Day 1 :
Research Director, Canada
Time : 10:00-10:40
Vesna Popovska has graduated from medical school in 1988, and completed her residency in Ob/Gyn in 1998 in Skopje, Macedonia. She moved to Canada in 1999 and joined the Division of Maternal Fetal Medicine at BC Women’s Hospital, where she established and lead the MFM Research Program. In 2005, she was recruited by the Neurosciences Program at BC Children’s Hospital, as a senior research manager. She developed and led the program, becoming its director in 2016. She is involved in the strategic planning, and develops collaborative relationship among universities, industry partners and CROs to support and advance patient-oriented research.
During the last decade, number of clinical trials have been offered to pediatric patients with neurological disorders.
Dravet syndrome (DS) or severe myoclonic epilepsy in infancy is one of the most well-known disorders of the epileptic encephalopathies. DS is a highly treatment-resistant and refractory epilepsy syndrome. Establishment of a seizure free condition in affected children, even with anticonvulsant drug polypharmacy, is extremely rare.
Duchenne muscular dystrophy (DMD) is a disabling and life-threatening X-linked genetic disorder affecting males. Boys with DMD develop progressive proximal muscle weakness that leads to deterioration of ambulation, wheelchair dependency, and eventual respiratory and cardiac failure.
Spinal Muscular Atrophy (SMA) is an autosomal recessive neuromuscular disease resulting in atrophy of the voluntary muscles of the limbs and trunk. It is the most common genetic cause of infant mortality, and a major cause of childhood morbidity in the U.S.
Clinical trials in pediatric neurology rare diseases are testing new investigational drugs (IDs). There is still an ethical dilemma if the new treatment will be better than the standard of care. There are number of unknown risks. Patient’s enrollment can be very challenging. The commitment from the families is huge. Most of the clinical trials start with the double-blind, placebo controlled design. Families have to agree on the possibility for their child to be randomized in the placebo arm. Those clinical trials might have very frequent study visits which might cause financial burden. Lot of work needs to be done to address the ethical challenges.
Cambridge Scholars Publishing and Cardiff University, UK
Time : 10:40-11:20
Prof. Ioannis Makedos has completed his PhD at University of Thessaloniki. He is in Advisory Board of Camridge Scholars Publishing and Head of Researche Department in Cardiff University. Apart his academic career, he is working into real business field, as Senior Clinical Data Manager in a CRO. Additionally, has published more than 15 papers in high reputed journals and has been serving as an editorial board member and editor in high ranking scientific journals. Recently, he was awarded for his contribution in the field of the research methodology and on August 2018 his research awarded as the best one during an international conference.
A realistic and innovative solution for having high quality data management which certainly increase the reliability of the clinical research and therefore the fame of the companies (CRO). Our findings indicate that the appropriate research methodology for every clinical study in combination with innovative scientific clinical data management can create absolutely reliable data, zero errors, zero biased data, and high quality conclusions. Specifically, our research was based on 78 different clinical studies’ data, we realized specific research methodology for every study, according to the scientific criteria and to research ethics. We used an innovative statistical method for data analysis combining ANOVA, Chi-Square Test and Econometric Analysis (binary regression analysis model), in order to obtain high quality results, according to the validity and reliability criteria. Our groundbreaking research offers high quality and innovative clinical data management in scientific level, eliminating the biggest obstacle which is the biased results and the errors.