A web-based study concept designed to progress clinical research for 'orphan' disease areas in haematological oncology in the elderly: the SHIELD programme.

Clinical randomised trials (RCT) in elderly populations with haematological malignant disease are rare and difficult to perform. This paper describes the methodology and process of organising an internet-based international programme for Hodgkin's lymphoma in the >60 years age group in a format which is compliant with the European Clinical Trials Directive (EUCTD). International agreement was obtained on the need for a web-based data collection system for basic registration and evaluation which incorporated an electronic case report system (eCRF) for a Phase II Study. Objective assessments of co-morbidity, activities of daily living (ADL) and instruments of daily living (IADL) were built-in to define objective frailty, linked to physician treatment choice or inclusion on the Study protocol. The programme is now operating effectively in the UK and Germany and provides an organisational model of how research in 'orphan' disease areas of haematological and solid tumour oncology, previously considered very difficult, might be overcome.