Results Methods A Five-Year Snapshot of Our Hereditary Hemochromatosis Program: A Work in Progress P Davenport 1, D Echols 1, J Giacoletti 1, L Sutor 1,2,

Slides:



Advertisements
Similar presentations
1 Conflicts of interest Different types, different contexts.
Advertisements

Welcome to Game Lets start the Game. An electronic health record (EHR) is a digital version of a patient’s paper chart. EHRs are real-time, patient-centered.
Regulatory Clinical Trials Clinical Trials. Clinical Trials Definition: research studies to find ways to improve health Definition: research studies to.
Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob.
Public Workshop: Quarantine Release Errors in Blood Establishments September 13, 2011 QREs Past, Present and Future Sheryl A. Kochman Deputy Director Division.
IRB Determinations 1. AAHRPP Site Visit Results Site visitors observed a real commitment to human subject protections Investigator and research staff.
Clinical Trials Medical Interventions
U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.
Capturing and Reporting Adverse Events in Clinical Research
CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues.
What Happens after You Sign with Missouri Health Information Technology Assistance Center?
Americas Technical Advisory Group ICCBBA ISBT 128 Blood Product Labeling – A Hospital Perspective Americas Technical Advisory Group ICCBBA.
Medical Devices Approval Process
QUALITY ASSURANCE IN BLOOD BANKING
Current standards, donor safety, and blood supply
Interpreting Adverse Signals in Diabetes Drug Development Programs Featured Article: Clifford J. Bailey, Ph.D. Diabetes Care Volume 36: 1-9 July, 2013.
Cohort Studies Hanna E. Bloomfield, MD, MPH Professor of Medicine Associate Chief of Staff, Research Minneapolis VA Medical Center.
Good Manufacturing Practices for Blood Establishments
Is this Research? Exempt? Expedited?
CBER U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.
Top 5 OPTN Policy Violations
FDA Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components.
Quick Facts about Exempt Research No continuing review required IRB Reviewer makes Exempt determination 6 OHRP & 4 FDA categories(1 category overlaps)
How to Find and Access Clinical Trials New Treatments, No Tricks A Seminar on Minority Participation in Clinical Trials June 15, 2010.
Adverse Events, Unanticipated Problems, Protocol Deviations & other Safety Information Which Form 4 to Use?
CBER Review Considerations on Source Plasma Vaccination Programs Judy Ellen Ciaraldi BS, MT(ASCP)SBB, CQA(ASQ) CBER, OBRR, DBA September 16, 2009.
Section 10.2: Errors in Hypothesis Testing. Test Procedure – the method we use to determine whether H 0 should be rejected. Type 1 Error: the error of.
Testing People Scientifically.  Clinical trials are research studies in which people help doctors and researchers find ways to improve health care. Each.
IN THE NAME OF GOD Blood Safety S. AMINI KAFI ABAD CLINICAL AND ANATOMICAL PATHOLOGIST IRANIAN BLOOD TRANSFUSION ORGANIZATION(IBTO) RESEARCH CENTER June.
Medical Law and Ethics Lesson 2: Patient/Physician Relationship.
Therapeutic Response to Azacitidine (AZA) in Patients with Secondary Myelodysplastic Syndromes (sMDS) Enrolled in the AVIDA Registry 1 Prospective Trial.
Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin McClure, PhD Department of Psychiatry and Behavioral Sciences.
SPCAA Head Start & Early Head Start Mental Health and Disability.
Stop the Clot ™ David Henry and Tom Hogan Cardiovascular and Renal Drugs Advisory Committee U.S. Food and Drug Administration Adelphi,
Planned Emergency Research Exception from Informed Consent Requirements September 2007.
1 Donor’s Written Statement of Understanding Beth H. Shaz, MD Chief Medical Officer New York Blood Center Clinical Associate Professor Emory University.
Security of the Distributed Electronic Patient Record: A Case-Based Approach James G. Anderson, Ph.D. Purdue University.
Real-World Assessment of Clinical Outcomes in Lower-Risk Myelofibrosis Patients Receiving Treatment with Ruxolitinib Davis KL et al. Proc ASH 2014;Abstract.
The Compelling Business Case for Building Better Hospitals The Quality Colloquium August 20, 2008 Blair L. Sadler, JD Past President/CEO Rady Children’s.
Consent for Research Study A study for patients diagnosed with locally advanced breast cancer Learning if the imaging agent, [ 18 F] fluorothymidine (FLT),
Some Observations on the Deferral of Volunteer Blood Donors for nvCJD Risk Merlyn H. Sayers, M.B., B.Ch., Ph.D. Carter BloodCare Dallas/Fort Worth, Texas.
Consent for Research Study A study using 18 F-Fluoride for prostate cancer patients currently enrolled in Dr. Febbo’s “Genomic Guided Therapy” study A.
Abbreviated Donor History Questionnaire: Background and Introduction Sharyn Orton, Ph.D. OBRR/CBER/FDA Blood Products Advisory Committee March 2005.
Dispensary and Administration Site Information Presentation.
Barcode Technology in healthcare Nowadays, published reports illustrate high rates of medical error (adverse events) and the increasing costs of healthcare.
Inside Clinical Trials ® ALL RIGHTS RESERVED. What is a clinical trial? ALL RIGHTS RESERVED.
Investigational Devices and Humanitarian Use Devices June 2007.
Understanding Clinical Trials – Part 2 Georgianne Arnold, MD Professor of Pediatrics University of Pittsburgh Medical Center Pittsburgh Children’s Hospital.
HHS Secretary’s Advisory Committee on Blood Safety and Availability Summary for FDA’s BPAC July 2010 Jerry A. Holmberg, Ph.D. Senior Advisor for Blood.
Levels of Review of Research and Quality Improvement Walter Kraft, MD Associate Director, Office of Human Subjects Protection Department of Pharmacology.
1 National Quality Forum Patient Safety Initiatives Melinda L. Murphy, RN, MS, CNA.
Institutional Review Board (IRB) for Human Subject Protections: Working with the IRB Erin A McClure, PhD Department of Psychiatry and Behavioral Sciences.
OVER THE COUNTER MEDS INTRODUCTION No prescriptions are necessary and no questions need to be answered to attain these drugs OTC med use saves.
Karen Cheung, MPH, Pamela Luna, DrPH, MST, Sarah Merkle, MPH American Evaluation Association Annual Meeting November 11, 2009 The findings and conclusions.
Informed Consent Presented by Marian Serge, RN. Goals Informed consent process and form Title 38 CFR , Common Rule required elements and additional.
CBER Current Considerations for Blood Donor Screening for West Nile Virus Pradip N. Akolkar, Ph.D. Maria Rios, Ph.D. DETTD, OBRR Blood Products Advisory.
PRAGMATIC Study Designs: Elderly Cancer Trials
CLINICAL TRIALS.
Donations After Reentry
Susan Sonne, PharmD, BCPP Chair, MUSC IRB II

METHODS SECTION OF A RESEARCH PROPOSAL
Clinical Trials Medical Interventions
Bozeman Health Clinical Research
Himika Patel, Pharm. D. , Matthew Bermudez, Pharm. D
Feasibility Study) PB-PG
Lana Gevorkyan Corporate Director Human Research Protection Program
Clinical Trials.
Tobey Clark, Director*, Burlington USA
NAACCR/IACR Annual Conference, June 2019
Presentation transcript:

Results Methods A Five-Year Snapshot of Our Hereditary Hemochromatosis Program: A Work in Progress P Davenport 1, D Echols 1, J Giacoletti 1, L Sutor 1,2, J Chiu 1 1 CarterBloodCare, Bedford, TX, 2 University of Texas Southwestern Medical Center, Dallas, TX Background Conclusions References FDA Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis, August During the five year period 380 HH patients enrolled in the program. Of these 68% (259) qualified as AL donors. The other 32% (121) were either ineligible or did not wish to donate AL and were drawn as TH only. The AL HH donors presented to donate 2078 times during this period. Of those donation attempts 66% (1375) were successful as AL donations, 11% (231) were unsuccessful attempts by AL HH donors who were deferred at time of donation as a result of eligibility criteria and 23% (476) were mistakenly drawn as TH due to staff error. Over the 5 year period, the AL HH donor group presented to donate an average of 8 times per donor, whereas TH HH donors presented an average 10 times each. A significant number of enrolled AL HH donors (36%) had not donated in over a year or had never donated. Overall, our HH program resulted in an average of 5.5 usable AL donations per AL HH donor over the 5 year period. A financial analysis of our HH program did not recognize a monetary gain for our institution, but 1375 allogeneic units were collected and this number could be improved by reducing staff errors and increasing enrollment of eligible AL HH donors. Carter BloodCare, AABB 2014 Data was gathered from existing records of all AL HH and TH HH donors enrolled in the program, delineating number and type of donations, AL HH donor deferrals, and errors. To assess the cost effectiveness of the program we compared costs (“no-fee” TH phlebotomies and estimated employee time) to benefits realized as a result of the program and future potential. In 2001, the Food and Drug Administration (FDA) issued guidance to the blood industry allowing a variance, if approved, to collect blood from individuals diagnosed with hereditary hemochromatosis (HH) and distribute those donations to hospitals without labeling them with the donor’s condition. Concern exists that blood donation by HH patients would provide indirect compensation for medical treatment and create an incentive to deny health or risk conditions that would preclude cost-free donation, thus requiring payment for therapeutic phlebotomy. To avoid this, FDA requires that no fees be collected from HH donors whether they qualify to donate allogeneic (AL) blood intended for transfusion or are drawn only for therapeutic purposes (TH). Five years after implementing our HH program, we evaluated its efficacy. From phlebotomies performed for all enrolled donors (AL and TH), 42% were usable for transfusion, but the potential would be 56.5% if errors could be eliminated. Because no fees are collected for TH procedures, administrative and material costs cannot be recouped. However, some administrative costs for transfusable units are offset because AL HH donors do not require recruitment and all procedures are conducted at select non-mobile sites.