WWW.DISSERTATION.XLIBX.INFO
FREE ELECTRONIC LIBRARY - Dissertations, online materials
 
<< HOME
CONTACTS



Pages:   || 2 | 3 | 4 | 5 |   ...   | 11 |

«11-18-2012 An Organizational Diagnosis Of A Centralized Investigational New Drug Core Within A Large Academic Health Center Kathleen M. Thomas ...»

-- [ Page 1 ] --

University of Pennsylvania

ScholarlyCommons

Master of Science in Organizational Dynamics

Organizational Dynamics Programs

Theses

11-18-2012

An Organizational Diagnosis Of A Centralized

Investigational New Drug Core Within A Large

Academic Health Center

Kathleen M. Thomas

University of Pennsylvania, kathleen.thomas@uphs.upenn.edu

Submitted to the Program of Organizational Dynamics In the Graduate Division of the School of Arts and Sciences In Partial Fulfillment of the

Requirements for the Degree of Master of Science in Organizational Dynamics at the University of Pennsylvania Advisor: Dana Kaminstein This paper is posted at ScholarlyCommons. http://repository.upenn.edu/od_theses_msod/60 For more information, please contact repository@pobox.upenn.edu.

An Organizational Diagnosis Of A Centralized Investigational New Drug Core Within A Large Academic Health Center Abstract This capstone examines the root cause of the ineffectiveness of a centralized Investigational New Drug (IND) core within a research department of a large Academic Health Center (AHC). This capstone utilized an organizational diagnosis approach to collect data to determine what is and is not contributing to the success of the core.

The hypotheses of this study are: 1) The centralized model was set in place without clear objectives; 2) The IND core is not operating in the way it was structured to operate; 3) The IND core is understaffed and unable to fully carry out the level of responsibility associated with being a Sponsor; and 4) Future expansion was not included in the planning phase. Data was collected by interviewing staff members, and participant observations. Prior to conducting the current state interviews, I conducted background interviews with previous staff members to determine the rationale behind centralization.

The results supported the importance of learning an organization's history prior to implementing a change, as well as the need for group development prior to the implementation of a new model within an organization.

The organizational diagnosis I conducted was able to confirm three of four of the hypotheses. I was able to uncover two variables that I did not consider before the diagnosis: role definition, and inter-group dynamics.

Comments Submitted to the Program of Organizational Dynamics In the Graduate Division of the School of Arts and Sciences In Partial Fulfillment of the Requirements for the Degree of Master of Science in Organizational Dynamics at the University of Pennsylvania Advisor: Dana Kaminstein This thesis or dissertation is available at ScholarlyCommons: http://repository.upenn.edu/od_theses_msod/60

AN ORGANIZATIONAL DIAGNOSIS OF A CENTRALIZED

INVESTIGATIONAL NEW DRUG CORE WITHIN

–  –  –

Submitted to the Program of Organizational Dynamics In the Graduate Division of the School of Arts and Sciences In Partial Fulfillment of the Requirements for the Degree of Master of Science in Organizational Dynamics at the University of Pennsylvania

–  –  –

This capstone examines the root cause of the ineffectiveness of a centralized Investigational New Drug (IND) core within a research department of a large Academic Health Center (AHC). This capstone utilized an organizational diagnosis approach to collect data to determine what is and is not contributing to the success of the core.

The hypotheses of this study are: 1) The centralized model was set in place without clear objectives; 2) The IND core is not operating in the way it was structured to operate; 3) The IND core is understaffed and unable to fully carry out the level of responsibility associated with being a Sponsor; and 4) Future expansion was not included in the planning phase. Data was collected by interviewing staff members, and participant observations. Prior to conducting the current state interviews, I conducted background interviews with previous staff members to determine the rationale behind centralization.

The results supported the importance of learning an organization's history prior to implementing a change, as well as the need for group development prior to the implementation of a new model within an organization. The organizational diagnosis I conducted was able to confirm three of four of the hypotheses. I was able to uncover two variables that I did not consider before the diagnosis: role definition, and inter-group dynamics.

–  –  –

This capstone is dedicated to the memory of my Dad, Philip G. McCarthy.

Unfortunately, my Dad is not here today to read this paper, but I can say with certainty that he would be proud of the hard work I put into this document. There have been many times during the writing process that I wanted to give up, but remembering how proud my Dad was of me for working towards this degree kept me going. Dad, thank you for teaching me the value of hard work and perseverance. Thank you for loving me and encouraging me to always do my best. You are an inspiration to me and your memory keeps me pushing forward. I love and miss you.

I would like to send a special thanks to my husband Tim, daughter Amelia, mom and sisters for believing in me and gently pushing me to complete this paper. Your endless love and support is much appreciated. I would not have been able to complete this without you.





Thanks to all of my friends and co-workers for encouraging and supporting me throughout this process. A special thanks to Julia for taking time out of your schedule to review and edit this paper. I would not have been able to do this without your assistance.

Thank you for being such a dear friend.

I would also like to extend my deepest thanks to my capstone committee. First and foremost, Dr. Dana Kaminstein for being supportive and encouraging me to put my best into writing this paper. Additionally, I would like to thank Alice Laneader and Dr.

John Pourdehnad for their countless efforts and willingness to be a part of this committee.

Thank you all!

–  –  –

Clinical research overview I have spent the past ten years working in the field of clinical research, growing (or expanding) my working knowledge and understanding of Good Clinical Practices (GCP) and regulatory requirements. Until recently, I have never explored the dynamics at play within this field, nor have I been able to locate much research on these dynamics.

This is one reason that this capstone research had particular appeal to me as it allowed me to use my knowledge of research regulations and organizational dynamics to diagnose one of the current systems in my workplace.

This capstone will evaluate the effectiveness of a centralized IND core at an Academic Health Center (AHC). My interest in this topic began two years ago when I was asked to oversee the operations of the IND core. Since then I have struggled with providing the most effective processes for this core. My goal with this capstone is to determine if a centralized model is the most efficient and effective way of managing multiple INDs within the department.

History of clinical research regulations Over the past one hundred years, significant events within the field of clinical research have led to the development and implementation of regulations. This section will present an overview of significant events that led to the development of guidelines centered on Protection of Human Subjects and Investigational New Drugs applications.

The purpose of presenting this literature is to provide the reader with an understanding of the crucial events leading to regulations and processes within the field of clinical research. These events led to (and continue to) regulations concerning protection of human subjects and drug-related research.

The first event of significance for this capstone is the passing of the Pure Food and Drug Act in 1906. This law mandated all new drugs be tested for safety before marketing. The test results were required to be submitted to the Food and Drug Administration (FDA) as a New Drug Application (NDA). Unfortunately, this law did not prevent tragic events from occurring. In 1937, a drug company manufactured a strep throat treatment drug. The solvent included in this drug was poisonous, killing nearly one hundred people. It was discovered that the drug had not been tested in animals or humans before being marketed. This event became known as the Elixir Sulfanilamide tragedy (White-Junod, 2012). The Elixir Sulfanilamide tragedy led to the passing of the Food, Drug and Cosmetic Act of 1938. This law required peer-market review of safety in an NDA, and labeling requirements. In addition, this law provided the FDA with the ability to audit manufacturing organizations (White-Junod, 2012). “A new provision in the act -- requiring drug sponsors to submit safety data to FDA officials for evaluation prior to marketing -- appeared with relatively little discussion following on the heels of the Elixir Sulfanilamide disaster” (White-Junod, 2012). This statement stood out to me because the article did not specify who was involved in the decision-making process.

This raised some questions in my mind. Was there a thought out plan in place? Or was the act instituted as a knee jerk reaction? The government was liable because numerous deaths occurred and in order to demonstrate the problem was being fixed, a regulation was developed.

The Nuremberg Code is a regulation that was written in 1948 in response to the rights and welfare of human subject research participants and their mistreatment by Nazi Germany (Gordon & Prentice, 2000, p.1). “The origin of modern concern for the rights and welfare of human subjects participating in research is generally acknowledged to have occurred in December, 1946.” (Gordon & Prentice, 2000, p.1) Twenty-three individuals (physicians and administrators) were charged with murder and torture of humans for medical science. Between 1942 and 1945, thirty-two experiments were conducted on concentration camp prisoners. This code (see the HHS.gov website, http://www.hhs.gov/ohrp/archive/nurcode.html) consists of ten standards that must be met when conducting human subject related research (Table 1).

–  –  –

Code Code number 1 The voluntary consent of the human subject is absolutely essential.

2 The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3 The experiment should be so designed and based on the results of animal experimentation and knowledge of the natural history of the disease.

4 The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5 No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur.

6 The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7 Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8 The experiment should be conducted only by scientifically qualified persons.

9 During the course of the experiment the human subject should be at liberty to bring the experiment to an end.

10 During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Following the implementation of the Nuremberg Code came strong regulations specific to the drug industry. “In 1961, a popular drug in Europe, a hypnotic known as thalidomide, was discovered to cause severe birth defects and even death in babies when their mothers took the drug early in their pregnancies. Because of the concerns of FDA drug reviewer Dr. Frances Kelsey, the drug was never approved for sale in the U.S.

Nonetheless, the drug sponsor had sent samples of the drug to thousands of U.S. doctors who gave the samples to their patients without telling them that the drug was an experimental one, making their patients the unwitting subjects of human drug experimentation” (White-Junod, 2012). This event led to the Kefauver-Harris amendments of 1962, which mandated all drugs must be proven safe and effective before marketing. This was the underlying foundation for INDs.

In 1964, the World Medical Association (WMA) published the Declaration of Helsinki. This document describes ethical principles of conducting research involving humans. Gordon and Prentice (2000) state the document breaks medical research into two categories: clinical research combined with professional care, and non-therapeutic clinical research. This document was built upon the Nuremberg Codes as many American Physicians raised concerns about learning from “barbaric” events (Gordon & Prentice, 2000).

The Tuskegee Syphilis Study was conducted between 1932 and 1972. This is a widely publicized study, which led to further regulations within the field of clinical research. In the mid-1920s, a health initiative was started within the black community for which the Rosenwald fund provided monetary support to investigate treatment options for the disease of syphilis. The standard treatments were salvarsan, mercurial and bismuth, which in turn showed minor advantages and high toxicity. The fall of the stock market and Great Depression caused the Rosenwald fund to cut support.



Pages:   || 2 | 3 | 4 | 5 |   ...   | 11 |


Similar works:

«Douglas and Stemerding Life Sciences, Society and Policy 2014, 10:6 http://www.lsspjournal.com/content/10/1/6 RESEARCH ARTICLE Open Access Challenges for the European governance of synthetic biology for human health Conor MW Douglas1,2* and Dirk Stemerding1 * Correspondence: Abstract conor.douglas@ubc.ca Technology Assessment, Rathenau Synthetic biology is a series of scientific and technological practices involved in the Institute, The Hague, 2593 HW, The application of engineering principles...»

«Integrating the Healthcare Enterprise IHE Eye Care (EYECARE) Technical Framework Volume 1 IHE EYECARE TF-1 Profiles Revision 4.0 Final Text June 14, 2016 25 Please verify you have the most recent version of this document, which is published here. IHE Eye Care Technical Framework, Volume 1 (EYECARE TF-1): Profiles CONTENTS 1 Introduction 30 1.1 Introduction to IHE 1.2 Introduction to IHE Eye Care (EYECARE) 1.3 Intended Audience 1.4 Pre-requisites and Reference Material 1.4.1 Actor Descriptions...»

«May 2012 Am I old enough? Common legal issues for young people This booklet covers what you can and can’t do because of your age Am I old enough? Common legal issues for young people Do you need this booklet in a different format? Please ring us on 9269 0223 so we can talk with you about what you need. Produced by Victoria Legal Aid Victoria Legal Aid 350 Queen St Melbourne VIC 3000 Telephone 9269 0120 or country callers 1800 677 402 www.legalaid.vic.gov.au First published 1999 Twenty-first...»

«Effects of the Fukushima nuclear meltdowns on environment and health March 9th, 2012 Dr. med. Alex Rosen, University Clinic Düsseldorf, Department of General Pediatrics Abstract th The Tōhoku earthquake on March 11, 2011 led to multiple nuclear meltdowns in the reactors of the Fukushima Daiichi nuclear power plant in Northern Japan. Radioactive emissions from the plant caused widespread radioactive contamination of the entire region. The vast majority of the nuclear fallout occurred over the...»

«************************************************************ Powers of Homeopathy Newsletter Copyright 2004, Written and Published by Donna Powers, RCSHom, CCH, RSHom http://www.powersofhomeopathy.com Volume 1, Issue 5, October 19, 2004 Welcome! And to all who have just joined as readers, welcome! I love the technology of computers and cyberspace! To be able to share my love of homeopathy with so many readers this way is a thrill. I thank/bless each and every one of you who subscribe and read...»

«FACTORS ASSOCIATED WITH OCCURRENCE AND EARLY DETECTION OF PRESSURE ULCERS FOLLOWING TRAUMATIC SPINAL CORD INJURY by Shilpa Krishnan Bachelors in Physiotherapy, D.Y Patil University, 2009 M.S. Health and Rehabilitation Science, University of Pittsburgh, 2010 Submitted to the Graduate Faculty of School of Health and Rehabilitation Sciences in partial fulfillment of the requirements of the degree of Doctor of Philosophy University of Pittsburgh 2014 UNIVERSITY OF PITTSBURGH UNIVERSITY OF...»

«TECHNIQUE OF THE QUARTER DEVELOPING HEALTHY RECIPES AND MENUS Nutritious recipes are the foundation of a healthy menu. Before you take the time to develop new recipes, take a look at the dishes you already offer. Chances are that some of the recipes on your current menu already are healthy ones; other recipes might need some tweaking, and some might not work at all.READING A RECIPE FOR NUTRITION The first step in evaluating a recipe for a healthy menu is to know how you and your customers are...»

«HUMAN COMMUNICATION research Human Communication Research ISSN 0360-3989 ORIGINAL ARTICLE Sex Workers and HIV/AIDS: Analyzing Participatory Culture-Centered Health Communication Strategies Ambar Basu1 & Mohan J. Dutta2 1 Department of Communication, University of South Florida, Tampa, FL 33620 2 Department of Communication, Purdue University, West Lafayette, IN 47906 An emerging trend in health communication research advocates the need to foreground articulations of health by participants who...»

«JBC Papers in Press. Published on May 16, 2001 as Manuscript M103092200 Segev et al., Page 1 Müllerian Inhibiting Substance Regulates NFkB Signaling and Growth of Mammary Epithelial Cells Dorry L. Segev, Yasunori Hoshiya, Antonia E. Stephen, Makiko Hoshiya, Trinh T. Tran, David T. MacLaughlin, Patricia K. Donahoe and Shyamala Maheswaran Pediatric Surgical Research Laboratories, Massachusetts General Hospital and Harvard Medical Downloaded from http://www.jbc.org/ by guest on November 26, 2016...»

«Oxfam’s response to the Ghana National Health Insurance Authority’s criticisms of joint NGO report: ‘Achieving a Shared Goal: Free Universal Health Care in Ghana’ 25 March 2011 On 9th March a joint NGO paper was launched calling for free health care for all in Ghana and critiquing the Ghana National Health Insurance Scheme (NHIS) as an inefficient and unfair barrier to achieving this goal. The paper welcomed the strong political commitment of the Government of Ghana to health but called...»

«Ways to Improve (Visual) Outcome in Corneal Transplantation, Corneal Pathology and Astigmatism Marjolijn C. Bartels Financial support for the publication of this thesis by Prof.dr. Henkes Stichting, Rotterdamse Vereniging Blindenbelangen, Stichting voor Ooglijders, Alcon Nederland BV, Allergan BV, Bausch & Lomb, Laméris Ootech BV, Medical Workshop BV, MSD Nederland, Novartis Pharma BV, Oculenti BV, Ophtec BV and Pfizer BV is gratefully acknowledged. Cover: Natural keratoscopes, Etosha,...»

«AAA Adolescents & Adults with Autism A Study of Family Caregiving Report #8 An Inside Perspective from Adolescents and Adults with an Autism Spectrum Disorder Principal Investigators Marsha Mailick Seltzer, Ph.D. Waisman Center University of Wisconsin – Madison Gael Orsmond, Ph.D. Sargent College of Health and Rehabilitation Sciences Boston University Acknowledgements This project is supported by a grant from the National Institute on Aging (R01 AG08768). We gratefully acknowledge the support...»





 
<<  HOME   |    CONTACTS
2016 www.dissertation.xlibx.info - Dissertations, online materials

Materials of this site are available for review, all rights belong to their respective owners.
If you do not agree with the fact that your material is placed on this site, please, email us, we will within 1-2 business days delete him.