Understanding and Interpreting Studies Using Real-World Data

Tuesday 22 October 2024
09:30 - 17:00 (GMT)

Evidence generated from clinical observational studies, outside of clinical trials, known as real-world evidence (RWE), is increasingly used to inform decision-making surrounding the use of medicines. The application of RWE is modernising the process of drug discovery, development, post-authorisation safety and effectiveness and outcomes research. The potential for the use of RWE throughout the entire lifecycle of medicines continues to grow.

This one-day course aims to provide an introduction to RWE studies in the context of pharmaceutical medicine.


This one-day course is delivered by DSRU for FPM.

What will we cover?

  • Basic principles and value of real-world data in pharmaceutical medicine and research
  • Strengths and challenges of using real-world evidence and its use in medical research
  • Real-world evidence in drug safety
  • Current and future applications of real-world evidence

Who should attend?

This full-day course will be introductory; no pre-requisites are required. It is suitable for:

  • Pharmaceutical physicians working in the field of pharmaceutical medicine
  • Physicians and scientists new to the pharmaceutical industry or looking to transition to the pharmaceutical industry
  • Those working in pharmaceutical industry without medical / life sciences backgrounds

Speakers

Professor Saad Shakir MB ChB LRCP&S FRCP FFPM FISPE FISoP MRCGP 
Director of the DSRU

Debabrata Roy PhD 
Head of Epidemiology and Research at the DSRU

Samantha Lane MSc 
Head of Research at the DSRU Centre for Pharmacovigilance Science

 

Find out more below


Where is this workshop taking place?

This 1-day course is being delivered in a Hybrid format. At the checkout, you have the option of selecting an in-person ticket or an online ticket.

The course will be delivered in person at the Faculty of Pharmaceutical Medicine.

You can find us here:

19 Angel Gate,
326a City Road,
London
EC1V 2PT

If you cannot attend in person, you can join us online via Zoom. Joining instructions will be emailed to attendee’s registered e-mail address, with a reminder sent shortly before the event.

Queries: If you are unable to complete your booking online or have any questions, please email training@fpm.org.uk.

Please see our Terms and Conditions and Privacy Policy.

Details

This event will take place online and in person on:

Tuesday 22 October 2024 09:30-17:00 (GMT)


Price options:

In person FPM member fee £175
In person non-Member fee £225

Online FPM member fee £150
Online non-member fee £200

Reduced rates are available for FPM members who fulfil one of the following criteria: PMST trainees, People from low and lower-middle income countries, Unemployed, Part-time employed (earning less than £15,000 per year), People on Parental Leave, Junior Doctors. Contact training@fpm.org.uk to find out more.
Booking closes on Friday 18 October at 12pm.
Please see our booking terms and conditions and our privacy policy

CPD Credits

You can find instructions and guidance regarding CPD eligibility here.

Approve for CPD

 

Agenda

TimeSession Title
09:30 Welcome
09:45 Basic principles and value of RWD (FPM and Saad Shakir)
  • Value of RWE in biomedical research
  • Limitations of RCTs
  • How RWD fills the gaps
10:45 Break
10:50 Principles of observational research (Saad Shakir)
  • Bradford Hill criteria
  • Strengths and challenges of using RWE
  • Limitations, including bias and confounding, and missing data
  • Selection of real-world data source(s)
11:50 Coffee break
12:05 Real-World Evidence in Drug Safety: Methods and Data Sources (Samantha Lane)
  • Study designs
  • Data sources
  • Samples in pharmacoepidemiology
    • Considerations for sample size
    • Generalisability
12:50 Q&A
13:00 Lunch
14:00 Real-World Evidence in Drug Safety: Methods and Data Sources (Samantha Lane)
  • Statistical analysis in pharmacoepidemiology
    • 2x2 table
    • Statistical approaches
    • Causal inference
  • Interpretation of study results (including statistical significance and confidence intervals)
14:45 Break
14:50 Current and future applications of RWE (Debabrata Roy)
  • Current uses of RWE
    • Post-authorisation Safety Studies (PASS)
    • Post-authorisation Efficacy Studies (PAES)
    • Risk minimisation
    • Drug Utilisation Studies
  • Uses of RWE in outcomes research
    • Value of RWE for this purpose
    • Uses of RWE outcomes research in pharmaceutical medicine
15:35 Coffee break
15:50 The future of RWE (Debabrata Roy)
  • The use of RWE in expedited authorisations/ approvals
  • Advances in the generation of RWE
16:35 Panel discussion/Q&A and Closing Remarks (Saad Shakir)

Meet the Speakers

Prof Saad Shakir MB ChB, LRCP&S FRCP FISPE MRCGP
Director,Drug Safety Research Unit

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit in Southampton.

The DSRU is an academic unit associated with the University of Portsmouth. At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations. He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.  Saad serves as a Chairman or member of Safety Advisory Boards and Data Safety Management Committees. He is an author of many book chapters and publications in scientific journals on pharmacovigilance, pharmacoepidemiology and risk management and is a member of the editorial boards for the journals Drug Safety and Pharmacoepidemiology and Drug Safety.

Saad Shakir has led and co-ordinated many post graduate educational and training programmes including the MSc programme in Pharmacovigilance at the DSRU. He supervises post graduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London; a Fellow of the Faculty of Pharmaceutical Medicine; a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the UK.

Email: saad.shakir@dsru.org


Debabrata Roy
Head of Epidemiology, Drug Safety Research Unit

Debabrata is a Pharmacoepidemiologist and the Head of Epidemiology and Research at the DSRU, joining in 2015. He is also an Honorary Associate Professor in the School of Pharmacy and Biomedical Sciences at the University of Portsmouth. He has a pre-clinical research background and holds a BSc in Pharmacology (University College London), an MSc in Drug Discovery Skills (King’s College London) and completed his PhD in Neuroendocrinology from Imperial College London. He has trained in Epidemiology, gaining an MSc from Imperial College London and in Pharmacovigilance (PgD) from the University of Portsmouth.

Debabrata has oversight of and leads a team conducting Real-World Evidence (RWE) drug safety studies utilising Real-World Data. This includes study design, methodology and the statistical analysis of Post-Authorisation Safety Studies (PASS) involving Modified-Prescription Event Monitoring (M-PEM), Specialist Cohort Event Monitoring (SCEM), Active Surveillance, Registries and Clinical Practice Research Datalink (CPRD) database studies, as well as systematic Benefit-Risk assessments and systematic reviews.

Debabrata is also a Vaccine monitoring Collaboration for Europe (VAC4EU) Executive Board member, Associate Editor with Therapeutic Advances in Drug Safety and a CPRD Expert Review Committee member.


Samantha Lane
Senior Research Fellow (Research and Innovation) / Head of Research at the DSRU Institute for Pharmacovigilance and Pharmacoepidemiology Sciences, Drug Safety Research Unit, UK

Samantha is a Senior Research Fellow and Epidemiologist at the DSRU, having joined in 2017. She has a background in biomedical science and holds an MSc in Medical Microbiology (University of the West of England) and an MSc in Epidemiology (London School of Hygiene and Tropical Medicine). She has also completed the PgD in Pharmacovigilance from the University of Portsmouth.

Samantha is heavily involved in both methodological research and pharmacoepidemiological studies. She has experience with study design and data analysis, including the analysis of electronic health records data from the CPRD database, and has also been involved with conducting systematic benefit/risk assessments.

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The views, information, or opinions expressed during FPM events and training are those of the individuals involved and do not necessarily represent those of the Faculty of Pharmaceutical Medicine. We value inclusivity, equality and diversity, and work hard to promote these whenever possible in all of our activities. We welcome your comments and feedback: events@fpm.org.uk