Day 3 :
- Sessions / Tracks:
Drug Discovery and Development | Clinical Research & Clinical Trials | Conducts of Clinical Trials | Clinical Trials on different Diseases | Clinical Data Management and Statistics | Globalization of Clinical Trials | Future of Clinical Trials | CRO/ Sponsorship Clinical Trials | Outsourcing in Clinical Trials | Clinical Trials Site and Supply Management | Pharmacovigilance and Drug Safety | Post-marketing Surveillance
Federal University of Ceara, Brazil
Luciana Ximenes has completed her PhD at the age of 31 years from Federal University of Ceara. She is a Professor of General Pathology at the Unichristus University Center in Fortaleza, Ceara, Brazil. He has published more than 10 papers in reputed journals and has been serving as an editorial board member of repute. Her research on depression with citronellyl acetate received an honorable mention at the Symposium on Medicinal Plants in 2012.
The citronellyl acetate is a monoterpene present in the essential oil of various plants with citronella. Studies have shown its activity as anti-inflammatory, antimicrobial substance analgesic, antioxidant, and being their biggest use in veterinary as insect repellent.The present study investigated the antidepressant activity in mice in the experimental tests the forced swimming and tail suspension test as well as the involvement of the monoaminergic system in these effects. Citronellyl acetate reduced the immobility time in the forced swimming test and tail suspension test, at doses of 50 and 100 mg/kg, p.o. The anti-immobility effect of citronellyl acetate (50 and 100 mg / kg) was reversed by pretreatment with PCPA 100 mg/kg i.p. (inhibitor of serotonin synthesis), Prazosin 1 mg / kg, i.p. (α-1 adrenoceptor antagonist), Yohimbine 1 mg / kg, i.p. (α-2 adrenergic receptor antagonist), SCH233390, 15 mg / kg, s.c. (D1 dopamine antagonist) sulpiride 50 mg / kg, i.p. (dopamine D2 antagonist). The analysis of the levels of monoamines showed an increase in the levels of monoamines (NA, DA and 5-HT) at a dose of 100 mg/kg of citronellyl acetate and the dose of 50 mg/kg increased levels of NA in striatum of mice. Thus, the study suggests that the anti-immobility effect of citronelila acetate in the forced swim test is related to its action on adrenergic, dopaminergic and serotonergic receptors, which was evidenced by an increase in the levels of monoamines in the brain, suggesting a possible antidepressant effect of this substance.
The University of Hong Kong, China
Ming Hong is a year four PhD student at the University of Hong Kong. His researches are mainly focus on Chinese medicines and liver diseases.
Liver injury caused by hepatotoxic agents is a major health problem that challenges not only health care professionals but also the drug regulatory agencies and the pharmaceutical industry in recent years. Traditional Chinese herbal medicines such as Xiao chai hu tang (XCHT) and Heshouwu are widely used for chronic liver diseases and generally regarded as safe due to their extensive clinical use. However, in recent years, there have been increased clinical case reports regarding the long-term hepatotoxicity risks of these two hepatoprotective Chinese herbal medicines in patients with liver dysfunctions. Herein, based on the network pharmacology framework, we analyzed the potential hepatotoxicity of XCHT and Heshouwu by predicting the hepatotoxic ingredients and identify the molecular targets of hepatotoxicity in XCHT and Heshouwu. As a result, two drug-target networks of hepatotoxicity of XCHT and Heshouwu were constructed and analyzed through network pharmacology assays. This network pharmacology research on herbal hepatotoxicity may provide a forceful tool for exploring the potential toxic ingredients and related intracellular mechanisms of Chinese herbal medicines. However, further experimental verification of the potential hepatotoxicity compounds is needed to validate the accurate interactions between these herbal ingredients and protein targets predicted by the in-silico method.
Glasgow University of Health and Wellbeing, UK
Efe Egharevba is a final year part-time PhD student at Glasgow University’s Institute of Health and Wellbeing. He completed a Master’s degree in Clinical Research at Cardiff University’s Welsh School of Pharmacy in 2008 and obtained a Bachelor degree in Biology from the University of North Texas. He has spent 13 years working for various pharmaceutical companies in clinical operations, overseeing the conduct of clinical trials around the world.
Clinical trials still represent the gold standard in testing the safety and efficacy of new and existing treatments. However, developing regions including sub-Saharan Africa remain underrepresented in pharmaceutical industry sponsored trials for a number of reasons including fear of corruption and unethical behaviour. This fear exists both on the part of pharmaceutical companies, and investigators carrying out research in the region. The objective of this research was to understand the ethical considerations associated with the conduct of pharmaceutical industry sponsored clinical trials in sub-Saharan Africa. Corruption was identified as a significant issue by a number of stakeholders who participated in semi-structured interviews and completed questionnaires. Additionally, fear of being perceived as corrupt or unethical even when conducting ethically sound research was raised as a concern. Thus corruption, whether actual or perceived, is one of a number of issues which have precluded the placement of a greater number of pharmaceutical sponsored clinical trials in this region. More discussion around corruption with all relevant stakeholders is required in order for progress to be made and to enable greater involvement of sub-Saharan African countries in the conduct of industry sponsored clinical trials.
Omrix a J&J company, Israel
Liora Bosch, has been working at Omrix as a biostatistician for the past 4 years and has broad-based experience in study design and data analysis. In her former role, Liora filled the position of a clinical data manager, overseeing multisite clinical trials across the US and EU. In that capacity, Liora worked with leading and cutting edge EDC systems and conducted training for system users. In parallel to her work, Liora is pursuing a master's in biostatistics. As part of her thesis, Liora provides statistical support and analysis for an upcoming clinical trial. Her thesis work is mentored by a fellowship of Tel-Aviv University and Harvard University.
Worldwide, in the past few decades the emerging incorporation of electronic systems has accelerated rapidly. We witness many official services; like banking or government services, and others like shopping or even gambling that have moved on-line, yielding huge efficiency gains for suppliers along with improved customer experience. The question that we should ask is "Where does the clinical trials industry incorporate in that sense?" or, being more specific, "How does the implementation of an EDC system affect the clinical trial working procedures?"
We will start by reviewing the FDA prospective on eSource as a means of clinical data collection followed by examples of electronic data originators. Then continue by giving an overview of the modified data collection and handling procedures and presenting the existence of data element identifiers driven by EDC deployment. When considering EDC implementation there are still barriers to be overcome, all of which can be categorized into the following: high upfront cost, lack of technical knowledge and resistance to change.
On a personal note, in my lecture I will try to address these issues by presenting the available types of EDC systems in the market today. Trying to address the economic considerations via a case study describing a full EDC implementation. In addition, the two last sections will be dedicated to the importance of statistical knowledge when designing an eCRF. Finally, I will conclude by intriguing future availabilities in terms of statistical process control. Incorporating such controls into the EDC system could detect real time unusual data variations and deprive the loss of statistical power.
Background: Effects of combined kinetic-chain exercises on physical performance and quality of life in knee osteoarthritis (OA) has not been reported. This study was designed to investigate and compare the effects open, closed and combined kinetic-chain exercises (OKCE, CKCE and CCE) on performance-based physical function and health-related quality of life (HRQoL) of patients with knee OA.
Method: The randomized clinical trial involved ninety-six consecutive patients with knee OA who were randomly assigned to one of OKCE, CKCE or
Results: The groups were comparable regarding their demographic and dependent variables at baseline; there were no significant intergroup differences in CPWT, FPWT and HRQoL at the end of weeks 4, 8 and 12. CCE group (-2.38±2.52 s) however demonstrated significantly higher mean change in CPWT than either OKCE (-1.31±1.03 s) or CKCE group (-1.44±1.19 s) between baseline and week12. Walking times and HRQoL scores significantly reduced across all-time points of the study indicating improvement for all measures.
Conclusion: Combined kinetic-chain exercises are more effective than either OKCE or CKCE alone for improvement of physical performance in knee OA.
St. Paul’s Hospital Millennium Medical College, Ethiopia
Etsubdink Abera Aboye earned his Medical Doctorate Degree from St. Paul’s Hospital Millennium Medical College in Ethiopia, in November 12, 2013. He graduated with distinction and retained in the Medical College with academic rank of Lecturer and Early Career Researcher. He has participated in various researches that brought positive change to the community, and he is currently participating on ‘the evaluation of a Standardized Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB,’ multicenter trial involving five Hospitals in the City. He worked as President of the Medical Students’ Association, Assistant Student Dean, Modular Coordinator, and Undergraduate Students’ Coordinator. He is currently a fellow at Harvard Medical School-Global Clinical Scholars Research Training Program with Clinical Trial Concentration, and member of Research Ethical Review Committee of his academic Institution since 2016.
Clinical trials in Ethiopia and other developing nations can generally be considered to be in its embryonic stages. The share of studies registered from Africa (in Clinicaltrials.gov) updated as of June 2017 is only 0.025%, although the region represents about 15% of the population of the world; and Ethiopia represents only 1.5% of all the studies from Africa.
Though clinical trials provide the highest degree of evidence to support new interventions and decisions about disease management, the challenges of conducting clinical trials in Ethiopia are enormous. The basic problem arises from the country’s poor economy that resulted in underdeveloped research infrastructure such as space, supplies and maintenance affecting clinical work, communication, access, availability of basic needed inputs, and lack of trained workforce in clinical research.
Besides, there is lower prioritization of research in academic institutions considering research as a luxury; time and money consuming; and this has resulted in the establishment of very few clinical trials units nationwide. There is lack of equitable incentives for researchers due to limited sources of funding and very minimal budget allocation to clinical research activities by the government. The regulatory frameworks are also bureaucratic; and this has been discouraging to the few clinical researchers resulting in brain drain; that is a challenge in health facilities in resource-limited settings as it is associated with increasing workloads, lowering the quality of services, reducing team efficiency and causing a loss of institutional knowledge.
Moreover, poor and/or illiterate study participants and differing cultural values and beliefs may lead to recruitment, consent and follow up difficulties, which slow down trial progress from my experience in Ethiopia.
Management sciences for Health, Rwanda
Dr. Julius Kamwesiga completed his degree in Human medicine and masters of Epidemiology from University of Rwanda. He is the senior health advisor in Health system strengthening project administered by management sciences for Health under USAID funding.He has published more than 6 papers in reputed journals and has been serving as an editorial board member of Joirnal of AIDS.He has been a principal investigator of 2 research projects namely:Rwanda selenium supplementation clinical trial and utilizing HIV/AIDS infrastructure as a gateway to chronic care of hypertension in Africa.
There is a growing interest in the measuring the predictors of quality of life across a wide spectrum of diseases. Patients suffering from HIV are concerned about their survival and their quality of life as well. we assessed quality of life bio-demographic predictors among ART(antiretroviral therapy) naive adult patients in Rwanda. A multi centre study involving 300 pre-Antiretroviral therapy (ART) patients was carried out at two standard care sites in Rwanda. Patients were >=21 years of age with documented HIV(human immunodeficiency virus) infection,CD4 cell count of 400-650 cells/mm3,and not yet on ART were asked about their demographic and quality of life information using MOS-HIV(medical outcome survey of Human immunodeficiency virus) quality of life scale. Blood samples taken for testing CD4 cell count and viral load. Eleven quality of life items were standardized to assess the biodemographic factors that predict the poor quality of life of people living with HIV. logistic regression model , odds ratio with 95% confidence interval and corresponding P values were used to test the association between predicting factors and quality of life(poor or good).
It was observed that Not working for cash 95%CI 0.22(0.19– 0.70) low education 95%CI 0.46(0.22– 0.70), and underweight 95%CI 4.09(1.1– 15) of patients were statistically associated with poor quality of life. This study provide evidence that decreasing values of working for cash correspond with 78% decreasing odds of having poor quality of life. Increasing values of school attendance correspond with 54% decreasing odds of having poor quality of life. Increasing values of underweight correspond with four times increase in odds of having poor quality of life.
Conclusion: The results of this study show that working for cash, school attendance and body mass index in individuals infected with HIV, strongly predicted the quality of life. Thus efforts to expand the income generating activities, adult vocational training , together with improved body mass index can all be potential interventions to address the health related quality of life in adult HIV infected patients in Rwanda.
Harvard Business School, USA
Born in Mexico City, Moses Zonana moved to the U.S. to obtain his B.A. in Mathematics from Rutgers University. He earned his MBA in 2005 from Harvard Business School with academic honors. Zonana has more than 15 years of executive-level experience, where he used his diverse expertise in healthcare, telecommunications and technology to develop the health technology solutions provider, Compliance Meds Technologies (CMT). During his tenure as CEO of a regional mail-order pharmacy, Zonana recognized that the industry was simply supplying and refilling medications without knowing patients’ adherence to dosing regimens. He envisioned CMT as a solution to improve patient outcomes
Pharmaceutical manufacturers have long struggled to create an efficient clinical trial process for faster next phase approval. The root cause of most failures is a lack of necessary efficacy data to support clinical trial claims. Subpar data can be directly tied back to an inability to track and report on patient adherence to drug protocol. Patient adherence is critical to the outcome of clinical trials in determining the drug’s efficacy, establishing dosing guidelines, and receiving market approval. Compliance Meds Technologies (CMT) offers a novel approach to medication tracking during clinical trials with its patented CleverCap devices that track and record real-time dispensation of oral solid medications in the outpatient setting. CMT’s robust cloud-based platform captures detailed dosing logs, enables timely screening and empowers enrichment interventions. CMT’s platform presents data in ways that allow sponsors and CROs to benchmark sites and shed light to investigators regarding correlations between dispensation dosing patterns and efficacy. CMT’s technology is applicable across different phases in research and development: Phase II-IIIb studies, where the participant is not taking the medicine in someone’s presence; PK sampling studies not dosing in clinic, where the exact time that a subject took a dose prior to PK sampling is critical; Protocols that call for complex dosing schedules; Studies that require titration or adaptive studies; Studies in high toxicity therapy classes and narrow PK profiles (e.g. Cancer, Hepatitis C, CNS – MS, ALS, Parkinson’s); Therapy classes with concerns of overdosing or when the study medicine is prone to diversion (e.g. Opioids).