Medicine and Health Sciences Commons^™

Policy Analysis Of Foreign Trials Needed For Fda-Approved Inds For Devices And Drugs From 2016 To 2020, Rebekah Tilley

Master's Theses and Doctoral Dissertations

Any new drug or medical device requires testing before it can be commercialized. Although there are many paths a product can follow during preclinical testing to bringing it to the market, the need for multinational data is more necessary for drugs in comparison to medical devices. Since drugs do not always need additional data, there is a need to investigate why medical devices are more easily approved than drugs. The use of foreign data is fairly recent, and even though there are advantages to executing clinical trials in foreign countries, some companies do not want to run their studies outside …

Demographic Profiles Of Clinical Research Participants In Fda-Approved Nmes, Abayomi Oladoye Ojetayo

Master's Theses and Doctoral Dissertations

Drug development is a rigorous and expensive process that takes between 10 and15 years. Recruitment and retention of human subjects in clinical trials is challenging. This study collected the demographics of trial participant in trials for New Molecular Entities (NMEs) approved by the U.S. Food Drug Administration (FDA) for 2010 and 2020 to compare demographic representation. Demographic representation of trial participants for 61 FDA-approved NMEs for 2010 and 2020 were gathered; 21 NMEs were excluded from analysis. The trends in demographic representation in trials for the 40 FDA-approved NMEs in 2010 and 2020 were similar, and White participant representation was …

Health Outcomes For Low-Income Older Adults With Diabetes Who Receive Services From Meals On Wheels, Monyca Johnson

Senior Honors Theses and Projects

INTRODUCTION: As the population continues to age and healthcare costs steadily increase, identifying what factors possibly add to the risk of hospitalization will help find effective solutions targeting these issues. HYPOTHESIS: We hypothesized that Medicaid and Medicare dual eligibility, membership in a racial minority, and female gender would increase the risk of hospitalizations in the past year. We further hypothesized that receipt of food assistance would decrease the risk of hospitalization for older adults with diabetes. METHODS: For this study, we conducted a secondary analysis of data from the National Health and Aging Trends Study (NHA TS) to test the …

Reproducibility And Reliability Of Chromatin Immunoprecipitation In Clinical Research, Kelli Mcdonough

Master's Theses and Doctoral Dissertations

Association between histones and DNA is crucial for many cellular functions such as gene transcription and epigenetic silencing. Changes to chromatin structure influence gene expression via histone modifications. Chromatin immunoprecipitation (ChIP) is an experimental technique used to investigate the interactions between histones and DNA. ChIP determines the specific location in the genome that histone modifications are associated with, indicating the target of the histone modifiers. Despite the appeal of ChIP as an in vitro technique, there are limitations to its use. There is variability from one preparation to the next, given the many steps and reagents used throughout the technique. …

Designing A State-Of-The-Science, Accredited, Commercially-Successful Biorepository Utilizing Iso:9001(2008) Quality Management System Requirements To Construct The Framework, Kimberly S. Gonzalez

Master's Theses and Doctoral Dissertations

The research community relies upon biorepositories’ ability to prepare for the scientific advancement that can precipitate the discoveries of the future. Furthermore, as the complexities, financial pressure, and quality issues biorepositories face continue to unfold, it is imperative to explore unmet needs researchers may have for biorepository services as well as evaluate the commercial potential, funding, and competitiveness of a new biorepository. With the goal of contributing to medical and scientific research and the biorepository field, this paper utilizes principles from ISO 9001:2008 “Quality management systems- Requirements” to outline and explore the challenges in establishing a state-of-the-science, accredited, commercial BSL-2 …

Physician Satisfaction With Informed Consent Process In Psychiatric Research, Sushma Polavarapu

Master's Theses and Doctoral Dissertations

Informed consent process is crucial in any research. The consent is meaningful only when the subject is capable of using disclosed information in deciding whether to participate in a research study. Decision-making capacity might change in psychiatric patients during the informed consent process. Therefore, there may be some elements which are neglected during the informed consent process in psychiatric research. The purpose of this research study was to determine the perceptions of physicians about what elements of informed consent might be neglected in psychiatric research and what additional elements might be included that would improve the informed consent process for …

Pharmacovigilance: A Comparative Study About The Knowledge Of Adverse Drug Reaction (Adr) Reporting That Private Practitioners And Government Doctors Gained In A Random Locality In India, Shanthan B. Pingili

Master's Theses and Doctoral Dissertations

The present pilot study aims to compare the knowledge pertaining to ADR reporting systems that government doctors and private practitioners gained in a random, tier-II city in India, by conducting a questionnaire based survey. Their knowledge of ADR reporting, related guidelines and/or regulations, the frequency of ADRs they observe and diagnose, their opinion on mandatory reporting by doctors, type of ADRs they would generally report, and to whom ADRs should be reported are discussed besides evaluating the attributable reasons for underreporting, if any. A total of 47 (21.36%) responded to this random survey, of whom 27 (57.4%) were government doctors …

Role Of Nf-KB Signaling In Multiple Myeloma, Rachel Rajavi Pallapati

Master's Theses and Doctoral Dissertations

Genomic DNA was purified from Multiple Myeloma Cell Line JJN3, and BMF promoter region was PCR amplified and cloned into pCR 2.1 TOPO vector using One Shot® Chemically Competent E. coli. After confirmation of the clone through polymerase chain reaction (PCR) and restriction analysis, BMF promoter (2.5 Kb) was released from TOPO vector and subcloned into pGL3 promoter vector. The resulting pGL3-BMF-promoter vector was further amplified for MaxiPrep preparation. This plasmid can be used to study the regulation of BMF promoter by various transcription factors including NF-κB family members.

A Retrospective Study To Evaluate The Efficacy Of Trimethoprim/Sulfamethoxazole (Tmp/Smx) Compared To Daptomycin Or Linezolid For The Treatment Of Infections Due To Methicillin-Resistant Staphylococcus Aureus (Mrsa), Aparna Lakshmi Murari

Master's Theses and Doctoral Dissertations

Background: Staphylococcus aureus is still considered one of the most significant human pathogens in terms of morbidity, mortality, and costs. Vancomycin should be avoided if possible for the treatment of MRSA when the Minimum Inhibiting Concentration (MIC) to Vancomycin is 2μg/mL, as it poses a therapeutic challenge. Main therapeutic options include Daptomycin and Linezolid, two new, expensive drugs, and trimethoprim/sulfamethoxazole(TMP/SMX), an old, inexpensive agent. Study aims were to compare the clinical efficacy and potential cost savings associated with TMP/SMX use.

Methods: A retrospective study was conducted at Detroit Medical Center. For calendar year 2009, unique adult patients (>18 years) …

Influence Of Clinical Research Investigator Fraud On Clinical Trial Participation, Purnachandra Garimella

Master's Theses and Doctoral Dissertations

The number of clinical research investigators whom the Food and Drug Administration (FDA) has disqualified or totally restricted has been increasing since 1964. In addition, several public polls and surveys indicate a major dilemma in clinical trial participation and public perceptions of clinical research. This research investigates how clinical investigator fraud or misconduct influences public perceptions of participation in clinical trials. To meet this challenge, a welldesigned electronic survey was developed for the faculty at Eastern Michigan University (EMU). The survey results indicate that 79% of respondents were ―very likely‖ to be influenced by fraud committed by their own physicians. …

Cultural Determinants Affect Implementation Of Good Clinical Practice (Gcp) In Human Research Studies In Malawi, Africa, Joann Jeanne Schmidt

Master's Theses and Doctoral Dissertations

Clinical research conduct and Good Clinical Practice (GCP) implementation are influenced by local culture. This study examines the experiences of 26 clinical research personnel in Malawi, Africa, in order to define relevant issues, identify solutions, and give voice to local investigators. Qualitative, semi-structured interviews were conducted, audio-recorded, transcribed, and analyzed. Six themes, related to cultural determinants, emerged: 1) communitybased decision-making, 2) illiteracy, 3) patient identifiers, 4) local myths and misconceptions, 5) poverty and disease, and 6) barriers to teamwork. Findings revealed that: 1) Malawians are best at identifying local solutions, 2) operations research is needed 3) greater networking and communication …

Outcomes Of Patients Transferred To The University Of Michigan Health System On A Short-Term Ventricular Assist Device For Cardiogenic Shock, Christina L. Leventhal

Master's Theses and Doctoral Dissertations

Short-term ventricular assist devices (VADs) are mechanical pumps that are used to temporarily support a patient who is in cardiogenic shock. These VADs are effective in sustaining a patient’s life until he or she can been transferred to a tertiary cardiac center such as the University of Michigan Health System. The researcher examined patients’ clinical status at the time of transfer and used univariate analysis to determine which factors are likely to predict a successful outcome. Multivariate analysis showed that younger age and better kidney function were prognostic variables in the patients’ 30-day and long-term survival. These factors improve the …

Serum Gamma-Glutamyltransferase And The Risk Of Type 2 Diabetes In A Population-Based Cohort Study Of Older Mexican Americans, Lynn Blythe

Master's Theses and Doctoral Dissertations

Our objective was to test the hypothesis that increased GGT predicts an increased risk of type 2 diabetes (T2D) in elderly Mexican Americans.

Data from a population-based cohort study of 1789 community-dwelling Mexican American men and women, aged 60-101, in the SALSA study were used. Data for 1,203 participants without diabetes at baseline were evaluated for incident diabetes. Proportional hazard models were used to predict the probability of incident T2D by GGT level.

After adjustment for age, gender, smoking, alcohol use, and BMI, the risk of developing T2D associated with GGT was significant at 1.4 (95% CI 1.2 -1.7). However, …

Approval Of New Drugs By The U. S. Food And Drug Administration: Problems With The Process And Access To Unapproved Drugs, Christine M. Hoeft-Loyer

Master's Theses and Doctoral Dissertations

Today, the vast majority of drugs available for patient use have gone through a rigorous system of human clinical trials supervised by the Food and Drug Administration (FDA), to ensure the drugs are safe and efficacious. There are now citizen advocacy groups that seek use of drugs not yet approved by the FDA, to be administered to terminally ill patients who have exhausted all other available means of therapy. The FDA has programs for terminal patients, under the supervision of their physicians, to use unapproved drugs; however, the advocacy groups seek access to drugs in much earlier phases than is …

Identification Of Symptom Domains In Ulcerative Colitis That Occur Frequently During Flares And Are Responsive To Changes In Disease Activity, Tahira M. Khan

Master's Theses and Doctoral Dissertations

The aim of this study was to determine which symptom domains in ulcerative colitis (UC) are important in the evaluation of disease activity. An important symptom is that which 1) occurs during flares, 2) improves during effective therapy, and 3) resolves during remission. Twenty eight symptom domains were evaluated. Sixty subjects were surveyed, rating each symptom on three criteria with a 100 mm Visual Analog Scale (VAS). Important symptoms were defined a priori as those whose median VAS rating for all 3 criteria was significantly greater than 50. Thirteen of the 28 symptom domains proved to be both frequent in …

The Effects Of Variable Practice And Subjective Estimation On Error-Detection Capabilities, Colleen E. Donakowski

Master's Theses and Doctoral Dissertations

Retention and transfer for ballistic open motor skills may best be achieved through specific + variable practice along with error estimation. Inconsistent support for the variability of practice hypothesis warrants a cross-testing of this hypothesis. Estimation had been used and found beneficial on ballistic closed motor skills, but what about ballistic open motor skills?

This study tests ballistic open motor skills on an anticipation timer. Specific and specific + variable practice groups coupled estimation and no-estimation conditions for testing purposes.

The results indicated that although there were no significant differences during acquisition, significant differences did exist for retention and transfer …