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Table 3 Details of the outcomes of internal pilots

From: A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

Changes made to the design of the main trial? (Yes/No) Frequency (%)
Yes, conduct of recruitment 10 (18%)
Inclusion criteria widened 2 (20%)
Increased number of sites 2 (20%)
The predicted recruitment rate for the rest of the trial was amended 1 (10%)
Recruitment extended for the main trial 1 (10%)
Reduced the number of arms in the trial and the sample size 1 (10%)
TSC recommended sample size re-estimation given observed complication rate difference 1 (10%)
Simplified of inclusion/exclusion criteria; shortened of case report forms 1 (10%)
Widened inclusion criteria; increased number of sites 1 (10%)
Yes, impact on outcome data 1 (2%)
Clarifications made to the protocol; flexibility added to location of outcome assessments 1 (100%)
Yes, in terms of both recruitment and outcome data 1 (2%)
Change of eligibility criteria; change to secondary outcomes; inclusion of a sub-trial 1 (100%)
Yes, no further information given 2 (4%)
No 43 (75%)
Total 57 (100%)
  1. TSC Trial Steering Committee