Understanding Disease through Mining Clinical Trial Data

Standard measures of human physiology are no longer enough to guide the next generation of medicines. Advances in technology are enabling the generation of new data types with finer granularity and more dimensions in information content. A deeper understanding of disease is arising from molecular data generated on biospecimens from patients enrolled in clinical trials. Further understanding of disease and drug response may be achieved with continuous physiologic readouts using biosensor technologies. These data will drive target selection, patient stratification and understanding of therapeutic and adverse responses.

This technical meeting will cover the following topics:

– Ability to capture novel data types in a clinical trial, e.g. biosensor data, smart phone data

– Clinical Sample Data: Types and Analytical Methods/Models

– Workflows and processes for enabling the integration of clinical and molecular data

– Approaches that companies are following to enable broad re-use of data

– Analysis environment for the primary and secondary use of such data

– Bioethical (legal and privacy) and regulatory requirements for working with such data

– Example of data management by a company in another industry with similar data challenges

A PRISME Forum Technical Meeting Advisory Committee (TMAC) has been set up to provide guidance on agenda topics and appropriately qualified speakers.

The committee members are listed below:

The PRISME Forum Technical Meeting Advisory Committee will be looking for qualified speakers to address relevant topics including:

• Use cases:
  • demonstrating how new clinical trials paradigms can bring demonstrable value
  • from other industry sectors to gain new insights into data sharing and pre-competitive collaborations
• Strategies for the deployment of mobile devices and/or wearables addressing data standards and regulatory compliance
• Next Generation Clinical Trials Data Management – including data sharing, data provenance and metadata management
• Secondary use of Clinical Trials data
• Patient-centric approaches to the new clinical trials paradigms including privacy and ethics
• The global clinical trials environment and the need to conform with different laws and regulations

PRISME Forum members will be able to identify and define new clinical trials opportunities (including technologies, services and business models) that can impact R&D in their parent companies and find opportunities to partner to deliver pre-competitive capabilities that increase the effectiveness of their bio-pharma R&D.

For more information or for any suggestions, please get in touch with John Wise, Programme Coordinator for the PRISME Forum: jcmwise@prismeforum.org or +44 7768 173518.