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Table 1 Characteristics of STAMPEDE and FOCUS4

From: Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons

Trial characteristic STAMPEDE FOCUS4
Disease setting Prostate cancer Colorectal cancer
Registration numbers
 ISRCTN ISRCTN78818544 ISRCTN90061546
 EudraCT 2004-000193-31 2012-005111-12
 ClinicalTrials.gov NCT00268476 Not available
Date first patient randomised October 2005 January 2014
Multiple comparisons Yes Yes
Multi-stage elements Yes Yes
Comparisons for specific sub-groups (stratified elements) Yes (defined by metastases; diabetic status)
Pending (defined by biomarker)
Yes (defined by biomarker)
Shared control arm Yes No
Initial comparisons open 5 2
New research comparisons added 5 3
Research comparisons closed for lack of benefit 2 1
Research comparisons reached recruitment target 6 Pending
Eligibility criteria revised Yes Yes
Stratification criteria revised Yes Yes
New biomarker classifications added Pending Yes
Updates of standard of care 3 0
Patients recruited so far > 10,000 > 900
Data collected on paper CRFs Yes Limiteda
Data entered from source notes straight into database No Yes
Data entry Staff at CTU Staff at sites (excepta)
Randomisation Sites call CTU to randomise Sites call CTU to randomise
  1. Abbreviations: CRFs Case report forms, CTU Clinical trials unit, FOCUS4 Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trial programme, STAMPEDE Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
  2. aRegistration, biomarker collection and serious adverse events