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Table 2 The characteristics of the studies identified in Cortellis (by IDRAC number) that mentioned the use of forced randomization (FR)

From: Forced randomization: the what, why, and how

IDRAC Number

Study name [main publication reference]

ClinicialTrials.gov identifier

Country/ Region

Document Type

Sample size

Allocation ratio

Stratification

Block size

Number of FRs

% FRa

363,676

ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection (ECOSPORIII)

[17]

NCT03183128

USA

Original Approval - BLA

182

1:1

2 strata, 2 levels

unavailable

6

3.30%

304,185

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

[18]

NCT01499563

USA

Original Approval - NDA

335

1:1:1:1

none

unavailable

11b

3.28%

308,579

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

[19]

NCT01243424

USA

Supplemental Approval - NDA

6033

1:1

by center

unavailable

98

1.62%

137,950

Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

[20]

NCT00373958

USA

Meeting

666

1:1

by center

unavailable

3

0.45%

234,486

A Study of MK-6072 and MK-3415 A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415 A-002) (MODIFY II)

[21]

NCT01513239

USA

Original Approval - BLA

1168

1:1:1

2 strata, 4 levels

unavailable

Not reported

--

A Study of MK-3415, MK-6072, and MK-3415 A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415 A-001) (MODIFY I)

[21]

NCT01241552

1412

1:1:1:1

2 strata, 4 levels

unavailable

Not reported

--

351,428

A 12-Month Phase 3 Study of Pasireotide in Cushing’s Disease

[22]

NCT00434148

European Union

EPAR

165

1:1

1 stratum, 2 levels

unavailable

1

0.61%

362,467

Placebo-Controlled Randomized Trial of Adjuvant Imatinib Mesylate Following the Resection of Localized, Primary Gastrointestinal Stromal Tumor (GIST)

[23]

NCT00041197

European Union

EPAR

773

1:1

1 stratum, 3 levels

unavailable

60

7.76%

361,985

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (RE-COVER I)

[24]

NCT00291330

European Union

EPAR

5331

1:1

2 stata, 4 levels

4

18

0.34%

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs. Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (RE-COVER II)

[25]

NCT00680186

370,472

Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)

[26]

NCT02696031

European Union

EPAR

555

1:1:1

1 stratum, 3 levels

6

2

0.36%

  1. a%FR is calculated as the number of reported forced randomizations (using the definition that a manual mis-dispensation is not considered a forced randomization) divided by the total number of randomized patients
  2. bIn addition, this study had 4 manual mis-dispensations that were not included in our calculation of %FR
A total of 9 submission documents were found. One submission (IDRAC number 234486) included two studies, MODIFY I (ClinicalTrials.gov: NCT01513239) and MODIFY II (ClinicalTrials.gov: NCT01241552), and mentioned the use of FR without providing further details on the actual number of FRs in these studies. Another submission (IDRAC number 361985) was based on the pooled data from two studies, RE-COVER (ClinicalTrials.gov: NCT00291330) and RE-COVER II (ClinicalTrials.gov: NCT00680186); therefore, the reported values (sample size, number of FRs, etc.) are based on the pooled data from these two studies
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BMC Medical Research Methodology

ISSN: 1471-2288

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