Introduction of New Medicine
The "introduction of new medicine" provides a natural and potentially rich source for Longevity Catalysts.
As such, this section sets out the current protocols around such an introduction.
There are stringent controls in place regarding the introduction of any medicine into clinical practice, and each must demonstrate its efficacy and safety through a series of clinical trials:
Phase 1 trials involve healthy volunteers and determine whether a medicine works in humans and the appropriate dosage range.
Phase 2 trials involve a small group (100 - 300) of patients with the targeted condition.
Phase 3 trials involve a large group (1000 - 3000) of patients with the targeted condition to determine whether the medicine is both safe and effective.
Sponsors of clinical trials in the UK must recruit investigators, develop a suitable protocol and demonstrate to the UK Medicines and Healthcare products Regulatory Agency that there is a reasonable hypothesis underlying the clinical trials and that pre-clinical results including animal studies warrant further research.
The full process of obtaining a licence for a new medicine can be "fast tracked" but may equally take up to around12 years. As such, those medicines that will be introduced into clinical practice in the short to medium term are already likely to undergoing clinical trials.
See also Mortality Improvement Framework.
Source: Disease and Death; Improving our understanding of the future by Hande Love and Daniel Ryan