About
Evidence-based medicine (EBM) hierarchically organizes different sources of medical information with meta-analyses, systematic reviews, and randomised clinical trials (RCTs) which provide the strongest and most reliable evidence and patient registries which fall under observational studies classified as a source of low-level evidence.
RCTs, the golden standard of medical evidence, are meant to generate unbiased data for inferring causality from observed associations whereas the observational studies are often seen as delivering poor quality information. However, the reality is not always so clear and straightforward. The main concern related to RCTs as guidance in medical decision-making is their applicability to daily clinical practice and generalisability to a patient population at large.
Real-world data (RWD) refer to any observational data collected outside of clinical trials or clinical investigations. Patient registries, belonging to the RWD family, are gaining in importance as a source of medical information. Therefore, it is critical to understand the specificity of such data and the way they should be interpreted.
This course focuses on the basic concepts of real-life medical research, the differences between the data from real-life settings including patient registries and experimental trials, and their relevance in clinical context. It will additionally provide tools for critical appraisal of the published registry data.
Module 1 – Principles of RWD and RWE
- Definitions
- Sources
- Utilization
- Stakeholders
- Basics of medical research: clinical trials vs. observational studies
Module 2 – Patient registries
- Definition and basic principles of patient registries
- Purposes
- Types of registries
- Current uses
- Critical appraisal of published patient registry data
- Exercise
This course addresses individuals from pharmaceutical and medical device companies primarily medical affairs, clinical, operations, medical science, R&D, market access and pharmacovigilance. Additionally, it will be beneficial for national health service decision-makers, payers, clinicians, medical doctors, health care professionals, and anyone who is interested in real-world utilization of health care services.
Participant experience
Participants should have general understanding of drug development and clinical research relating to medical interventions. No specific experience required.
The course will consist of lectures, discussions and hands-on exercises.
Lecturers
Maria Koltowska-Häggström
After completing her medical studies in Wrocław, Poland, Maria worked for ten years as a paediatrician. In 1991, she began working within the pharmaceutical industry where she gained experience in both the marketing and medical sides of the business. Between 2001 and 2013, Maria worked at Pharmacia (later Pfizer) in Stockholm, Sweden, where she held various responsibilities for large patient registries. She was a leading member of numerous research groups investigating growth hormone disorders in paediatric and adult patients managed in the real-life clinical setting. She has an extensive track record of patient registry research and lectured at multiple meetings related to patient registries, late-phase drug development, data management, drug safety evaluation, and QoL research.
She earned PhD at Uppsala University, Sweden, based on patient registry studies of QoL in adult patients with growth hormone deficiency.
She is a vice-president of the European Medical Writers Association (EMWA), and a member of European Association of Scientific Editors (EASE), European Society of Endocrinology (ESE), and Growth Hormone Research Society (GRS). Additionally, as a long-time EMWA member, Maria is a trainer and a workshop leader, section editor for Medical Writing, and a chair of the Expert Seminar Series Organizing Committee.
This online training is divided in 2 modules:
Module 1 | 06 November 2023 from 2:00 pm to 6:00 pm CET
Module 2 | 08 November 2023 from 2:00 pm to 6:00 pm CET
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 880,00* (until 16 October 2023)
Ordinary: € 1.070,00*
Freelance – Academy – Public Administration**: € 570,00*
*for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
