Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 5th World Congress on Advanced Clinical Trials and Clinical Research Melbourne, Australia.

Day 1 :

Keynote Forum

Nagham Ramzi Sheblak

King Abdullah International Medical Research Center (KAIMRC)-KSA, Riyadh Saudi Arabia

Keynote: The Challenges In Conducting Research Studies In Arabic Countries
Conference Series Clinical Trials Congress 2020 International Conference Keynote Speaker Nagham Ramzi Sheblak photo
Biography:

Nagham Ramzi Sheblak is an Certified as Clinical Research Pharmacist-CCRPh Mar.2019, Canadian Association of Clinical Research Specialist-Canada has the work experience Prince Nourah bint Abdulrahman University & also Monitors the developments of research studies by ensuring proper initiation and follow-ups process with the Principal Investigators in the year 2011-2018 National Guard Health Affairs - Oncology Department, In 2006 [EXECUTIVE MANAGER - FEMALE SECTION] Providing high quality and applicable health related consultations via effective persons who have access to the resources supported by all the experts of the health field all over the Kingdom. Help in designing database, office brochure and announcements.

 

 

Abstract:

The fraction of patients participating in clinical research studies has been relatively low and declined further in recent years, and many barriers are facing healthcare providers in conducting such studies. Our aim in this study is to identify common barriers facing our healthcare providers to conduct clinical trials in those patients in the MENA region. Methods: A qualitative study was carried out between July 2014 and April 2015 where the semistructuredsurveywas conducted usingSurveyMonkey softwaretoall healthcare providers who work in seven different domain areas (physicians, pharmacists, nurses, clinical research associates, clinical research coordinators, auditors, and IRB members and data entry clerks). Results: Of 329 responders from 7 specialties, the majority [183 (55.62%)] were males and 193 (58.66%) from Saudi Arabia. Physicians and pharmacists represent the majority [155 (47.11%) and 76 (23.10%)] of the total group, respectively, and the least were nurses and auditors [5 (1.52%) in each]. The highest rate barrier reported by physicians and pharmacists was inadequate training in clinical research implementation [76 (23.1%)], while clinical research coordinator reported the same barrier in 18 (5.5%). Clinical research associates reported a lack of incentive and credit for research work in 17 (5.2%). Reviewers reported a lack of leadership support and lack of financial grant support [5 (1.5%)] for both. The top reported strength points were having an opportunity for professional development [96 (29.2)] and being in an academic institution [97 (29.5)]. Of the total participants, 200 (60.79) of the participants suggested the need for more training on research methodology. Conclusion: This study demonstrated the barriers that face healthcare providers in the MENA region. Because of the inadequate training in clinical research implementation and the lack of designed system operating procedures for the research process, we should address to facilitate clinical research in the region. Keywords: clinical research in Arabic countries, barriers to participating, attitude, conducting research studies

  • Clinical and Medical Case Reports
Location: Webinar
Biography:

Dr. Joxel Garica is the former four-star admiral in the U.S. Public Health Service Commissioned Corps. who served as the fourteenth Assistant Secretary for Health (ASH), U.S. Department of Health and Human Services. He served as the Director of Health in the District of Columbia and was the Commisioner of Health for the State of Connecticut. He served as the Executive Director of the MD Anderson Cancer Control and Prevention Platform and Member of the Leadership Team of the MD Anderson Moon Shots program before joining American Express as Vice President and Chief Medical Officer. He serves on the Board of the Prevent Cancer Foundation. He presently is the Founder and CEO of Ambitna.

 

Abstract:

The 21st Century Cures Act (Cures Act), signed into U.S. law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. Furthermore, the Cures Act facilitates development and approval of genetically targeted and variant protein targeted drugs for treatment of rare diseases. While the Cures Act has the potential for positive transformational delivery of innovative care, it also created uncertainty in the operationalization of the regulations for industry for compliant, sustainable service and payment models. Presently only 4-8% of eligible candidates for clinical trials participate in them. Patients have difficulty understanding or accessing the opportunity for clinical trial therapies. This represents a delay to the approval of new drugs and therapies, understanding of all side effects and true dosing. This also increases the chances that after drug approval, the number of side effects, complications and dosing issues create a major liability burden for the pharmaceutical and the health care system involved. In partnership with Meharry Medical College, the U.S. largest private, independent historically black academic health sciences center, Ambitna designed an automated system to match patients based on diagnosis with eligble clinical trials and connect with CROs. The regional clinical trial matches can increase success of a CRO fulfilling the cohort with more diversity on gender, race, ethnicity and age, thus decreasing liability and increasing ROI on the product.

Biography:

Dr. Abdul Aziz Harith is a medical doctor. Trained in master of public health from National University of Malaysia.Has been well trained as a health implementer as well as initiating policies.Currently, posted in Occupational Health Research Centre, Institute for Public Health Malaysia.

 

 

Abstract:

Objective: This study aimed to determine the current status of IDD among first trimester pregnant women in Sarawak after 3 years of previous IDD survey in 2015

Methods: This is a cross sectional study of IDD conducted between July and September 2018 involving all divisions in Sarawak. A total of 30 Maternal and Child Health Clinics were selected using proportionate to population size (PPS) method and 677 pregnant women in the selected clinics were randomly selected via systematic sampling. Urinary iodine was measured using in-house microplate method. Respondents with urinary iodine concentration (UIC) of<150, 150-249, 250-499, and ≥500 g/L were considered to have insufficient,adequate, more than adequate, or excessive iodine levels, respectively (WHO/UNICEF/ICCIDD, 2007). Chi-squaretest was use to compare the UIC values of respondents from all divisions

Results: The prevalence of goitre rate (TGR) was found to be 1.0% (n=10). The median urinary iodineconcentration (UIC) level for whole Sarawak was 123.9µg/L (IQR 56.5-192.1µg/L) which indicating iodinedeficiency. Median UIC for Sri Aman and Mukah had achieved adequacy of iodine intake which were 150.7 (IQR128.2-235.8) and 170.2 (IQR 119.1-264.7) respectively compare to others were range between 75.4 µg/L to 145.4µg/L

 

Conclusion: Majority of the pregnant women in Sarawak still have insufficient UIC (<150μg/L). However, medianUIC in 2018 (123.9μg/L) improved 12.2% compared with study in 2015 (105.6μg/L). Therefore, this study showsimportant of USI and regular monitoring of the UIC level in the communities to eradicate IDD in the Sarawak

 

  • Risk assessment and management in clinical trials
Location: Webinar
Biography:

Jing Qi was a Associate Researcher · She was also  Clinical Research Associate · Clinical Research Coordinator · Clinical Research Assistant · Clinical Data Coordinator

 

 

Abstract:

BACKGROUND:Motor dysfunction is a primary feature of Parkinson’s disease (PD), with postural instability, one of the key features that lead to an increased likelihood of falls. This study investigated whether Transcranial Direct Current Stimulation tDCS has a beneficial effect on balance control during single task and dual task conditions while standing on stable and unstable surfaces in people with Parkinson’s’ disease.

METHODS:tDCS (1 mA; 20 minutes) was applied with the anode electrode (5x7 cm2) over the Left-DLPFC, and the cathodal electrode (10x10 cm2) over the right supraorbital area. 16participants with early stage PD (65.38 ± 9.722 years) completed four single tDCS sessions in a randomised order: real or sham stimulation, whilst standing on stable or unstable surface. There were four testing blocks (1 pre-stimulation, 2 start of stimulation, 3 middle of stimulation, 4 post-stimulation). In each block there were three single task and three dual-task trials (30 s). Path length (PL)  from force plate centre of pressure (COP) was recorded and analysed; increased PL indicates greater postural instability.

RESULTS:Path length COP was greater during stimulation compared to sham (p<001), on the unstable compared to the stable surface, (p<0.001), and during the dual task compared to the single task,(p<0.001). There was a significant block effect: PL was decreased during the Post-stimulation block relative to the Pre-stimulation block (P=0.042). There was a Surface x Block interaction (p=0.024). On the stable surface PL was decreased on Block 2 relative to Block 1 (p=0.048). On the unstable surface Block 4 (post stimulation) PL was decreased relative to all other blocks.

CONCLUSIONS:

In contrast to expectation, real tDCS increased postural instability. tDCS had no effect relative to the cognitive task (single task vs dual task) or surface (firm vs foam). 

  • Regulatory Affairs
Location: Webinar

Session Introduction

MonishaSundar

CRA School Montreal Torrento, Canada

Title: Transforming Clinical Trials with advanced Data Sciences and Artificial Intelligence
Biography:

MonishaSundar has completed her Master of Human Genomics, Panjab University, India and also pursing “Advanced Post Graduate Diploma in Clinical Research & Medical Writing” from James Lind institute; United States. She had contributed her valuable 8 years in Pharmacovigilance (PV) sector with Parexel International. Later on, she had moved to canada and observed that Canadian skilled new immigrants especially in PV and clinical trial industry are facing many job search related issues. Henceforth, she has involved with CRA School Montreal; Canada as “PV and clinical research consultant”. The purpose is to help many new skilled immigrants to provide the right guidance along with direction related to clinical research and other programs till job placement assistance in entering the field of clinical trial management and administration

Abstract:

Data Sciences is an interdisciplinary approach that helps analyze voluminous data sectors, generated by digital sources, and thereby deriving actionable insights. While Data Science has been successfully deployed across multiple industries, pharma is gradually picking up on its transformative potential. Pharma is undergoing a paradigm shift in the way clinical research is conducted, studies are designed, data are collected, care is provided and outcomes are achieved. With nearly 80% of clinical trials failing to meet enrollment timelines, a better, more efficient approach to trial feasibility is critical. Fortunately, the availability of new analytics tools and an increase in data sources has led many companies to adopt a data-driven approach to decision-making during the feasibility process.

 

  • Adoption of Innovative Clinical Operations Technology
Location: Webinar

Session Introduction

Stephen Hsu

Public university in Montclair, New Jersey

Title: Basic and Translational Research Areas
Biography:

Dr. Stephen Hsu earned a bachelor’s degree from Wuhan University in China, a Master of Arts degree from Montclair State University and Ph.D. degree from the University of Cincinnati. He spent four years at Memorial Sloan-Kettering Cancer Center before joining the Medical College of Georgia (now part of Augusta University). He is well-recognized in translational research and inventions on the benefits of green tea polyphenols, with more than 60 publications. Dr. Hsu’s research is supported by grants from NIH, US Army, and other funding agencies. He is a frequent speaker at various CE courses, and domestic and international conferences

 

Abstract:

1. Mechanisms and signal transduction pathways associated with green tea polyphenol-induced differential intracellular response in normal and malignant epithelial cells, and the application of these phytochemicals as potential chemo preventive measure against oral and skin cancer.

2. Beneficial properties of green tea constituents to prevent and manage skin diseases such as psoriasis, and to improve skin conditions.

3. Potential application of green tea polyphenols in prevention and management of autoimmune disorders associated with Sjogren's syndrome.

4. Potential application of lipophilic EGCG to treat herpes simplex infections.

5. Virucidal disinfectants with long-lasting effect against non-enveloped viruses.

 

Biography:

NigusseZerihunTesfaye has completed Diploma in Chemistry from Kotebe Teaching College in 2006 and Bachelor of Pharmacy degree in 2011 from Addis Ababa University, Ethiopia. He was trained on the area of surveillance of insecticide resistance mosquitoes at KEMRI, Kenya Research Center. He is working as a Senior Clinical Pharmacist at Addis Ababa University, College of Health Science, Black Lion Specialized Teaching Hospital. He also serves as a Drug Supply Management Coordinator, The Head of Special Pharmacy of the hospital, the Secretary of Drug Therapeutic Committee (DTC) and other committee works., College of Health Sciences, Addis Ababa University

 

Abstract:

Objective: To evaluate the antileishmanial activity of methanolic extract of Aloe otallensis (A. otallensis) on the promastigote stage of Leishmaniadonovani (L. donovani) as compared to standard drugs and to screen its phytochemical constituents.

Methods: Phytochemical screening was done by using the method mentioned by Evans and Trease on methanolic extract of the exudates of Aloe otallensis leaves. The extract was also evaluated for in vitro antileishmanial activity against L. donavani which is found from the Parasitology Unit of Black Lion Hospital. The result was compared to standard drugs of sodium stibogluconate, milfostin and paramomycin.

Results: The extract has a good antileishmanial activity with an IC50 of 0.1230 μg/mL on L. donovani (AM 563). The experimental data showed that relatively it had better activity than paramomycin and milfostin but less activity than sodium stibogluconate. The data analyses were done by GraphPad Prism version 5 software after it was read by ELISA reader at the wave length of 650 nm. The phytochemical screening of the exudates of A. otallensis showed the presence of phenol, alkaloid and saponin.

Conclusions: The methanol extract of the exudates of A. otallensis has a good antileishmaniasis activity and this may be attributed to phenol, alkaloid and saponin present in the plant. But it needs further analysis for the conformation of which constituent presents in high concentration to know which one has the strongest effect

  • Clinical & Experimental Dermatology
Location: Webinar

Session Introduction

Nihal El Habachi

AlexandriaUniversitySchoolofMedicine,Alexandria,Egypt.

Title: Clinical trials in Egypt: Opportunities and Challenges
Biography:

A practicing physician in the field of healthcare in the state of Kerala in India for the last 31years and very much interested in basic research. My interest is spread across the fever, inflammation and back pain. I am a writer. I already printed and published nine books on these subjects. I wrote hundreds of articles in various magazines.

After scientific studies, we have developed 8000 affirmative cross checking questions. It  can explain all queries related to fever

 

Abstract:

Egypt's global share from clinical trials is very small in spite of being a strategic country in MENA region with large population.

There are lots of opportunities attracting pharmaceutical companies to invest in the field of clinical trials in Egypt as the low expenses represented in  the Investigator & site fees , cost for trial-related care and  much lower overhead fees, travel costs for monitoring sites and Support services (as printing, translation, and local courier fees).

Also, the high quality investigators and site staff, keen to participate in clinical trials. As well as, Large pool of trial-naive, often treatment-naive patients, High incidence and prevalence of certain diseases and less competition for enrolment of patients.

On the other hand, there are lots of challenges facing people working in clinical trials as unexplained disapproval set by the concerned Authorities on the exportation of the biological samples to central labs, prolonged and undefined/unpredictable study approval/start-up timelines, absence of national clinical research law regulating clinical research and absence of national database registry for clinical trials.

Challenges regarding research subjects, investigators, REC, regulatory authorities, sponsors and local facilities as well as our ways to overcome them will be discussed.

 

  • Clinical Trials Pharmacovigilance
Location: Webinar

Session Introduction

K. M. Yacob K. M. Yacob

Marma Health Centre, Kochi, Kerala, India

Title: Will fever cure if we treat the cause of disease or the cause of fever?
Biography:

A practicing physician in the field of healthcare in the state of Kerala in India for the last 31years and very much interested in basic research. My interest is spread across the fever, inflammation and back pain. I am a writer. I already printed and published nine books on these subjects. I wrote hundreds of articles in various magazines.

After scientific studies, we have developed 8000 affirmative cross checking questions. It  can explain all queries related to fever

 

 

Abstract:

The physicians are talking about the treatment of fever indifferently. They are talking about not to treat fever but for the underlying cause of fever. At the same time when people have a fever, they instruct to reduce fever urgently.

The cause of fever and cause of disease both are different. The physicians misunderstand the cause of disease as cause of fever. If we remove the cause of disease the fever never cures. If we remove the cause of fever, it can be immediately cured. The basic cause of fever is increased severe inflammation and decreased blood circulation. If we remove the cause of disease, the disease will not be cured.

 If a worm eats the stem and leaf of a plant, we can kill the worm with pesticides, then the destroyed part of the plant will not recover completely. Likewise, we can kill some kind of bacteria with antibiotics. But the problems made by bacteria will not be resolved.

The actual treatment to cause of fever.

The actual treatment to fever is to increase blood circulation. Two ways to increase blood circulation. 1. Never allow body temperature to lose 2. Apply heat from outside to the body. When the temperature produced by the body due to fever and heat which we applied on the body combines together, the blood circulation  increases.

Then the body will stop to produce heat to increase blood circulation. And the body will get extra heat from outside without any usage of energy.

 

How can we prove that the cause of fever and cause of disease both are different?

“If we ask any type of question-related to fever by assuming that the cause of fever and cause of disease both are different, we will get a clear answer. If we avoid or evade from this definition, we will never get a proper answer to even a single question

If we do any type of treatment by assuming that the cause of fever and cause of disease both are different, the body will accept the cause of fever, at the same time body will resist whatever treatment to decrease temperature and blood circulation.

 No further evidence is required to prove the cause of fever and cause of disease both are different.

 

Dr.Claudine Kumba

Medical Doctor Paediatric Anaesthesia and Critical Care Necker Enfants-Malades University Hospital France

Title: PerioperativeEchocardiographicHemodynamicParameters and PostoperativeOutcome inPediatricSurgical Patients : Descriptive Observational Pilot Studies
Biography:

Claudine Kumba graduated as a Medical Doctor in 2001 and completed her specialization in Anesthesiology in 2006 at the Free University of Brussels (ULB, Université Libre de Bruxelles), Brussels, Belgium. She has a Pediatric Anesthesia specialization graduation since 2010 from the University of Aix- Marseille, Marseille, France. She has a specialization graduation in Echocardiography applied to Anesthesia and Critical Care from the University of Montpellier 1, 2011-2012, Montpellier, France.
 She has a Critical Care Medicine specialization graduation since 2014 from the University of Montpellier 1, Montpellier, France. She is preparing her PhD Thesis entitled ‘Do goal directed therapies improve postoperative outcome in children ? (Perioperative Goal Directed Fluid and Hemodynamic Therapy ; Transfusion goal directed therapy using viscoelastic methods and enhanced recovery after surgery and Postoperative outcome)’ at Université de Paris, University of Paris, Paris, France.She has research interests in Transfusion; Goal directed Fluid and Hemodynamic Therapy; Enhanced recovery after surgery in Pediatric Anesthesia and Critical Care. She is a Medical Doctor in Pediatric Anesthesia and Critical Care in Necker Enfants-Malades University Hospital, in Paris, France, She is a member of the European Society of Paediatric Anaesthesiology (ESPA), the French Society of Anaesthesia and Critical Care (SFAR, Société Française d’Anesthésie-Réanimation) and the French Association for Pediatric Anesthesiolgists and Intensivists) (ADARPEF, Association d’Anesthésistes et Réanimateurs Pédiatriques d’Expression Française).

Abstract:

Background :Two pilot observational trials wereelaborated,  in pediatric patients scheduled for congenitalheartdiseasesurgicalrepair and in non cardiacpediatric patients  (1,2). Thesestudieswereundertaken to determineperioperativeechocardiographicparameterspredictive of postoperativeoutcomes in terms of morbidity, length of intensive care unit stay (LOSICU), length of mechanical ventilation (LMV), length of hospitalstay (LOS), fluidtherapy and vasopressor-inotropictherapy.

Theseechocardiographichemodynamicparameterswillbeintegrated in tworandomizedcontrolled trials (RCT) inpediatriccardiacsurgery and  in non cardiacpediatricsurgical patients (3,4). These RCT willdetermine the impact of perioperative goal directedfluid and hemodynamictherapy  (PGDFHT) on postoperativeoutcome in children in terms of postoperativemorbidity, LOSICU, LMV, LOS, fluidtherapy and vasopressor-inotropictherapy. All theseclinical trials are part of a Thesisin preparationentitled‘Do  goal directedtherapiesimprovepostoperativeoutcome in children ? (Perioperative  Goal DirectedFluid and HemodynamicTherapy ; Transfusion goal directedtherapyusingviscoelasticmethods and enhancedrecoveryaftersurgery and Postoperativeoutcome)’.This Thesis in preparationcanbevisualizedat http://www.theses.fr/s232762.

 

Objectives : To determineperioperativehemodynamicechocardiographicparameterspredictive of postoperativeoutcome

 

Results : Preliminaryresults are presented

 

Conclusions : Theresults of thesepreliminary trials willbeintegrated in RCT to determine the impact of PGDFHT on postoperativeoutcome in children.

Abdul Aziz Harith

Institute For Public Health Malaysia, Malaysia, 2: Sarawak State Health Department, Malaysia

Title: THE IODINE STATUS OF FIRST TRIMESTER PREGNANT WOMEN AND ITS ASSOCIATION WITH HOUSEHOLD COVERAGE WITH ADEQUATELY IODIZED SALT IN SARAWAK
Biography:

Dr. Abdul Aziz Harith is a medical doctor. Trained in master of public health from National University of Malaysia. Has been well trained as a health implementer as well as initiating policies. Currently, posted in Occupational Health Research Centre, Institute for Public Health Malaysia.

Abstract:

Objective: This study aimed to determine the current status of IDD among first trimester pregnant women in Sarawak after 3 years of previous IDD survey in 2015 Methods: This is a cross sectional study of IDD conducted between July and September 2018 involving all divisions in Sarawak. A total of 30 Maternal and Child Health Clinics were selected using proportionate to population size (PPS) method and 677 pregnant women in the selected clinics were randomly selected via systematic sampling. Urinary iodine was measured using in-house microplate method. Respondents with urinary iodine concentration (UIC) of <150, 150-249, 250-499, and ≥500 g/L were considered to have insufficient, adequate, more than adequate, or excessive iodine levels, respectively (WHO/UNICEF/ICCIDD, 2007). Chi-square test was use to compare the UIC values of respondents from all divisions Results: The prevalence of goitre rate (TGR) was found to be 1.0% (n=10). The median urinary iodine concentration (UIC) level for whole Sarawak was 123.9µg/L (IQR 56.5-192.1µg/L) which indicating iodine deficiency. Median UIC for Sri Aman and Mukah had achieved adequacy of iodine intake which were 150.7 (IQR 128.2-235.8) and 170.2 (IQR 119.1-264.7) respectively compare to others were range between 75.4 µg/L to 145.4 µg/L Conclusion: Majority of the pregnant women in Sarawak still have insufficient UIC (<150μg/L). However, median UIC in 2018 (123.9μg/L) improved 12.2% compared with study in 2015 (105.6μg/L). Therefore, this study shows important of USI and regular monitoring of the UIC level in the communities to eradicate IDD in the Sarawak