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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