Enhancing confidence in the data used to make decisions in first in human studies
First in human studies represents a critical milestone in drug development – the first opportunity to assess the human potential of the medicine. It is also the stage of development during which we are most dependent on pre-clinical data to inform clinical decisions, such as the doses to be given and safety parameters to be measured. Reliability of data is vital to the drug development process and the protection of volunteers and patients in that process. There are multiple aspects to reliability of data. In this workshop we will focus on one aspect in particular - reproducibility.
Who should attend:
- Drug developers - both those in Industry and Academia. Hear about examples of best practice and how to ensure your datasets can be robust.
- Clinicians and medical students. An increasing proportion of first in human studies are being conducted directly into patients - what should you be looking for in the dataset to keep your patients safe?
- Funders of research and drug development. Attrition remains high in early development - how can you ensure the research you support is as robust as possible
Professor Tim Higenbottam, President of the Faculty of Pharmaceutical Medicine
Professor Duncan Richards, Climax Professor of Clinical Therapeutics at the University of Oxford
Dr Martin-Immanuel Bittner, Co-Founder & CEO of Arctoris Ltd
Professor Malcolm Macleod, Professor of Neurology and Translational Neuroscience and Academic Lead for Research Improvement and Research Integrity at the University of Edinburgh