Introduction to Clinical Trials (2-days online workshop)

Clinical trials remain the gold-standard studies for developing and testing new therapeutic drugs before their eventual deployment to drug market and national health systems. They are typically very costly for pharmaceutical companies and research community alike. As such, clinical trials follow a strict set of standards to increase their replication and reproducibility while avoiding overconfident and biased reporting and the wasting of precious resources. These strong standards are deeply rooted in the scientific method in order to have sound design (e.g., sample size calculations), execution (e.g., masking/randomization), analysis (e.g., survival analysis) and reporting (e.g., CONSORT guidelines). This workshop aims at presenting and discussing these standards at the core of clinical trials. The content of the course will be delivered in a learning setting where theoretical knowledge is consolidated with the execution of many practical exercises taken from real clinical trials in which the tutor was directly involved. The practical exercises will be conducted in the R software (or R studio) with the requirement of a basic knowledge of the respective language. By the end of workshop, the attendees are expected to know how to design a basic clinic trial, to execute it, to interpret and to report the respective data in an objective and unbiased way. Given the generality of the methodology associated with clinical trials, the attendees are also expected to improve their general skills in the design, execution, analysis and interpretation, and reporting of any scientific study.  

Date: February 27 and 28, 2025, 10:00 a.m. – 3:00 p.m. (2-days online workshop).

Time: 10 hours (5 hours each day with a coffee break).

Location: online.

Group: for a group larger than 3 persons.

Teacher: Nuno Sepúlveda, Ph.D.

Price: 380 EUR/USD (plus VAT if applicable).

Methods of payment: wire transfer.

Topics:

  • Clinical Trials and the Scientific Method
  • Phases and design of Clinical Trials
  • Primary and secondary endpoints
  • Masking and randomization
  • Power calculation and sample size determination
  • Statistical analysis with special emphasis on survival analysis
  • CONSORT standard for reporting

Nuno Sepúlveda, Ph.D.

Assistant Professor from the Faculty of Mathematics & Information Science at the Warsaw University of Technology where he teaches biostatistics and other courses. Previously, he worked as a research fellow in statistical genetics and genetic epidemiology of Malaria and then as an Assistant Professor of Epidemiology and Biostatistics in the Department of Infection and Immunology (now the Department of Infection Biology), Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine. Nuno has more than 20 years of experience in the field of applied statistics and has more than 150 peer-reviewed publications in journals, such as Nature Genetics, PLoS Genetics, Lancet Infectious Diseases, Lancet Hematology, and Science Translational Medicine. His current research interest is the application of statistical and machine learning techniques to investigate the pathogenesis of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis and long COVID with the special emphasis on genetic, epigenetic and serological data. Currently, he holds a Horizon Europe Widera Grant in a EU-funded project (PvSTATEM) aiming to perform two clinical trials on malaria control in Ethiopia and Madagascar. He is also Associate Editor of Frontiers in Medicine (Infectious Diseases: Pathogenesis and Therapy) and Frontiers in Public Health (Infectious Diseases: Epidemiology and Prevention).

 

Date

27-02-2025 to
28-02-2025
 

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