generally low in academic centers
  
• Delay in IRB approval, contract
• Lack of clinical coordinators
• Lack of investigator time
• Task To increase patient enrollment and
  retention in clinical research studies at Temple.

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Email Notices of Clinical Research Studies

• Dr. Henry Parkman of the Temple Universitys
  Gastroenterology Section is conducting a clinical
  research study in Diabetic Gastroparesis and
  would appreciate patients interested in
  participating in this study.
•  
• The research study is to determine whether
  Zelnorm (Tegaserod), which is already approved
  for another condition, helps relieves the
  symptoms of diabetic gastroparesis.
• To qualify for this study, patients must
• Be between 18 and 65 years old
• Have diabetes requiring insulin for at least 3
  years
• Have experienced some of the symptoms listed
  below for at least 2 months.
• Early sense of fullness with eating, mid to
  upper abdominal pain or discomfort, bloating,
  nausea or vomiting
•  
• Patients are not eligible if they
• Have had prior stomach, pancreas, intestinal
  surgery
• Unable to stop prokinetic medications such as
  reglan, domperidone, zelnorm
• Significant diarrhea (gt3 watery stools per day)
• Poor glucose control
•  
• This study requires 5 visits over a period of 12
  weeks and involves study-related blood work, EKG,
  endoscopy, and a breath test for screening
  purposes. All study-related care is provided at
  no charge to those who take part. Study patients
  will receive 125 after completion of the study
  for compensation for participating in this study.
•  
• If you have patients that might be interested in
  participating, please have them call (215)
  707-5477 and ask for Amiya Palit. Alternatively,
  call Dr. Henry Parkman at 2-7579 or on beeper
  1938.
•  

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Notice of a Clinical Research Study at Temple
University on Diabetic Gastroparesis /
Gastropathy
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Tap into the Temple Patient Population

• For Temple University Hospital for the year 2003,
  the total number of outpatient registrations were
  251,077 and the number of inpatient admissions is
  27,257. The total number of distinct patients
  was 54,469.
• The combined Temple University Health systems
  (including TUH, Episcopal Hospital, Temple
  Childrens Hospital, Northeastern Hospital, and
  Jeanes Hospital) had approximately 166,000 ER
  visits, approximately 56,000 inpatient
  discharges, approximately 317,000 outpatient
  visits, performed approximately 26,000 surgical
  procedures and had approximately 7,440 visits to
  the Psychiatric Crisis Response Center at
  Episcopal Hospital.
• Some of the most prevalent discharge diagnoses
  include congestive heart failure, acute
  respiratory failure, diabetes mellitus, chest
  pain, coronary artery disease, pneumonia,
  paranoid schizophrenia, asthma, urinary tract
  infection, syncope, HIV disease, obesity, and
  cerebrovascular disease (i.e., stroke).
• Temple has immediate access to diverse and broad
  minority population that would lend itself to
  Federally mandated population-specific clinical
  trials. Approximately 41 of our patients are
  female. In addition, 51 of our patients are
  African American, 13 are Hispanic, and 23 are
  Caucasian.

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GCRC Scientific Advisory Committee (GAC)

• GCRC Advisory Committee
• Martin Goldberg, MD (Chairman) Professor of
  Medicine emeritus, Renal, Prior TUSM Dean
• Guenther H. Boden, MD Professor of Medicine,
  Chief of Endocrinology
• Koneti A. Rao, MD (Deputy Chairman) Professor of
  Medicine, Hematology Section
• Robert W. Colman, MD Professor of Medicine,
  Chief Hematology and Thrombosis
• Steve Gelone, PharmD Adjunct Associate Professor
  of Pharmacology
• Friedrich Kueppers, MD Professor of Medicine,
  Pulmonary Section
• Kenneth Margulies, MD Associate Professor of
  Medicine, Cardiology Section
• Joel Richter, MD Professor of Medicine,
  Chairman of Medicine
•  
• Program Directorship
• Henry P. Parkman, MD (Program Director) Professor
  of Medicine, Gastroenterology Section
• Michael Bromberg, MD (Assistant
  Director) Associate Professor of Medicine,
  Hematology Section
• John Daly, MD (Principal Investigator) Professor.
  Dean of Temple Medical School
• John Gaughan, PhD Biostatistican. Associate
  Professor of Medicine, Physiology
• Craig Pfister, MS Clinical Trials Specialist
  Office of Clinical Trials
• Margaret Kerper, RN Clinical Nurse
  Coordinator, OCT and GCRC
• Carol Homko, RN, PhD GCRC Research Head Nurse,
  GCRC
• Robert Faust Administrator, GCRC

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GCRC Research Beds Needed for Week of September
20, 2004
Please call Carol Homko at 215-707-3784 for
questions.
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A Final Message !

• The Office of Clinical Research including
  Clinical Trials, Research Quality Improvement,
  Biostatistics, and the GCRC are here to provide a
  full range of support mechanisms and services to
  support Temple University faculty conduct high
  quality clinical research.