Day 2 :
- Workshop
Session Introduction
Lee Truax-Bellows
Founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA)
USA
Title: The future of clinical trial conduct demands a quality system approach: Are you ready?
Biography:
Lee Truax-Bellows is a Founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a full service clinical contract research organization (CRO) based in upstate NY. Lee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, GCP Trainer, and Regulatory and SOP Consultant. She has been involved in regulated research the past 25 years and currently specializes in product development, GCP auditing, and SOP development and training on regulated research and Good Clinical Practice. Lee is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech Association and Society of Quality Assurance (SQA). Lee is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).
Abstract:
The latest emphasis from regulatory authorities within clinical study conduct is to design, develop and execute clinical studies using a Quality System Approach. While both the FDA and EU emphasize this approach, regulatory agencies provide little direction on how this can be achieved. The latest example of such an approach can be found within the FDA’s guidance on conducting a risk-based approach to monitoring. Risk management is an integral component of a quality system approach. As with a Quality System Approach many researchers do not have the knowledge or experience to conduct clinical trial risk management. This workshop will apply practical approaches and demonstrate associated tools and skills, to assist the participant in using a Quality System Approach within the clinical trial arena.
- Track 4: Transforming Trials Methodologies: Clinical Studies
Track 5: Molecularly Targeted Trials: Comparative Approach
Track 6: Challenges and Advancement in Breast Cancer Trials: Case Study
Track 8: Business development in Clinical Trials
Chair
Helen Snooks
Swansea University Medical School, UK.
Session Introduction
Helen Snooks
Swansea University Medical School, UK
Title: Using electronic routine linked health records in HTA of interventions in emergency care
Biography:
Helen Snooks is the Professor of Health Services Research in the Swansea University Medical School, UK. She is the Interim Director of the Swansea Trials Unit (STU) and leads the Patient and Population Health and Informatics (PPHI) research stream at Swansea University. Helen’s main research interests and expertise lie in the fields of Emergency Pre-hospital and Unscheduled Care, Clinical Audit and Effectiveness, and research support. The focus of her work is to plan, design and carry out evaluations of health technologies and new models of service delivery. Helen has a Bsc (Hons) Economics, Sociology, Statistics from University of Surrey with a PhD in Health Services Research ‘Post Traumatic Stress Disorder in seriously injured accident victims’ at the University of Sheffield in 2000.
Abstract:
Background: The SAFER programme conducts research into treating falls in older people; SAFER1 was a pragmatic cluster randomised controlled trial that examined a Computerised Clinical Decision Support system for paramedics, using a hierarchy of outcomes comprising death, unscheduled hospital admission, unscheduled ED attendance, and 999 calls. SAFER2 used a similar study framework to assess new protocols which allow emergency ambulance paramedics to assess and refer patients to appropriate community based care. Objectives: In SAFER2, all participants consent to follow up through routine medical records, and some by postal questionnaire. We consider (a) the characteristics of those providing data through two routes, (b) the consistency between data on hierarchy outcomes available through the two routes, and (c) any resulting effect on reported study outcomes. Methods: Routine medical records are available anonymously through the SAIL Databank in Wales and HSCIC in England; following successful linkage with study participants, data on each component in the hierarchy of outcomes is assessed at one month (for safety)and six months (for effectiveness). Data on QoL is also available at both time points. Results: Data from the two routes are broadly consistent; linkage problems are diminishing as experience develops. Respondents to postal questionnaires comprised approximately one quarter of study participants, and were generally younger & healthier than non-respondents. HTA of the SAFER2 intervention reaches similar conclusions with data from different routes. Conclusions: Routinely recorded data provides accurate information on the full range of study participants over multiple time points in follow-up, are based on increased sample sizes, and are more generalizable.
Biography:
Dr. Rania Abdelmonem Mostafa Khattab has completed her Ph.D in 2012 from Faculty of Pharmacy, Cairo University, Cairo, Egypt, Microbiology and Immunology Department. She is a lecturer at Microbiology and Immunology Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt. She has got Cairo University International Publication Award, Egypt in 2013. She has many teaching experiences for both undergraduate and postgraduate courses e.g. basic microbiology and immunology, pharmaceutical microbiology, quality control of herbal drugs and biotechnology. She has attended many workshops and some conferences with poster presentation in the Global Biotechnology Congress, Boston, MA, USA in June 2014. She published some papers in International Journals.
Abstract:
Purpose: To determine the association between chlamydial conjunctivitis and genital infection by Chlamydia trachomatis, Mycoplasma genitalium and Candida albicans, in addition to the possible relationship between cultured bacterial pathogens and oculogenital chlamydial infection.
Methods: This study was performed on 100 (50 symptomatic and 50 asymptomatic) women attending the Gynecological and Obstetric outpatient clinic of Alzahra hospital. Simultaneously a conjunctival swab was taken from these patients. Polymerase chain reaction (PCR) was done on DNA extracted from both vaginal and conjunctival swab samples. Culture for both vaginal and conjunctival swabs was also done.
Results: Candida albicans was the predominant organism isolated by culture in 20% and 40% of conjunctival and vaginal swabs respectively. By the PCR method, ocular Chlamydia trachomatis was present in 60% of symptomatic women, while genital Chlamydia trachomatis infection was present in 30% of symptomatic women. The results of this method also indicated that 25/50 (50%) vaginal swabs were positive with PCR for Candida albicans versus 15/50 (30%) were PCR positive in conjunctival swab. Mycoplasma genitalium was present in only 10% of vaginal swabs. A percentage of 73.3 of PCR positive ocular Chlamydia trachomatis cases showed no growth of pathogenic organisms in conjunctival swabs, and Staphylococcus aureus and Klebsiella spp. were genitally isolated in 53.4% of PCR positive genital Chlamydia trachomatis (26.7% each). Concomitant oculogenital PCR positive results for Chlamydia trachomatis and Candida albicans were 30% and 28% respectively.
Ocular Chlamydia trachomatis patients by PCR had also genital Chlamydia trachomatis in 50% of women; while genital Mycoplasma genitalium and Candida albicans were also present in 16.67% and 33.3% respectively in those ocular Chlamydia trachomatis PCR positive patients.
Conclusion: We can conclude that ocular Chlamydia trachomatis was associated with genital Chlamydia trachomatis in a high percentage of women followed by Candida albicans. Cultured bacterial organisms do not play a role in enhancement of Chlamydia trachomatis infection.
Key words: Chlamydia trachomatis - Mycoplasma genitalium - Candida albicans - vaginal swabs - polymerase chain reaction - Egypt.
Eliza ML Wong
The Chinese University of Hong Kong, China
Title: The effectiveness of a home-based interactive e-health educational intervention for middle-aged coronary heart disease (CHD) adults in improving total exercise, adherence rate, exercise efficacy and outcomes: A randomized controlled trial
Biography:
Professor Eliza Wong has an extensive clinical experience, an academic and researcher and currently an assistant professor of Nethersole School of Nursing, Faculty of Medicine, the Chinese University of Hong Kong. Professor Wong has a strong research interest in the field of e-health educational intervention in cardiac care and preventive care, cardiac rehabilitation and acute care. Her grants and international publications encompass a number of RCT studies in cardiac care and acute care including e-health educational intervention, pain management and wound care. She has published more than 25 peer reviewed journal articles and over 40 international conference papers.
Abstract:
Introduction:
Coronary heart disease (CHD) is the leading cause of death globally, and e-health educational programs have been proved to be an effective support to patients. Considering the advantages of e-health programs, as well as the growing number of young patients with CHD in Hong Kong, we plan to conduct a randomized controlled trial (RCT) to investigate the effectiveness of a home-based interactive e-health educational intervention for patients with CHD in terms of improvements in total physical exercise, exercise adherence and self-efficacy, risk factor profile, psychological outcomes, and quality of life.
Methods and analysis:
The RCT will be conducted in two government cardiac clinics in Hong Kong. Using a block randomization method, 438 eligible CHD clients will be randomly categorized to either the control group or the intervention group. All participants will receive usual care, but those in the intervention group will additionally receive the e-health educational intervention program. This program will consist of a one-hour educational session, one telephone follow up, and an e-health link on self-monitoring, which includes the recording of health measures and physical exercise across six months. Data will be collected at baseline, three-, and six-month intervals. The primary outcomes will be total physical exercise, which will be measured by the Godin–Shephard Leisure-Time Physical Activity Questionnaire. The secondary outcomes will consist of exercise efficacy and adherence rate, CVD risk profile, physical and psychological health outcomes (as measured by the Chinese version of the Health Survey Questionnaire and Hospital Anxiety and Depression Scale), and biological parameter. The data will be analyzed using mixed effect models and confirmatory factor analysis.
Biography:
Ruqaiya Al Balushi, PhD is an Assistant Professor in Clinical Nutrition at the Nutrition and Health Department, United Arab Emirates University (UAEU). Dr. Ruqaiya received her PhD in Clinical Nutrition from School of Medicine from University of Queensland in 2013. She did her MSc degree in Nutrition and Food Science from Sultan Qaboos University and her BSc degree from the University of Jordan. She worked as a clinical Dietitian from 2003-2005 and the head of the dietetics department at Royal Hospital in Oman from 2005-2014. She was an active member in the Nutrition Support Committee at Royal Hospital and helped in planning the Enteral Nutrition Support protocols at Royal Hospital. Her main research interests include enteral and parenteral nutrition support. She is specifically interested in the field of immunonutrition and pharmaconutrition and the therapeutic effect of glutamine supplementation in critically ill patients and other patient populations. She is also interested in Hospital Malnutrition. She has a number of publications in peer reviewed journals and two book chapters. Her main goal is to increase the awareness about the importance of Nutrition Support in UAE and Oman.
Abstract:
Introduction: Glutamine is the most abundant amino acid in the body acid in the bodyand has been considered non-essential in the past because it can be synthesized de novo. However, during stress and catabolic conditions such as multiple trauma and critical illness, the demand for glutamine increases and its concentration in plasma and muscle fall dramatically. Therefore, glutamine has been re-classified as an essential amino acid under such conditions. Despite the numerous clinical trials that have investigated the beneficial effects of glutamine supplementation in patients receiving enteral nutrition, the results are conflicting and inconclusive. This study aimed to determine the effect of intravenous alanyl-glutamine (Ala-Gln) supplementation on improving organ dysfunction and reducing infectious complications in multiple trauma patients receiving enteral nutrition.
Methods: A triple-blinded, randomized, controlled clinical trial was conducted to investigate the effect of intravenous Ala-Gln supplementation on organ failure, infectious complications and body composition in multiple trauma patients receiving enteral nutrition. Participants were randomly allocated (block-randomization) to receive either intravenous Ala-Gln (0.5 g/kg body weight; n=15) or intravenous placebo (n=15). Both groups received the same standard enteral nutrition protocol and the same standard intensive care unit care.
Outcomes/ Results: The primary outcome, which was the pattern of change in total Sequential Organ Failure Assessment (SOFA) score from day 2 to day 11 (over 10 days), was not significantly different between groups (intention-to-treat: regression coefficient 0.4938, 95% CI=-0.8113-1.7988, p=0.46; per protocol: regression coefficient 0.7220, 95% CI=-0.9758-2.4197, p=0.41). Although there was no significant difference reported in infectious complications with Ala-Gln supplementation, there was a slight reduction in ventilator-associated pneumonia (VAP) cases (2 vs. 6; p=0.21). Similarly, there were no significant differences in other secondary outcome measures (number of days of antibiotic use, number of ventilator-free days, ICU and hospital length of stay, protein levels, albumin levels and lymphocyte count). However, there was a significant increase in urea (p=0.001) and creatinine (p=0.01) levels in the Ala-Gln group. There was no significant difference in fat-free mass percentage (p=0.12) or fat mass percentage (p=0.12) between groups. Although there was a significant overall decrease in fat-free mass percentage over time in both groups (p=0.002), the rate of decline in the Ala-Gln group was slower, suggesting a beneficial effect.
Conclusion: Overall, the beneficial effect of intravenous Ala-Gln was not confirmed in this trial possibly due to a type II error. A rigorous, multicentre trial is needed to confirm the efficacy of intravenous Ala-Gln supplementation in preserving lean body mass, and reducing VAP and infectious complications in multiple trauma patients receiving enteral nutrition. Furthermore, the significant increase in urea and creatinine levels suggests further investigation about the safety of glutamine supplementation on renal function.
Biography:
Dr. Maha Mohssen has completed her M.D from Kasr El Eini Cairo University, she is a lecturer and researcher at the Micro Biology department at the Research Institute of Ophthalmology. Moreover, Dr. Maha also works as the head of the Bacteriology Corneal Unit at the Research Institute of Ophthalmology.
Dr. Maha has published several papers in reputed journals, and is also a member in the Egyptian Microbiology and Immunology Medical Society. In addition to the Egyptian Ophthalmological Society
Abstract:
Aim: To determine the possibility of the development of dry eye disease (DED) as a result of persistent infection with C. trachomatis and U. urealyticum in patients’ conjunctiva.
Methods: This study included 58 patients age range 20-50 years, diagnosed with DED. Control subjects were 27 non-dry eye group (same age range). Conjunctival scrapings were collected for bacterial culture and for detection of C. trachomatis and U.urealyticum by Direct Fluorescent Antibody (DFA) and Polymerase chain reaction (PCR) methods.
Results: C. trachomatis was detected in 65.5% and 76% of DED patients by DFA and PCR methods, respectively. U.urealyticum was found in 44.8% of DED patients by PCR method. Both organisms were identified in 37.9% of DED patients. Control subjects had C. trachomatis (22%) by DFA assay versus 7% by PCR; while U. urealyticum was detected in 3.7% by PCR. Conjunctival culture revealed coagulase negative Staphylococcus (CONS) the most common organism followed by Staphylococcus aureus, whereas gram negative Moraxella spp. was frequently isolated.
Conclusion: Results indicate C.trachomatis and U.urealyticum were detected in DED patients, and implicated in its development. Conjunctival microflora could show some potential value.
Keywords: Dry eye disease - conjunctiva - Chlamydia trachomatis - Ureaplasma urealyticum.
Biography:
Maha Haggag has completed her MD, PhD in 2004 from Cairo University School of Medicine. She is researcher and the head of Allergy Lab in the Microbiology and Immunology Unite, RIO. She has Patency application No.2006040138 at the Academy of Scientific Research and Technology, Egypt in 2006, the subject of Patency is Natural Allergenic Extracts for Specific Immunotherapy as Eye Drops. She published few papers in Egyptian and International Journals with poster presentation in the Unite For Sight Conference at Stanford University USA in April 2007. She worked as Exchange Visitor in the University of Florida, Gainesville, FL, USA for 6 months in 2014.
Abstract:
Infection of the eye results from either the acquisition of a virulent microorganism or uncontrolled growth of an existing organism because of lowered host resistance. In order to detect emergence of antimicrobial resistance it is important to use a practical, consistent, and standardized method that will allow comparison with national or international monitoring data. Results from antimicrobial susceptibility tests should be reported quantitatively rather than qualitatively, providing the minimal concentration of an antimicrobial required to inhibiting the growth of the Microorganism (MIC). This approach would facilitate the detection of small changes in antimicrobial susceptibility over time
Aim: The primary aim of this study is to validate the, performance, accuracy and utility of E test and verify the reproducibility of this convenient predefined gradient methodology for MIC determination in comparison with reference method as broth microdilution.
Evaluation: Evaluation is by testing the sensitivity of selected ocular bacteria; Staphylococcus aureus, coagulase negative Staphylococcus (CNS), Klebsiella and Pseudomonas aeruginosa to three antibiotics; gentamycin, ciprofloxacin and gatifloxacin by three independent assays; disk diffusion, brothmicrodilution and E-test.
Results: The MIC of gentamycin and ciprofloxacin measured by brothmicrodilution & E- test showed significant correlation for all selected bacteria except for CNS. While gatifloxacin showed no significant correlation between the two methods for all staphylococci and Pseudomonas. MIC of the three antibiotics measured by brothmicrodilution & E- test for Klebsiella showed significant correlation.
Conclusion: This study has clearly indicated that each susceptibility test has inherent advantages and limitations. Agar-based methods like E test and the agar disk diffusion represent valid methods compared to the broth microdilution method.
Ting Li
Wenzhou Medical University, China
Title: Study of postoperative delirium in elderly patients undergoing hip fracture surgery
Biography:
Ting completed M.D at The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University. And he is an associate chief physician and Principal Investigator.
Abstract:
Background: Patients with hip fractures have the high incidence of delirium. Postoperative delirium (POD) leads to length of hospital stay, nursing requirements, increases healthcare cost, higher mortality and poor functional recovery. The majority of general anesthetic and sedative agents may favor POD. However, none of studies have investigated the effect of regional anesthesia and general anesthesia on the POD in elderly patients undergoing hip fracture surgery in China. Our research hypotheses are: Regional anesthesia may contribute to decrease the incidence of POD. Regional anesthesia may improve the outcome of elderly patient and reduce healthcare costs associated with POD. POD may result in poor long-term functional outcomes. Methods & Design: This phase 3 study is a multicenter, randomized, open-label and controlled trial. The primary objective of this study is to evaluate the incidence of POD for a period of 7 days after regional/general anesthesia in elderly patients undergoing hip fracture surgery diagnosed with the Confusion Assessment Method (CAM). The secondary objectives of this study are: To evaluate the type, severity and duration of delirium to evaluate the healthcare costs associated with POD; to evaluate the recovery parameters; to evaluate the long-term functional outcomes of elderly patient with POD. The target population are older patient (≥65 years) with hip fracture and planned hip fracture surgery; patient willing to complete this study. A total of 1000 patients will be randomized into 2 study groups (received regional anesthesia or general anesthesia) in the 9 participating centers clinical trial. Conclusion: In conclusion, the results of this comparative anesthesiological trial should allow us to detect whether anesthesia is related to POD rate. This information could ultimately help in selecting the most appropriate anesthesia in patients with high risk for POD. Trial status: Patients are being recruited in three centers currently. The study was initiated in September 2014. To date, 50 patients have been randomized (January 2015) in this study. Recruitment of patients is about 50% slower than expected. So the recruitment period of this trial will be extended from the September of 2015 to the September of 2016. Approximately three out of ten screened patients have been enrolled.
Yifei Jiang
Cincinnati Children’s Hospital Medical Center, USA
Title: Functional near infrared spectroscopy (fNIRS) to identify pain in children
Biography:
Yifei Jiang received her MD and Ph.D. in Anesthesiology from Wenzhou Medical University and postdoctoral training at Cincinnati Children’s Hosptial. Her research focused on anesthetic neurotoxicity and fNIRS to detect and predict pain in children
Abstract:
Pain occurs in children after surgery or with certain diseases and conditions. Many children cannot communicate pain because they are too young or neurologically impaired. Based upon functional magnetic resonance imaging (fMRI), the prefrontal cortex plays an important role in pain perception; the fMRI BOLD signal in this area correlates with painful stimuli in healthy adults. Functional near infrared spectroscopy (fNIRS) is a non-invasive, portable, optical technology that measures changes in oxy-, deoxy- and total hemoglobin (HbO2, Hb, HbT) in the frontal cortex. Our prior study found that fNIRS detected frontal cortex HbO2 and HbT changes analogous to fMRI BOLD changes to painful stimuli in adolescents under anesthesia. In this study, we evaluated fNIRS to detect painful stimuli in young children under anesthesia and in adolescents with chronic pain. Our goal is to develop a non-invasive device to objectively measure pain to improve pediatric pain management.