The conventional pathway of drug development has been successful for many years and is still a viable model/ framework to develop medicines for certain diseases. It is now generally accepted however, that the hugely increasing cost of drug development has not been reflected in a similarly large increase in the number of new medicines.
Additional techniques and approaches need to be explored to expand the range of methods available to develop new medicines. Some of the issues facing drug development include:
The high rate of loss of potential new drugs.
For every 25,000 compounds that start in the laboratory, 25 are tested in humans, 5 make it to market and only one recoups what was invested. It has been noted that there is a particular problem in the transition from small scale Phase II to the much larger Phase III clinical trials.
Moving from the expectation of testing medicines in large groups of similar individuals towards testing in relevant populations which the medicine is designed to treat.
The rigidity of the conventional drug development process – we need to have a wider variety of methods that we can use to develop new medicines as well as a more flexible regulatory framework.
Simplifying the regulatory and governance framework for performing clinical research while maintaining standards, as recommended in the 2011 Academy of Medical Sciences review: A new pathway for the regulation and governance of health research.
An increasing number of medicines are licensed for use (i.e. approved as safe and effective) but doctors are not able to prescribe them through the NHS because the Government has not agreed to pay for them (i.e. they are not reimbursed). There are various reasons for this but the overall result is a disincentive to the development of innovative medicines.
New techniques and approaches.
There are various ways that industry, regulators and academia are working to try and remedy this situation:
A flexible drug development process
Value and outcomes evaluation in trial design