The Role and Standardisation of Expanded Access Chemotherapy Programmes in a Designated Irish Cancer Centre
Expanded access is where pharmaceutical companies provide early access to unauthorised medicines that are not yet publicly available to cancer patients who may benefit from them. These medicines have been proven to be safe and effective through clinical trials but have not yet been brought to market. In these cases, a patient may be allowed access to such medicines on an expanded access basis from a pharmaceutical company.
In many countries throughout Europe and in the US, available expanded access programmes are regulated and maintained by national bodies. As such, access to them is harmonised across the respective countries to expedite and manage their use in patients who may require them. In Ireland however, there is no standardised protocol for their use and therefore relies on individual applications from oncologists and haematologists to pharmaceutical companies to obtain these treatments for their patients. As a result, little is known about the role they play in current cancer treatment within Ireland.
What I aim to do as part of this project therefore is to create a repository of available programmes in Ireland as it stands without such a centralised national approach. This repository will allow for greater awareness of available programmes amongst oncologists and haematologists and will begin the first steps towards creating a nationwide expanded access programme protocol to manage and monitor their use in cancer patients in Ireland more effectively.
The goal is that these programmes will be more readily available to patients who need them and as a result will improve cancer patient outcomes into the future.Back