Today, the report was released from the workshop: Optimising the design of clinical trials for advanced therapies
The event was co-organised by the Advanced Therapy Treatment Centre network, the Association of the British Pharmaceutical Industry, UK Bioindustry Association and the Cell and Gene Therapy Catapult in partnership with the Advanced Therapies Network and London Advanced Therapies. Approximately eighty guests attended drawn from the National Health Service, academia, industry and government regulatory agencies.
The event consisted of talks, panel discussions and a breakout session to present multiple aspects of the design and execution of clinical trials in this complex landscape. Major messages from the day were:
- To engage early with competent authorities, especially regarding innovative trial designs early. The authorities are willing to guide companies before a trial design is formally locked down
- Establish interdisciplinary teams within facilities to improve the execution of clinical studies
- Include health related quality of life measures in early phase studies to build data for reimbursement.
To access the report, click here