Clinical research projects often involve giving patients new treatments, or changing the way that care is delivered. Sometimes treatment costs for patients who are enrolled in research are less, but often there is an excess treatment cost (ETCs). For non-commercial research studies, these costs are the responsibility of the NHS and are funded through normal arrangements for commissioning patient care.
In the past, researchers and funders have found it difficult to get commissioners to agree to pay these costs, although some primary care trusts did develop a transparent process for decision making.
In the new NHS, NHS England's Mandate states that they have a responsibility to:
"ensure that the new commissioning system promotes and supports participation by NHS organisations and NHS patients in research funded by both commercial and non-commercial organisations, most importantly to improve patient outcomes, but also to contribute to economic growth. This includes ensuring payment of treatment costs for NHS patients taking part in research funded by Government and Research Charity partner organisations."
AMRC is concerned that NHS Englands' interim guidance to Clinical Commissioing Groups (CCGs) on paying for experimental treatments allows CCGs to not pay ETCs that they cannot afford or do not consider to represent a good use of resources. It will be hard for researchers to appeal, or for a consistent approach across England.
NHS England have told AMRC that guidance for 2014 will be amended to reflect that ETCs associated with research on the NIHR portfolio and in Biomedical Research centres and units would be met by NHS England.
AMRC is working with NHS England to clarify :
how CCGs will decide whether ETCs will be paid
how this will work when a research project is taking place in more than one CCG area
how studies where ETCs have been agreed by Primary Care Trusts should be dealt with
If you have any examples where ETCs are an issue, please contact our research policy manager Andy.