CONFERENCE PRESENTATION · SCDM 2021 Global Conference
Once upon a time in 2019 (BC - Before Covid) and happily ever after 2021 (AC - After Covid): A saga of realizing the benefits of real world data (RWD)
- Session Type: Panel Discussion
- Session Level: Advanced
Overview
To improve outcomes during the COVID-19 pandemic and beyond, organizations have been using real-world data for efficient and effective decision-making.
While randomized controlled trials (RCTs) are pragmatic, these have stringent eligibility criteria and may not fully represent patients seen in everyday clinical practice. As such, results from RCTs are not always generalizable to less idealized settings and more diverse patients. Real-World Data (RWD) can provide supportive evidence for the effectiveness of medical interventions in more heterogeneous populations than RCTs.
The diversity in RWD sources provides researchers with the ability to conduct a variety of RWD evaluations on a range of topics. Different sources allow different questions to be asked, not only offering diverse real-world data (RWD) findings, but also adding to the knowledge gained from traditional RCTs.
- Electronic health records (EHR)
- Wearables, health-related apps and mobile devices
- Claims databases
- Product and disease registries
- Health surveys
- Social media
Real-world evidence (RWE) can be generated by different study designs or analyses that not only need reliable data of good quality, but also need to be approached with strong methodological considerations. The FDA is also due to release new guidance on the use of RWE by the end of 2021, and it’s likely that the guidance will be influenced by the agency’s most recent experiences with RWE and COVID-19.
Please join our session wherein our eminent panelists will share their experiences and use cases of RWD during pandemic and will guide us to develop RWD strategy in the new normal.
What You'll Learn
- What is RWD - types, importance, data collection tools?
- How RWD has enabled in unveiling the uncertainties during Covid-19 pandemic. Benefits of RWD to patients, providers, payers, and regulators?
- Key considerations in RWD study design, limitations of RWD
- Generating evidence from RWD
Meet the Presenters
Mrunalini Jagtap
Data Management Lead
Singapore Institute for Clinical Sciences (SICS), A*STAR
Mrunalini is an accomplished professional with around 15 years of experience in diverse roles across CRO, IT, pharmaceutical & research organizations where she has exhibited expertise in steering global CDM projects conducted across US, EU & APAC to successful completion. Currently, she is associated with Singapore Institute for Clinical Sciences (SICS) A*STAR as a Data Management Lead.
Singapore Institute for Clinical Sciences (SICS), A*STAR
As a strong advocate of data-driven and lean six sigma methodologies, her key initiatives and contributions viz. optimization and standardization of various data processes, development of integrated CTMS/CDMS platform and system for controlled data sharing are noteworthy. Mrunalini is passionate about keeping herself well informed on the latest trends and technologies, which is reflected in her articles and presentations delivered at various international conferences in Singapore, India, Germany and USA.
She believes that the true value of knowledge and innovation lies in its applications for the betterment of business and life, and this is possible by creating a strong ecosystem involving all stakeholders. Mrunalini is keen to drive collaborative digital transformation programs that will enable organizations to draw valuable insights from the data and make better informed decisions.
Arshad Mohammed
Head of FSP CDM team
Covance
Arshad is a physician by training and brings over 20 years’ experience in the health sciences industry. His early career path has been in acute patient care at a tertiary care center, medical affairs, medico-marketing and in development of a web based online/offline clinical data management system. As his career progressed, Arshad has held a variety of roles in life sciences consulting, software product management, clinical data management, business development and electronic clinical outcomes assessments (eCOA). Currently, Arshad is the Head of FSP CDM team at Covance by Labcorp.
Covance
Aaron Galaznik
Head of Real World Evidence Solutions, AcornLabs Boston
Medidata Solutions
Aaron Galaznik, MD, is the Head of Real-World Evidence Solutions at Acorn AI, a Medidata Company. He has over 10 years of experience in the life sciences industry, with previous roles in Real World Data, Health Economics and Outcomes Research, Market Access and Commercial Analytics at Takeda Oncology and Pfizer. His therapeutic expertise includes oncology, pain, inflammation, respiratory, and cardiovascular disease, and he has multiple publications and presentations on disease burden, clinical outcomes assessment, real-world comparative effectiveness, treatment persistence, and impact of utilization management. He received his AB in Biology from Harvard University, his MD from Weill Medical College of Cornell University, and his MBA in Healthcare Management from the Wharton School.
Medidata Solutions
Zhanna Jumadilova
Vice President
Insmed
Dr. Zhanna Jumadilova, Vice-President and head of Clinical development for Arikayce at Insmed. Zhanna is a physician executive with the experience of organizational and leadership responsibilities in clinical development, medical affairs and HEOR across different therapeutic areas, including rare disease/pulmonary infection, solid tumor oncology/biosimilars, urology and others. She posseses profound knowledge of drug development, pragmatic trial design, RWE. During her years at Pfizer , Zhanna has led strategic imperative on research engagements with Payer Partners and a policy document for pragmatic clinical trials.
Insmed
Earn CEUs
SCDM is authorized by IACET to offer 0.1 CEUs for this education program. Participants are eligible to receive CEUs upon successful completion of the digital assessment questionnaire linked to this session, within 30 days after the purchase of the conference session.
Price
SCDM members: $50
Non-members: $175
Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.
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