budget cuts affect recruitment and retention in medical research
What is Paul Theroux’s primary complaint about being a man today in
August 7, 2017Book is The Effective Executive
August 7, 2017Issue: professors said need to change the business problem which is – how budget cuts affect recruitment and retention in medical research
Issue: I need you to make my research question esoteric to business and create a problem or model I can solve
Issue: make it a qualitative study
Attachment
How does the lack of Government funding affect the business of medical research?
by
Mya Renderos
M.S., Walden University, 2012
B.S., California State University Los Angeles, 2009
Doctoral Study Submitted in Partial Fulfillment
of the Requirements for the Degree of
Doctor of Business Administration
Walden University
May 2015
Walden University
May 2015
Abstract
Insert abstract here; it should be no more than one page. Abstract text must be double-spaced with no paragraph breaks. Describe the overall research problem being addressed in the first couple of sentences and indicate why it is important (e.g., who would care if the problem is solved). You can include a general introduction of the issue in the first sentence, but you need to move to a clear statement of the research problem being addressed. Identify the purpose and theoretical foundations, if appropriate, summarize the key research question(s), and briefly describe the overall research design, methods and data analytic procedures. Identify the key results, 1 or 2 conclusions, and recommendations that capture the heart of the research. Conclude with a statement on the implications for positive social change. Here are some form and style tips: (a) Limit the abstract to one typed page; (b) maintain the scholarly language used throughout the doctoral study; (c) keep the abstract concise, accurate, and readable; (d) use correct English; (e) ensure each sentence adds value to the reader’s understanding of the research; and (f) use the full name of any acronym and include the acronym in parentheses. Do not include references or citations in the abstract. Per APA style, unless at the start of a sentence, use numerals in the abstract.
Abstract
Implementation is the critical gateway between the decisions to adopt the Continuous Quality Improvement (CQI) innovation and the routine use of CQI innovation or integration of a new idea or practice into the operating system of the organization (Burns, Bradley & Weiner, 2012). For decades models have been implemented and reinvented to improve recruitment and retention in clinical research. In order to manage clinical trials, no matter the size and intricacy, necessitates well-organized management. Trials fail because there aren’t any published documentation to guide new medical research professionals on how to succeed in the clinical field and what approach may not work with the changing economy. I suggest in order to improve clinical trials that will successfully retain patients, a standard guideline must be developed and implemented by all trialists for the benefit of our patients and future studies. Clinical trials could succeed with the implementation of a businesslike approach to their management.
EXAMPLE OF WHAT TO ADD TO THE ABSTRACT. DISCUSS METHODS USED FOR STUDY
An analysis of 114 multicentre trials funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) and UK Medical Research Council (MRC), STEPS [3], showed that 45% failed to reach 80% of the prespecified sample size. Less than one third of the trials recruited their original target number of participants within the time originally specified, and around one third had to be extended in time and resources. One factor observed in trials that recruited successfully was that they had employed a dedicated trial manager (odds ratio: 3.80, 95% CI: 0.79 to 36.14; P = 0.087). The STEPS collaborators suggest that anyone undertaking trials should think about the different needs at different phases in the life of a trial and put greater emphasis on ‘conduct’ (the process of actually doing trials) [3]. In addition, the MRC acknowledged that the failure of some trials can be due to practical problems with trial management rather than scientific problems or problems with the trial design [4]. Francis et al. [3] examined whether clinical trials could be considered from a business management perspective and proposed that the dimensions of running a successful trial includes ‘marketing’, ‘sales’ and ‘ongoing client management’. They recognised that in the recruitment stage of a randomised controlled trial (RCT), the most demanding activity is to establish and implement a range of effective management techniques which parallel those used to run a successful business.
How does the lack of Government funding affect the business of medical research?
by
Mya Stringer Renderos
M.S., Walden University, 2012
B.S., California State University Los Angeles, 2009
Doctoral Study Submitted in Partial Fulfillment
of the Requirements for the Degree of
Doctor of Business Administration
Walden University
May 2015
Dedication
I dedicate this research to my parents, my siblings, Grandma Gail and Christ. Through this journey you all have supported my vision and I am grateful. Lord, you have kept my mind sound and given me great strength and comfort. My faith in you is what kept me going and I dedicate my all to you. To my best friend, Tiffany Turner-Dukes, I thank you for every laughter and tears we shared. Through every frustration you were there every step of the way. I love you all. Thank you!
Acknowledgments
I would like to acknowledge, Walden University, my academic advisor Ann S, my committee, Dr. Heyliger, Dr. Robert Hockin, and Dr. Tom Schaefffer. I thank you for your support, for your direction and your wisdom. I thank God for all of you because you helped shape me into the Doctor I am today and because of you I am a better writer. I would like to thank Dr. Ron Hays, Dan Sfera and …… for your help in my interview. I look up to you and I appreciate your mentorship. I pray I can only accomplish as much as you have. You are men of excellence and I am blessed to have learned from you.
Acknowledge Dr. Gossett Anne Stepchuck
Table of Contents
List of Tables. iv
List of Figures. v
Section 1: Foundation of the Study. 1
Background of the Problem.. 1
Problem Statement 1
Purpose Statement 2
Nature of the Study. 3
Research Question. 3
Hypotheses. 4
Interview/Survey Questions. 4
Theoretical or Conceptual Framework. 4
Definition of Terms. 4
Assumptions, Limitations, and Delimitations. 5
Assumptions. 5
Limitations. 5
Delimitations. 5
Significance of the Study. 5
Contribution to Business Practice. 5
Implications for Social Change. 5
A Review of the Professional and Academic Literature. 6
Transition and Summary. 7
Section 2: The Project 8
Purpose Statement 8
Role of the Researcher 8
Participants. 8
Research Method and Design. 8
Method. 9
Research Design. 9
Population and Sampling. 9
Ethical Research. 10
Data Collection. 10
Instruments. 10
Data Collection Technique. 11
Data Organization Techniques. 11
Data Analysis Technique. 12
Reliability and Validity. 12
Reliability. 12
Validity. 12
Transition and Summary. 12
Section 3: Application to Professional Practice and Implications for Change. 13
Overview of Study. 13
Presentation of the Findings. 13
Applications to Professional Practice. 13
Implications for Social Change. 14
Recommendations for Action. 14
Recommendations for Further Study. 14
Reflections. 14
Summary and Study Conclusions. 14
References. 15
Appendix A: Title of Appendix. 17
Curriculum Vitae. 18
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List of Tables
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List of Figures
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Section 1: Foundation of the Study
Text begins here. Provide an overview of the context or background of the problem. DBA Doctoral Studies are focused on applied business research
Section 1: Foundation of the Study
Background of the Problem
For many decades the federal government and private funders have been the sources of medical research. According to the National Institute of Health (NIH) (2013) on March 1, 2013, as required by statute, President Obama signed an order initiating sequestration. Sequestration is a process where the United States Federal Government automatically cuts budgets. The NIH was required to cut 5 percent or $1.55 billion of its fiscal year (FY) 2013 budget (NIH, 2013). This budget cut affected many programs, projects, and activities (PPAs), which are under the NIH institutes and centers. Medical research has affected by sequestration.
Problem Statement
The NIH is the largest source of funding for medical research, distributing more than $30 billion per year for research. More than 83 percent of the NIH budget goes to more than 300,000 research personnel at over 3,000 universities, medical schools, and other research institutions in every state and throughout the world (Richardson, 2013). The 16-day government shutdown that went into effect in 2013 required scientists to suspend work on research projects while Congress delegated about the U.S. budget. If studies cannot increase patient recruitment and retain them, then the studies will not receive profit. Clinical Trials are suggested to be the greatest level of evidence for guiding clinical practice. However, how to manage clinical trials is not a major topic in many commentaries. The subject and financial resources for successfully conducting clinical trials is finite, it is imperative to make sure that randomized clinical trials are structured and well managed. Well managed clinical trials are securely invested in by subjects, time and money. Clinical trials warrant expert management and needs to be managed from its inception like any other business (Farrell, Kenyon & Shakur, 2010).
Purpose Statement
The purpose of this exploratory qualitative study is to identify strategies that research managers can use related to patient recruitment and retention issues. The perceptions of healthcare professionals related to conducting medical research in the face of uncertain funding will be explored by interviewing managers with experience with these problems. Twelve managers will be interviewed with semi structured open ended questions to determine the effect the sequestration had on patient recruitment and retention issues in a medical research facility in Los Angeles, California. This study seeks to provide information suitable strategies that will help future researchers facing government budget constraints. Organizations must be able to adapt in order to sustain and prosper in tough economic situations (Malik & Usman, 2011). The findings from this study might contribute to social change by providing information that will improve patient recruitment and increase patient retention when facing constraints from government support of research.
Nature of the Study
Recruitment of a significant number in clinical trials is a challenge when using human participants. The study will help local researchers develop strategies to overcome the challenges faced in recruiting and retaining study participants. Kremidas suggested (2011) expertise regarding how best to implement some of the necessary activities for successful patient recruitment is available through sponsors/CROs and should be utilized, he noted (2011) most effective sites work collaboratively with experts and adapt patient recruitment methods to fit their environment.
A challenge which needs to be addressed is that companies are not able to balance recruitment and retention. Recruitment rates may be high at times but retention may not be. Focusing on bringing awareness, balance, and funding options can improve patient recruitment and retention. Cutting Edge Information (2014) statistically found that only 36 percent of large pharmaceutical companies use formal patient retention strategies. Companies do not invest in patient recruitment budgets. In order to see profit in clinical trials, to convince stakeholders to continually invest in studies, studies must invest in recruitment budget. Development teams can provide tools for overcoming recruitment and retention issues. Once these issues are addressed profit will increase and Government funding will no longer be a primary entity for budget.
Research Question
The central research question for this study is to identify what strategies can be used to address recruitment and retention issues for patients when budget cuts are made that could negatively affect clinical trials.
Central Research Question
1. Do clinical trials fail because of the lack of a structured foundation and concrete business approaches to managing trials?
Sub-Question
2. Is the lack of government funding one of the causing factors that affect the business of medical research?
Interview Questions
What does it mean to be a medical researcher?
1. Will you please explain what a medical researcher is?
2. What is the most difficult part about being a medical researcher?
3. What is your role in your profession as ___________________?
According to The White House (2013) in the last few years, President Obama and both parties in Congress have worked together to reduce our deficit by more than $2.5 trillion through a combination of spending cuts and increased tax rates. In 2011, Congress passed a law saying that if they couldn’t agree on a plan to reduce our deficit by $4 trillion — including the $2.5 trillion in deficit reduction lawmakers in both parties have already accomplished over the last few years — about $1 trillion in automatic, arbitrary and across the board budget cuts would start to take effect in 2013 (The White House, 2013). Sequester has put our military, education, energy and medical research in jeopardy.
4. How do you feel about the sequester budget cut that was took effect March 1, 2013? Would you say sequester helped or harmed the economy?
5. In your experience, how has budget cuts in medical research affected your business?
6. What are the consequences for the next generation of researchers in the years to come if budget does not increase?
7. What are some examples of what takes place when a research site is forced to shut down?
8. You stated that, “_________________”, takes place when a research site is forced to shut down. How does this affect recruitment? How does this affect retention?
Wrap-up Questions
9. What advice do you have for research sites that are forced to close after there is no more funding?
10. What advice do you have for me and other upcoming researchers?
Theoretical/Conceptual Framework
Challenges in patient recruitment and retention are considered the major cause of drug development delays, but start-up activities are key factors as well, particularly issues around site contract and budget negotiations and approval (Schimanski, Carolann, & Kieronski, 2013). To narrow disparities in health care in the U.S., it is essential that research studies include women and minorities (Glast et al., 2013). Pauly et al. (2012) suggest that there is a need to identify priorities to guide future research on recruitment and retention strategies in health care. A qualitative approach can provide insights about recruitment and retention (Adezei & Atinga, 2012). This project will utilize Frederick Herzberg’s (1959) two-factor content theory to understand the attitudes and motivation of medical researchers after the budget cuts. Herzberg was a well- respected American who contributed greatly to the way in which managers think about motivation at work (TDS, 2014). His theory focuses on how satisfaction of needs and desires are major determinates of individual behavior at work (TDS, 2014). To narrow healthcare disparities in the U.S., it is important to include women and increase minority participation in clinical research (Glast, Huang, Rawal, Harvey, Entrane, & Jamerson, 2013). Challenges in patient recruitment and retention are considered the major cause of drug development delays, but start-up activities are key factors as well, particularly issues around site contract and budget negotiations and approval (Schimanski, Carolann, & Kieronski, 2013).
Definition of Terms
Beneficiary: An individual with the right to receive medical care and who receives such care (Aldhizer, 2009).
Double billing: A fraudulent billing practice that involves a practitioner or health care services organization submitting a bill for the same procedure on different dates (Phillipsen, Setlow, & Jacob, 2008).
Clinical Trials:
Continuous Quality Improvement (CQI): Focuses on the use of generic analytic techniques that facilitate improvement of both clinical and nonclinical processes; CQI is characterized by its encouragement of managerial reforms that are designed to bring about organizational change (Burns, Bradley & Weiner).
Contract Research Organization CRO:
Fiscal FY:
National Institute of Health:
Open ended interview:
Programs, Projects, and Activities (PPAs):
Recruitment:
Retention:
Semi Structured Interview:
Assumptions, Limitations, and Delimitations Assumptions
Significance of the Study
Contribution to Business Practice
Patient recruitment plays a major role in establishing the objectives and the ultimate success of clinical trials. Yet, targeting the right patients and retaining their participation is one of the greatest challenges currently facing the biopharmaceutical industry (Kremidas, 2011). In order to positively affect social change, health care leaders indeed have the power to make a great difference in medicine. Patient recruitment plays a major role in establishing the objectives and the ultimate success of clinical trials (Kremidas, 2011) yet, targeting the right patients and retaining their participation is one of the greatest challenges currently facing the biopharmaceutical industry.
On a local or global scale enforcing health care promotion would be a good start to promote awareness of changes being made and getting the community involved to makes changes. The study is important because it examines ways in which the federal government can change a system in which the cost fails to justify the means. Billions of dollars are spent annually to essentially warehouse people who break the law. At its current rate, coupled with the condition of the U.S. economy, the prison system is not sustainable, nor does it provide a true return on investment.
Implications for Social Change
Sequestration is an action implemented by the Government which caused an effect on a group of individuals with shared value or a shared characteristic. The target group that have a goal of positive social change within the medical community are usually liberal and democratic parties (depending on perspective), elderly, poor and middle class citizens of America, or major and/or start-up health care organizations. According t
