Value and outcomes evaluation in trial design

After a product has been granted a Marketing Authorisation (i.e. after a regulatory authority has deemed the medicine to be safe and effective), a separate decision is then taken on whether it should be reimbursed. 

The decision on reimbursement status is taken by bodies such as the National Institute for Health and Clinical Excellence (NICE) in the UK, via the Health Technology Assessment (HTA) process. 

It would be beneficial for health outcomes for patients to be considered earlier in the drug development process. Clinical trial design could be modified so that data on value and health outcomes for patients can be collected earlier for the HTA assessment, as well as safety, efficacy and manufacturing quality data for the Marketing Authorisation application. 

These two processes have been traditionally kept separate, extending the drug development pathway. However further discussions are now underway to determine new development pathways going forward.

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