IRCI is a joint initiative between Cancer Research UK (CRUK), the National Institute of Health Research Clinical Research Network: Cancer (NIHR CRN:Cancer), the National Cancer Institute (NCI), the European Organisation for Research and Treatment of Cancer (EORTC), the Institut National Du Cancer (INCa) and the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG).

The aim of this initiative is to facilitate the development of international clinical trials for patients with rare cancers in order to boost the progress of new treatments for these patients.  The initiative hopes to encourage the use of innovative methodologies to maximise the potential for answering research questions and to identify and overcome barriers to international trials to allow international collaborative trials to run smoothly.

Criteria for inclusion in the IRCI programme

Rarity

A fixed rarity cut-off is not applied, but as a guide cancers with a total incidence of less than 2/100,000 have been considered for inclusion in the IRCI programme.  Occasionally, rare clinical scenarios have also been considered.  To date, IRCI has excluded rare molecular sub-types of common cancers, simply because this embraces most of cancer. However, a rare molecular sub-type could be considered if it is a distinct, prospectively identifiable rare sub-group with a strong rationale for separate research, rather than inclusion as a molecular stratum in a mainline trial.

Lack of existing trials

IRCI exists to develop new trials where there is no (or minimal) existing trial data and no existing trial.  It is not intended to compete with (or boost) existing trials.

Potential for an interventional trial

Priority is given to cancers with potential for an interventional – usually randomised – trial (not an audit, registry or non-trial tissue collection).  There needs therefore to be research treatments of genuine interest for investigation, and sufficient patients for an international trial to be feasible.

Enthusiastic champions

Enthusiastic commitment from investigators to propose trial ideas and act as Principal Investigators is essential.