What - This lecture series provides basic elements of methodology of research, with a special focus on biomedical research effectiveness in innovating clinical practice. Rather than being exhaustive on methodology, we target critical gaps that typically hurdle the translation and implementation of promising compounds or procedures. Attendees will learn how to avoid such gaps in their own research, or to assess the actual value and faults of papers promoting new findings, and to ask precise questions in order to obtain the target evidence required to concretely support and innovate their clinical practice.
Why – The failure rate of current drug development at the first check-point (approval by regulators) ranges between 76-93% among medical fields [1]. The failure rate of biomarker qualification procedures alone, ever submitted to the European Medicine Agency (EMA) in any medical field, is 85% [2]. Most failures are due to early translational steps. Consequently, failure on the overall translational pipeline is even higher. To concretely improve patient care, we need greater awareness about proper research methodology at all development steps, by all parties (researchers, clinicians, publishers, funders).
How – We offer a starting series made of few lessons, meant to be highly interactive in order to build this course based on actual needs. In this way, we can understand what is most useful to the audience, what is most difficult or unclear, and how to improve or what to integrate for a next series.
Where – online (link will be provided).
When – On Tuesdays, h 12.00, from October 17, 2023.
References
1. Thomas DC, et al. Clinical Development Success Rates and Contributing Factors 2011–2020. In. https://www.bio.org/clinical-development-success-rates-and-contributing-factors-2011-2020: BIO, Informa Pharma Intelligence, and QLS Advisors 2021.
2. Bakker E, et al. Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020. Clinical pharmacology and therapeutics 2022.
