Day 1 :
Keynote Forum
Ballari Sen
University at Buffalo, NY 14214, USA
Keynote: Utilizing SAS Macros for Laboratory Data Standardization of clinical trial data in Data Management
Time : 10:50
Biography:
Ballari has completed her Bachelor’s of Enginnering in Biotechnology from Dayananda Sagar college of Engineering, and currently graduating in May 2019,from Univeristy at Buffalo with a MS in Biomedical Engineering. Having 3+ years of experience as a clinical SAS Programmer with HCL Technologies,generating SAS Programs to analyze data,creation of reports-tables,listings and graphs. Experience in developng & validating CDISC SDTM datasets from raw data and analysis data sets – AdaM format from SDTM datasets.Also,Currently interning as a SDTM specialist & clinical SAS programmer intern at Frontier science & Technology Research Foundation.
Abstract:
Efficiently handling Clinical Trial Data based on the Clinical Data Interchange Standards Consortium(CDISC) standard,the regulatory rules from U.S. Food and Drug Administration (FDA) and electronic data submission requirements is very important for Drug Development.
The laboratory dataset is one of the core safety datasets and converting the incoming lab data into a submission–ready format is often challenging and stressful to the programmer. Laboratory data usually come from central laboratories and/or many different local laboratories. Different laboratories usually have different original reported laboratory test names, units and reference ranges. In order to pool and analyze these reported data efficiently and correctly, central/local laboratory test names, units and results must be converted to a standard format.
Thus any work we do for lab data can easily get long and tedious unless we can find a way to standardize or macrotize it.Further, SAS Macros presents a conceptual programming code to maximize the efficiency and avoid tedious repetitive tasks by creating a set of SDTM generation macros and providing all the required study specific information via the SAS co`de.
This poster presentation, focuses on one of the common lab analysis needs – converting lab test results from one unit into another. I begin by describing why it is necessary to perform unit conversions. I then describe some purely SAS - based approaches, since, as SAS programmers, this is typically how we tackle a project. Finally, I explore processes that make use of SAS Macros,to convert the clinical Lab data to standard format of Standard data tabulation model.
- Clinical Research & Clinical Trials: Academic Perspective
Location: Atlanta, USA
Session Introduction
Dr. Sedegheh Malek Mohammadi
Orthotics and Prosthetics research clinic, Iran
Title: Measure of the plantar fascia thickness and the amount of the applied vertical load in rehabilitation
Biography:
I am faculty of orthotics and prosthetics. My experience in the research of orthotics and prosthetics, teaching in University, clinical experiments and measuring is more than 25 years. I have done research in the area of plantar fascia qualities and its connection with the ankle and foot structure and function in living individual. (My PhD) I have experience of working with Ultrasound machine. I have presented my papers in international congresses, conferences and symposiums since 2004. Some of my papers have been published, also. I have written five books in the area of orthotics and prosthetics in Persian. Additionally, I have been chief guest editor in the American Journal of Medical Sciences and Medicine (Special Issue) up to March 01; 2015. I have been guest editor in the American Journal of Sport Science and Medicine (Special Issue) up to April 10, 2018
Abstract:
The objective of this research is controlling the vertical load applied on the foot in static and locomotion in living individual. Plantar fascia has long been connected to the kinematics and kinetics qualities of the ankle and foot. It is believed quantified plantar fascia thickness is a location to quantify the amount of the applied load. It has been accepted that thickness of the plantar fascia is different not only along its length, but also in equivalent locations in both feet. Method; 1) plan of investigation was designed based on six landmarks and three reference lines to identify the location of the plantar fascia along its length, 2) thickness of the plantar fascia was scanned through Ultra Sound 2D measuring before modification. Plantar fascia thickness was scanned in sagittal and frontal planes to be quantified with Image J software, 3) pressure markers were put on identified locations of the plantar fascia. The amount of the applied pressure was assessed with E-med, in static and locomotion, 4) Qualysis, The percentage of the body weight was calculated in identified locations. Data was collected simultaneously through Emed and Qualysis in static and locomotion. It was found that quantifying the amount of the applied load in identified location of the plantar fascia is achievable, individually. The outcome of quantitative information of an individual with 65 Kg weight was; plantar fascia thickness [(1.1 ± 0.6mm) < longitudinally > (1.4 ± 0.2mm) and (1.2 ± 0.6mm) < transversely > (1.4 ± 0.2mm)], [ (41.3 ± 4.5) < applied pressure on the plantar fascia > (79.3 ± 17.5)] ,[(0.6% ± 0.18%) <the percentage of the body weight in identified location of the plantar fascia > (1.1% ± 0.27%)]. Appropriately, prevention of injury and rehabilitation schedule can be achievable according to the biological qualities of the movements.
- Clinical Data Management and Analytics
Location: Atlanta, USA
Session Introduction
Susu M. Zughaier
College of Medicine, Qatar University, Doha, Qatar P.O. Box 2731
Title: Vitamin D Status Association with Monocyte Percentage to HDL (MHR) as biomarker to predict dyslipidemia among Young Healthy Qatari Cohort
Biography:
Susu Zughaier, Associate Professor of Microbiology and Immunology at Qatar University. Trained as a clinical microbiologist, University College London; MSc in Medical Microbiology and PhD in Microbiology and Immunology from Cardiff University, UK. She did her postdoctoral training at Harvard Medical School in Boston, USA. Dr. Zughaier was an Assistant Professor at the Emory University School of Medicine in Atlanta, USA. Her research interests are focused on host-pathogen interactions and vaccine development. Her translational research is focused on vitamin D immune modulatory effects. She published reputable journals and awarded two patents. She serves as the Scientific Microbiology Councilor for the International Endotoxin and Innate Immunity Society.
Abstract:
Vitamin D insufficiency and deficiency are highly prevalent in Qatar and are associated with metabolic syndrome. Low vitamin D status is associated with altered lipid profile characterized by reduced HDL. Monocytes play an important role in host defense as they secrete inflammatory cytokines and in cholesterol metabolism as well. The aim of this study is to investigate the unknown association of vitamin D status with monocyte percentage to HDL (MHR) among healthy Qatari population. In a cross-sectional study that included a cohort of 874 subjects, Qatar Biobank data was utilized to retrospectively investigate the association between vitamin D levels and the following lipid metabolism related parameter: monocyte percentage, HDL, LDL, TG, total cholesterol, uric acid, vitamin B12, estrogen, testosterone and BMI in Qatari young healthy adults.
Within the cohort, vitamin D status was as follows: 74 subjects were sufficient, 400 subjects were insufficient and 400 subjects were deficient. Vitamin D deficiency was significantly associated with monocyte percentage (P = 0.01), estrogen (P = 0.036), and vitamin B12 (P < 0.001) after adjusting for age and gender. Using continuous analysis, monocyte percentage was inversely associated with vitamin D (P = 0.002, correlation coefficient = -0.5) and HDL (P = 0.003, correlation coefficient = -0.02) levels. However, monocyte percentage was strongly and positively associated with uric acid (P < 0.0001, correlation coefficient = 6.03), and testosterone (P < 0.000, correlation coefficient = 1.07) levels. Taken together, the data suggest that monocyte to HDL (MHR) is associated with vitamin D status and could be a useful marker to predict inflammation associated with dyslipidemia.
- Enrollment Planning and Patient Recruitment
Location: Atlanta, USA
Session Introduction
Dominique Guinn
Texas Woman’s University
Title: Engaging Ethnic Minorities In Clinical Trials
Biography:
Dominique Guinn, a cancer survivor and clinical trial participant completed her PhD in May of 2019 from Texas Woman’s University. She is a Visiting Professor at Texas Southern University, in Houston, Texas. Terrance Adams is a Health Education Specialist at MD Anderson Cancer Center in Houston, Texas.
Abstract:
Within this literature review, this author will systematically identify and examine recent and relevant literature regarding barriers to minority participation in clinical trials. This literature review uses elements of Garrard’s Matrix Method and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The databases accessed to conduct this literature review were: (a) Medline/PubMed, (b) CINAHL, (c) Nursing- ProQuest Database, (d) Scopus, and (e) Google Scholar. Search terms included MeSH terms and Subject Headings where appropriate. The metanalysis identified barriers to participation in clinical trials by minorities. Mistrust of medical personnel because of unethical research conducted on African Americans, current and historical segregation, racism, and unjust treatment within the health care system were some of the barriers identified. Dr. Guinn is living with Acute Lymphoblastic Leukemia and a participant in clinical trials at MD Anderson Cancer Center. MD Anderson has outreach programs dedicated to promoting education and awareness around clinical trials to minorities in underserved communities. They have enlisted multiple strategies to recruit minorities using innovative approaches to break down invisible barriers and rebuild people trust in medicine. As a result of their efforts they have been able to increase minority participation in clinical trials.
- Future of Clinical Trials and Technology Innovations
Location: Atlanta, USA
Session Introduction
Praful Krishna
Founder and CEO of Coseer
Title: Natural Language Search for Faster Drug Development
Biography:
Praful Krishna, Founder of Coseer, helps Fortune 500s and Governments to automate tedious, repetitive text-based tasks. Coseer’s novel approach to NLS-based AI for enterprise has won numerous industry accolades, including “Best AI Application in Healthcare” at the 2018 AIConics awards. Praful founded Coseer after a career with a hedge fund and a turnaround CEO role. He is an alumnus of McKinsey, Harvard, and IIT.
Abstract:
The focus will be a case study of wildly successful NLS deployment at a top-tier pharmaceutical company. Drug development has never been more expensive or more complex, and pharma companies need better information faster without compromising user experience. Before NLS, our client’s Phase II clinical trial reporting took three months or more. Now, after NLS integration, reporting takes one month, and scientists are able to easily find 100% of information needed as opposed to just 54% with the legacy system. The benefits don’t stop at Phase II – NLS is poised to transform not just clinical trials but any wasteful pharma process. By giving scientists back time to focus on creating life-saving drugs, our customer was able to generate huge cost savings, optimize operations, and keep scientists happy. The relevant white paper may be referenced here: https://coseer.com/content/natural-language-search-for-faster-drug-development/