Day 1 :
Solutions Consultant, Formedix, UK
Time : 10:00-10:30
Ed Chappell has been with Formedix for over 12 years as a Solutions Consultant. He has authored and presented the Formedix training courses for SEND, SDTM, Define-XML, ODM-XML, Define-XML and Dataset-XML. Ed has been heavily involved in the development of the Dataset Mapper ETL language. He has also led the Formedix clinical data programming team which includes Interim Analysis (IA) SDTM and FDA SDTM clinical submissions.
Formedix’ advanced clinical trial automation platform and clinical metadata repository has long been at the forefront of standards-based metadata management for clinical trials. It continues to enhance its scope with some major new functionality. Our new data platform makes it a breeze to pull data directly from an EDC system and convert to SDTM. External systems can use Formedix as a back end for data transformation via APIs, allowing the benefits of our streamlined metadata and data platform to be integrated with your own systems.
- Clinical Trials & Pharmacovigilance
Divyam Institute of Psychiatry, India
Dr. Timirkumar Shah completed MD Psychiatry from Government Medical College Surat, India. He served Chief Psychiatrist at Kasturba Sevashram- renowned inpatient Psychiatry Hospital established by Mahatma Gandhi for 2 decades. He is the founding director at Divyam Institute of Psychiatry- a premier tertiary level centre for comprehensive Psychiatry care. Since 2010, he has been Principal Investigator at Divyam Hospital, a leading clinical research site. He has accomplished more than 35 clinical trials as PI. He also serves as the Chairperson at South Gujarat Independent Ethics Committee since 2013.
On 11 March 2020, WHO declared an outbreak of COVID-19 pandemic followed by lockdowns across the globe. This unprecedented event caused unique challenges: travel restrictions, social distancing, infection risk to trial participants and staff, self isolation if infected, stricter sanitisation , restricted resources, etc. In spite of help available in the form of guidelines from regulatory authority, amendments from Sponsor, virtual training and monitoring from CRO - innovative solutions and mitigating strategies were needed at local level.
Challenges were multifaceted. Sponsors amended documents and procedures, which has to be implemented after approval from Ethics Committee . CRO started remote monitoring and auditing. Simultaneous Communication with sponsor and CRO at one end , and with trial participants at other end was need of time . IMP shipment was disrupted. Samples had to be retained at site for longer time. Data collection to the possible accuracy was required. Due to minimal face to face interaction and need to reduce footfalls at hospital, ICF process became challenging. Assessment schedules were revised . Enrolment had to be paused, and retaining participation faced toughest trial. On site activity were replaced by home visits. Protocol deviation has to be documented briefing extent of affect and rational for deviation. Most critical was to ensure participant’s safety and keeping track of adverse events.
Lessons learned will be helpful in designing and managing trials in the future.
Universitas Islam Bandung, Indonesia
Hendro Sudjono Yuwono belongs to Medical Faculty of Universitas Islam Bandung, Bandung, Indonesia. Teaching of surgery (mostly vascular surgery) to medical students, residents of surgery. Guiding and promoting the students of Master degree and PhD degree; do the research by myself or together with other researcher; presenting the research by oral presentation in national/international symposia/ Congresses/ journal publication.
The coffee powder has inherent capabilities as an antioxidant, anti-inflammatory, and antimicrobial. It is a topical wound dressing for acute and chronic wounds, encouraging results different from the wound dressing known today. It is named the new paradigm of wound management.
The study of coffee powder since 2003 as a topical wound dressing has created an understanding condemn to disturb the cells in the wound bed. During dressing change, a thin layer of coffee powder should stay in place to ensure safety, covering of superficial wound cells’ growth.
The remained thin layer of coffee powder has created minimum detached wound cells compared to other dressing. Wound healing provides effectiveness for acute and chronic wounds resulted in low cost, easy to get, acceptable scar, non-traumatic, pleasant scent, and not scary to patients. since 2003 was more than 300 wound-cases using coffee to treat acute and chronic wounds have shown its sophistication. It is very good support for the economy and the public health concerning wounds’ management.
The utilization of antioxidant, anti-inflammatory, and antibacterial capacities of coffee powder anticipates the injury of the new growth of epithelial cells at the wound bed. It makes better cell proliferation, proper scar formation, easy to get, lovely scent, cost-effectiveness, not scary to the patients. Its simplicity in wound management procedures helps improve public health efforts. Hence, the coffee powder has the capabilities of the best topical wound dressing
Dishant Sanghavi completed his Master degree in Organic Chemistry and subsequently and MBA in Operations Management. ASQ Certified Global auditor, performed 400+ audit worldwide with 16+ years of experinece in QA, CQA and pahramceutical new facility project. Expertise includes Audits and compliance as per various regulatory guidelines i.e. USFDA, MHRA, TGA, EMEA etc. Adept at establishing Quality Management System at internal and CMO sites. Excellant analytical and trouble shooting skill will proven ability in driving nemerous process improvement, quality enhancement and Lean initiatives during the career span.
- Introduction to Data Reliability and Integrity
- ALCOA+ Overview and Expectation
- Group Discussion and Examples
- Repercussions of Data integrity Breaches
- Industry Leader’s prospective to Prevent DIO/DIB
- Individual’s prospective to Prevent DIO/DIB
- Individual Undertaking
Divyam Institute of Psychiatry, India
Dr. Timirkumar Shah has completed his MD in Psychiatry from Government Medical College Surat, India. He served for 2 decades as Chief Psychiatrist at Kasturba Sevashram- renowned inpatient Psychiatry Hospital established by Mahatma Gandhi. He is the founding director at Divyam Institute of Psychiatry- a premier tertiary level center for comprehensive Psychiatry care. Since 2010, he is Principal Investigator at Divyam Hospital, a leading clinical research site. He has accomplished more than 30 clinical trials as PI. He also serves as the Chairperson at South Gujarat Independent Ethics Committee since 2013.
Bipolar I Disorder is a chronic, disabling, and serious mental illness characterized by extreme mood cycles. Protein kinase C (PKC) intracellular signaling is involved in the pathophysiology of Bipolar disorder. PKC plays a crucial role in the regulation of neuronal excitability, neurotransmitter release, regulation of synaptic plasticity and various forms of learning and memory.
Tamoxifen is a Protein Kinase C (PKC) inhibitor and it has shown some benefit in Bipolar Disorder with milder adverse events. Endoxifen (4-hydroxy-N-desmethyl Tamoxifen) is a secondary metabolite of Tamoxifen. Compared to Tamoxifen, It has four-fold PKC inhibitory activity and is also independent of CYP2D6 genetic polymorphism.
I participated in a Phase II study demonstrating efficacy and safety of Endoxifen in BPD I patients. In this 3-arm study, Endoxifen 8 mg dose showed improvement in total YMRS score compared to baseline and were similar to Divalproex. Endoxifen arm had lower incidence of adverse events versus Divalproex.
Here I am presenting a Phase III RCT in a larger patient population evaluating efficacy and safety of 8 mg Endoxifen against active comparator Divalproex Sodium. The primary endpoint of our study was the mean change in total YMRS score at day 21. Results showed Endoxifen (n=116) significantly (p < 0.0001) reduced total YMRS score. Early remission of the disease was observed. None of the patients required rescue medication. There was no drug associated withdrawals. Changes in Clinical Global Impressions-Bipolar Disorder and Clinical Global Impression-Severity of Illness scores showed that treatment with Endoxifen were well-tolerated.
Batra Hospital & Medical Research Centre, India
Priyadarshini Arambam a PhD scholar in Public Health from Amity University. She is the General Manager Academics & Clinical Research at Batra Hospital & Medical Research Centre, a multi speciality hospital. She has published more than 15 papers in reputed journals and has been invited in national and international conferences.
The Corona virus disease 2019 (covid-19) outbreak caused by severe acute respiratory syndrome corona virus-2 (SARS-CoV-2) was sudden and unexpected. Its emergence created significant disruption in various healthcare systems that cut across disciplines including clinical research. Various challenges emanated from multiple stakeholders at research centers due to fear of getting COVID-19, travel limitations, quarantine, isolation, site closures, and interruption of supply chain for the investigational products have impacted both new and ongoing clinical trials for both covid-19 and non-covid-19 studies.
The data is collected from the academics and clinical research department of Batra Hospital and medical research center which is a covid centre. The department employed numerous strategies including home delivery of investigational product by study staff to the participants, modifying the doses of drugs if necessary in the interim to prevent cessation of the study agents, provided alternative means of medical care by investigators and adoption of e-portal for ethics committee functioning to manage and support individual stakeholders.
All the ongoing studies (33) continued to run well with feedback to the individual sponsors. The new recruitment was however a challenge. The strategies applied minimized the risks of protocol deviations without compromising the safety of trial participants, good clinical practice (GCP) and trial integrity.
Challenges emanated from multiple stakeholders during pandemic can be overcome by modifying strategies in compliance with the applicable regulatory requirements that can significantly prevent disrupting the functions of stakeholders at the trial site.
BC Children’s Hospital, Canada
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.
French Association of Pharmaceutical Medicine, France
Francois Xavier Frapaise, MD, has over 30 years of international drug development, strategic planning and marketing experience at major pharmaceutical companies including Sanoﬁ , Bayer and Abbott, has hold multiple C-level positions (CSO, CMO, CEO) in different Pharmacos in the US and Europe. He is currently heading a Biosimilars Development Consulting Company; has extensive experience of biosimilars development (Merck KGaA, Boehringer-Ingelheim, Pfenex). He held an academic position at the Thrombosis Research Center at the Loyola Medical Center in Maywood (IL). He holds an MD degree from Faculté de Médecine René Descartes, Paris France, and is an INSEAD alumni.
By design or by necessity, clinical trials protocol tend to evolve during the course of the investigation and patients must be kept abreast of any significant change to the protocol and consent in writing to the most recent versions of the protocol. Experience shows that the vast majority of patient adequately consent in writing to participate in a given trial, but that many investigators fail to ask patient to “re-consent” to the amended version of the trial.
This can have dramatic consequences, with all the data coming from a clinical center being discarded by the regulators in the analysis
To address this risk, Pharmacos and CROs deploy field monitoring resources and auditors to support investigators and detect this type of compliance issues as early as possible. Unfortunately the currently implemented risk-mitigation solutions by CROs only represent a wide-mesh net.
Blockchain technology, widely used and validated in the bank and insurance industries does provide an opportunity to address most of these consent management risks, as it provides a mechanism for immutable time-stamping of consent forms, storing and tracking of the forms in a secure and verifiable way. Blockchain technology provides a “single point of truth” for all partners involved in clinical research process, enables real-time synchronization of information between partners, while guaranteeing confidentiality and privacy as shared data can be encrypted.
In a time when many stakeholders tend to distrust data and information coming from the Pharmaceutical industry, Blockchain represent an opportunity to provide immutable and unfalsifiable data, hence increased shared trust between pharmaceutical industry and all stakeholders: patients/prescribers/ regulators.
Last, it should be mentioned that Blockchain benefits can also be leveraged in pharma supply chain management, contract management, prevention of counterfeiting.
Bahir Dar university , Ethiopia
Asteray is Midwifery professional currently working as midwifery directorate, lecturer, researcher and community service provider in a teaching university hospital for 5 years. She is a person who believes leadership is an elevator to bring a change. She aspires to work through governmental institution, go up the ladder to go forward. She has a long term plan to be a great African leader who can unify the continent as never before on sexual and reproductive health
Asteray has completed her MSC at the age of 25 years from Bahir Dar university in Midwifery and working as lecturer, researcher and community service provider for 5 years. She is the midwifery director of Tibebe Ghion specialized hospital , a teaching hospital of Bahir Dar university
Background: competency in Clinical practice is a platform for health science students, which has a direct relationship with improving the quality of care provision. Graduates have problems in doing tasks in clinical practice after receiving necessary and adequate theoretical and practical sessions in school life, which compromise the goals of the health care system. Thus the aim of this study was to assess clinical practice competency and associated factors for Undergraduate health science student in Bahir Dar University.
Methods: Institutional based Cross-sectional study was conducted in Bahir Dar University College of medicine and health science students from April 20-May 20/ 2019, by pre tested structured questioner. Simple random sampling was used to select the study participants. Data were entered using Epi Info-7 was exported and analyzed by SPSS-23. Descriptive analysis was done and association of variables were declared at p-value of <0.05.
RESULT: clinical practice competency was 65%. Students with clinical instructor feedback (AOR=1.840, 95%CI:1.021-3.314), sufficient cases in practice area (AOR=1.817, 95% CI :1.014-3.254), clinical instructor spent enough time at clinical site (AOR=3.627,95% CI :1.242, 12.694), integrations of learning domain (AOR=2.199,95% CI :1.152-4.196) and Staff encourage students while practicing (AOR=1.91395%CI: 1.067, 3.432) were the determinant factors for clinical practice competency.
Conclusion: the competency of Clinical practice was low. Clinical instructor feedback, sufficient cases at clinical practice area, integrations of learning domain, Staff encourage students while practicing and instructor spent enough time for mentoring were found to be predictor of Clinical practice competency. So placing students at clinical site having sufficient cases, instructors to be found in practice area and giving constructive feedback, mentoring and coaching students at practice site might have crucial role to enhance clinical practice competency. Additionally, developing a system to control instructor’s who miss practice schedule and integrating the clinical staff to academic staff and giving credit for clinical staff is very is important to improve students competency.
United Arab Emirates University, UAE
Dr. Al-Azayzih is currently an Assistant Professor in the Department of Pharmacology and Therapeutics at United Arab Emirates University, Al Ainm UAE. His current Research projects focuses on Pharmacovigilance, Medication Errors, and Adverse Drug Events Evaluation . He earned his Doctor of Pharmacy (PharmD) Degree from Jordan University of Science and Technology in 2007. He then earned a Ph.D. in Clinical and Experimental Therapeutics from the University of Georgia- College of Pharmacy in 2014.Dr. Al-Azayzih is a Board Certified in Oncology Pharmacy since May, 2014.
Dr. Al-Azayzih has authored has authored 20 original research publications in various Journals including, International Journal of Clinical and Experimental Pharmacology, biochemical biophysical acta, Nanomedicine, Journal of Biological Chemistry, Journal of Clinical and Experimental Therapeutics, Saudi Pharmaceutical Journal, Pharmacy Practice, and others.
He has authored more than 30 abstracts and Papers, presented in local, national and international conferences and received several awards for research and academic excellence.
Due to aging, along with its associated physiological changes, older adults are extremely vulnerable to be afflicted with multiple chronic conditions (Multimorbidity). Accordingly, prescribing a large number of drugs to older adults would be inevitable. Resulted complex drug regimens can lead to prescribing of Potentially Inappropriate Medications (PIMs) with subsequent negative health and economic outcomes.
Aims: The main aim of this study is to measure the prevalence and predictors of PIMs prescribing among Jordanian elderly outpatients, using the last updated version of the American Geriatrics Society (AGS) Beers Criteria (2015 version).
Method: A Unicenter, retrospective cross-sectional study conducted over three months period. Our study included patients aged 65 years or above who visited the outpatient clinics at King Abdullah University hospital (KAUH) and were prescribed at least one oral medication during the study period. PIMs were identified for these patients and further classified according to the 2015 AGS Beers Criteria.
Results: A total of 4622 eligible elderly adults were evaluated in this study, of whom 62.5% (n=2891) were found to have at least one PIM prescribed during the three months study period. 69% of identified PIMs were medications to be used with caution in elderly, 22% were medications to avoid in many or most older adults, 6.3% were medications to be avoided or have their dosage adjusted based on kidney function in older adults, 2.04% medications were to avoid in elderly patients with specific diseases/syndromes, and 1.6% were potentially clinically important non-anti-infective drug-drug interactions to be avoided in older adults. Female gender and polypharmacy were found to be significant predictors of PIMs use among elderly.
Conclusion: Potentially Inappropriate Medication prescribing is common among Jordanian elderly outpatients. Female gender and polypharmacy are associated with more PIMs prescribing and so need further attention.