PMID- 16956770
OWN - NLM
STAT- MEDLINE
DCOM- 20070327
LR  - 20151119
IS  - 1040-8428 (Print)
IS  - 1040-8428 (Linking)
VI  - 61
IP  - 1
DP  - 2007 Jan
TI  - A web-based study concept designed to progress clinical research for 'orphan' 
      disease areas in haematological oncology in the elderly: the SHIELD programme.
PG  - 79-83
AB  - 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.
FAU - Proctor, S J
AU  - Proctor SJ
AD  - Academic Haematology, Medical School, Newcastle University, Newcastle upon Tyne, 
      NE2 4HH, UK. s.j.proctor@ncl.ac.uk
FAU - Wilkinson, J
AU  - Wilkinson J
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20060907
PL  - Netherlands
TA  - Crit Rev Oncol Hematol
JT  - Critical reviews in oncology/hematology
JID - 8916049
SB  - IM
MH  - Activities of Daily Living
MH  - Aged
MH  - Aged, 80 and over
MH  - *Biomedical Research
MH  - Clinical Trials as Topic
MH  - Comorbidity
MH  - *Hematologic Neoplasms
MH  - Hodgkin Disease
MH  - Humans
MH  - *Internet
MH  - Middle Aged
MH  - Practice Patterns, Physicians'
MH  - *Rare Diseases
MH  - *Registries
EDAT- 2006/09/08 09:00
MHDA- 2007/03/28 09:00
CRDT- 2006/09/08 09:00
PHST- 2006/04/30 00:00 [received]
PHST- 2006/06/30 00:00 [revised]
PHST- 2006/07/06 00:00 [accepted]
PHST- 2006/09/08 09:00 [pubmed]
PHST- 2007/03/28 09:00 [medline]
PHST- 2006/09/08 09:00 [entrez]
AID - S1040-8428(06)00133-8 [pii]
AID - 10.1016/j.critrevonc.2006.07.002 [doi]
PST - ppublish
SO  - Crit Rev Oncol Hematol. 2007 Jan;61(1):79-83. doi: 
      10.1016/j.critrevonc.2006.07.002. Epub 2006 Sep 7.