Background
Methods
Search strategy
Inclusion criteria
Data extraction and analysis
The following details were extracted from eligible articles: |
---|
Section 1: Trial details |
1.1. Title |
1.2. Authors |
1.3. Journal |
1.4. Funding body |
1.5. Year of publication (for HTA series only) |
1.6. Rationale of trial |
Section 2: Trial design |
2.1. Recruitment setting, e.g. primary |
2.2. Type of trial, e.g. parallel |
2.3. Number of trial arms |
2.4. Number of primary outcomes |
2.5. Type of primary outcome, e.g. subjective |
2.6. Unit of randomisation |
2.7. Blinding |
(i) Level of blinding |
(ii)Reasons provided for non-blinding or level of blinding |
Section 3: Sample size |
3.1. What was the estimated sample size? |
3.2. Was the estimated sample size obtained? |
Section 4: Trial stopping |
4.1. Did the trial stop early? If yes, give details of why and how this decision was made |
Section 5: Oversight committee reporting |
5.1. If TSC reported |
(i) Are the TSC members listed at the end of the paper? |
a. Name of committee |
b. Number of members |
c. Number of voting members |
d. Chair indicated |
e. Details regarding the number of members by role and by voting rights if applicable |
(ii) Is the TSC discussed in the main body of the paper? If yes, give details |
5.2. If DMC reported |
(i) Are the DMC members listed at the end of the paper? |
a. Name of committee |
b. Number of members |
c. Number of voting members |
d. Chair indicated |
e. Details regarding the number of members by role and by voting rights if applicable |
(ii) Is the DMC discussed in the main body of the paper? If yes, give details |
5.3. If applicable, has the absence of committees been justified? If yes, give details |
Results
Eligible cohort and demographics
Journal (N in cohort) | Total (N = 264) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
BMJ (N = 16) |
NEJM (N = 55) |
Lancet (N = 66) |
HTA (N = 127) | |||||||||
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% | |||
Trial rationale | Explanatory | 0 | 0.0 | 0 | 0.0 | 5 | 7.6 | 2 | 1.6 | 7 | 2.7 | |
Pragmatic | 6 | 37.5 | 2 | 3.6 | 10 | 15.2 | 88 | 69.3 | 106 | 40.2 | ||
Not specified or clear | 10 | 62.5 | 53 | 96.4 | 51 | 77.3 | 37 | 29.1 | 151 | 57.2 | ||
Funder origin | Asia | 0 | 0.0 | 1 | 1.8 | 3 | 4.5 | 0 | 0.0 | 4 | 1.5 | |
Japan | 0 | 0.0 | 1 | 1.8 | 2 | 3.0 | 0 | 0.0 | 3 | 1.1 | ||
South Korea | 0 | 0.0 | 0 | 0.0 | 1 | 1.5 | 0 | 0.0 | 1 | 0.4 | ||
Australia | 1 | 6.3 | 2 | 3.6 | 3 | 4.5 | 0 | 0.0 | 6 | 2.3 | ||
Australia | 1 | 6.3 | 2 | 3.6 | 2 | 3.0 | 0 | 0.0 | 4 | 1.5 | ||
New Zealand | 0 | 0.0 | 0 | 0.0 | 1 | 1.5 | 0 | 0.0 | 2 | 0.8 | ||
Europe | 14 | 87.5 | 21 | 38.2 | 40 | 60.6 | 127 | 100.0 | 202 | 76.5 | ||
Belgium | 0 | 0.0 | 1 | 1.8 | 0 | 0.0 | 0 | 0.0 | 1 | 0.4 | ||
Denmark | 3 | 18.8 | 2 | 3.6 | 0 | 0.0 | 0 | 0.0 | 5 | 1.9 | ||
Finland | 1 | 6.3 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 0.4 | ||
France | 0 | 0.0 | 2 | 3.6 | 5 | 7.6 | 0 | 0.0 | 7 | 2.7 | ||
Germany | 0 | 0.0 | 1 | 1.8 | 6 | 9.1 | 0 | 0.0 | 7 | 2.7 | ||
Ireland | 1 | 6.3 | 0 | 0.0 | 2 | 3.0 | 0 | 0.0 | 3 | 1.1 | ||
Netherlands | 2 | 12.5 | 1 | 1.8 | 2 | 3.0 | 0 | 0.0 | 5 | 1.9 | ||
Spain | 0 | 0.0 | 0 | 0.0 | 1 | 1.5 | 0 | 0.0 | 1 | 0.4 | ||
Sweden | 0 | 0.0 | 0 | 0.0 | 1 | 1.5 | 0 | 0.0 | 1 | 0.4 | ||
Switzerland | 1 | 6.3 | 4 | 7.3 | 3 | 4.5 | 0 | 0.0 | 8 | 3.0 | ||
United Kingdom | 6 | 37.5 | 9 | 16.4 | 19 | 28.8 | 127 | 100.0 | 161 | 61.0 | ||
Other (European Union) | 0 | 0.0 | 1 | 1.8 | 1 | 1.5 | 0 | 0.0 | 2 | 0.8 | ||
North America | 1 | 6.3 | 30 | 54.5 | 20 | 30.3 | 0 | 0.0 | 51 | 19.3 | ||
Canada | 0 | 0.0 | 1 | 1.8 | 0 | 0.0 | 0 | 0.0 | 1 | 0.4 | ||
United States of America | 1 | 6.3 | 29 | 52.7 | 20 | 30.3 | 0 | 0.0 | 50 | 18.9 | ||
Not specified | 0 | 0.0 | 1 | 1.8 | 0 | 0.0 | 0 | 0.0 | 1 | 0.4 | ||
Recruitment setting | Primary | 4 | 25.0 | 2 | 3.6 | 5 | 7.6 | 46 | 36.2 | 57 | 21.6 | |
Secondary only | 2 | 12.5 | 2 | 3.6 | 5 | 7.6 | 17 | 13.4 | 26 | 9.8 | ||
Tertiary only | 3 | 18.8 | 17 | 30.9 | 30 | 45.5 | 47 | 37.0 | 97 | 36.7 | ||
Secondary or tertiary (not specified) | 0 | 0.0 | 0 | 0.0 | 2 | 3.0 | 3 | 2.4 | 5 | 1.9 | ||
Community | 7 | 43.8 | 4 | 7.3 | 2 | 3.0 | 15 | 11.8 | 28a
| 10.6 | ||
Emergency | 1 | 6.3 | 5 | 9.1 | 0 | 0.0 | 7 | 5.5 | 13 | 4.9 | ||
Hospice | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | ||
Social care | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | ||
Other setting | 0 | 0.0 | 1 | 1.8 | 1 | 1.5 | 0 | 0.0 | 2b
| 0.8 | ||
Not clear | 0 | 0.0 | 32 | 58.2 | 22 | 33.3 | 9 | 7.1 | 63c
| 23.9 | ||
Trial design | Parallel | 13 | 81.3 | 48 | 87.3 | 59 | 89.4 | 103 | 81.1 | 233 | 88.3 | |
Sequential | 0 | 0.0 | 1 | 1.8 | 1 | 1.5 | 1 | 0.8 | 3 | 1.1 | ||
Crossover | 0 | 0.0 | 1 | 1.8 | 2 | 3.0 | 5 | 3.9 | 9 | 3.4 | ||
Cluster | 2 | 12.5 | 0 | 0.0 | 2 | 3.0 | 11 | 8.7 | 15 | 5.7 | ||
Factorial | 1 | 6.3 | 5 | 9.1 | 2 | 3.0 | 7 | 5.5 | 15 | 5.7 | ||
Number of trial arms | 2 | 12 | 75.0 | 42 | 76.4 | 46 | 69.7 | 85 | 66.9 | 185 | 70.1 | |
3 | 3 | 18.8 | 7 | 12.7 | 10 | 15.2 | 29 | 22.8 | 49 | 18.6 | ||
4 | 1 | 6.3 | 4 | 7.3 | 4 | 6.1 | 7 | 5.5 | 16 | 6.1 | ||
5 | 0 | 0.0 | 2 | 3.6 | 2 | 3.0 | 5 | 3.9 | 9 | 3.4 | ||
6 or more | 0 | 0.0 | 0 | 0.0 | 4 | 6.1 | 1 | 0.8 | 5d
| 1.9 | ||
Type of intervention e, f
| Pharmaceutical | 3 | 18.8 | 41 | 74.5 | 54 | 81.8 | 34 | 26.8 | 132 | 50.0 | |
Cellular and gene therapy | 0 | 0.0 | 1 | 1.8 | 2 | 3.0 | 0 | 0.0 | 3 | 1.1 | ||
Medical device | 0 | 0.0 | 5 | 9.1 | 5 | 7.6 | 16 | 12.6 | 26 | 9.8 | ||
Surgery | 0 | 0.0 | 3 | 5.5 | 1 | 1.5 | 10 | 7.9 | 14 | 5.3 | ||
Radiotherapy | 0 | 0.0 | 1 | 1.8 | 3 | 4.5 | 9 | 7.1 | 13 | 4.9 | ||
Psychological and behavioural | 6 | 37.5 | 0 | 0.0 | 1 | 1.5 | 22 | 17.3 | 29 | 11.0 | ||
Physical | 2 | 12.5 | 2 | 3.6 | 0 | 0.0 | 10 | 7.9 | 14 | 5.3 | ||
Complimentary | 0 | 0.0 | 0 | 0.0 | 1 | 1.5 | 5 | 3.9 | 6 | 2.3 | ||
Resources and infrastructure | 1 | 6.3 | 1 | 1.8 | 1 | 1.5 | 19 | 15.0 | 22 | 8.3 | ||
Other | 4 | 25.0 | 2 | 3.6 | 1 | 1.5 | 12 | 9.4 | 19 | 7.2 | ||
Number of primary outcomes | 1 | 11 | 68.8 | 47 | 85.5 | 51 | 77.3 | 101 | 79.5 | 210 | 79.5 | |
2 | 2 | 12.5 | 3 | 5.5 | 10 | 15.2 | 13 | 10.2 | 28 | 10.6 | ||
3 | 1 | 6.3 | 4 | 7.3 | 2 | 3.0 | 1 | 0.8 | 8 | 3.0 | ||
4 or more | 2 | 12.5 | 1 | 1.8 | 2 | 3.0 | 11 | 8.7 | 16 | 6.1 | ||
Primary outcome type | Subjective | 1 primary outcome | 3 | 18.8 | 0 | 0.0 | 2 | 3.0 | 39 | 30.7 | 44 | 16.7 |
2 + primary outcomes | 1 | 6.3 | 0 | 0.0 | 0 | 0.0 | 4 | 3.1 | 5 | 1.9 | ||
Objective | 1 primary outcome | 6 | 37.5 | 46 | 83.6 | 46 | 69.7 | 53 | 41.7 | 151 | 57.2 | |
2 + primary outcomes | 3 | 18.8 | 6 | 10.9 | 13 | 19.7 | 6 | 4.7 | 28 | 10.6 | ||
Both | 1 primary outcome | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 3 | 2.4 | 3g
| 1.1 | |
2 + primary outcomes | 1 | 6.3 | 2 | 3.6 | 1 | 1.5 | 14 | 11.0 | 18 | 6.8 | ||
Not clear | 1 primary outcome | 2 | 12.5 | 1 | 1.8 | 3 | 4.5 | 6 | 4.7 | 12 | 4.5 | |
2 + primary outcomes | 0 | 0.0 | 0 | 0.0 | 1 | 1.5 | 2 | 1.6 | 3 | 1.1 | ||
Allocation ratio | Equal e.g. 1:1 | 13 | 81.3 | 46 | 83.6 | 55 | 83.3 | 115 | 90.6 | 229 | 86.7 | |
Not equal e.g. 2:1 | 2 | 12.5 | 8 | 14.5 | 10 | 15.2 | 12 | 9.4 | 32 | 12.1 | ||
Not clear | 1 | 6.3 | 1 | 1.8 | 1 | 1.5 | 0 | 0.0 | 3 | 1.1 | ||
Unit of randomisation | Individual | 12 | 75.0 | 52 | 94.5 | 62 | 93.9 | 113 | 89.0 | 239 | 90.5 | |
GP practice | 0 | 0.0 | 0 | 0.0 | 1 | 1.5 | 9 | 7.1 | 10 | 3.8 | ||
Dyad (e.g. mother-child) | 1 | 6.3 | 1 | 1.8 | 1 | 1.5 | 2 | 1.6 | 5 | 1.9 | ||
Other | 3 | 18.8 | 2 | 3.6 | 2 | 3.0 | 3 | 2.4 | 10h
| 3.8 | ||
Blinding | Yes, blinding | 11 | 68.8 | 37 | 67.3 | 45 | 68.2 | 69 | 54.3 | 162 | 61.4 | |
No, not blinded | Justification provided | 2 | 12.5 | 3 | 5.5 | 5 | 7.6 | 33 | 26.0 | 43i
| 16.3 | |
Justification not provided | 1 | 6.3 | 9 | 16.4 | 15 | 22.7 | 10 | 7.9 | 35 | 13.3 | ||
Not clear | 2 | 12.5 | 6 | 10.9 | 1 | 1.5 | 15 | 11.8 | 24 | 9.1 |
Variations in published material
Material | Journal (N in cohort) | Total (N = 264) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
BMJ (N = 16) |
NEJM (N = 55) |
Lancet (N = 66) |
HTA (N = 127) | |||||||
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% | |
Main trial publication | 16 | 100.0 | 55 | 100.0 | 66 | 100.0 | 127 | 100.0 | 264 | 100.0 |
Study protocol as supplementary material | 0 | 0.0 | 50 | 90.9 | 0 | 0.0 | NA | - | 50 | 18.9 |
Other supplementary material excluding study protocol | 5 | 31.3 | 52 | 94.5 | 50 | 75.8 | NA | - | 107 | 40.5 |
Trial oversight committees
Committee(s) reported | Journal (N in cohort) | Total (N = 264) | |||
---|---|---|---|---|---|
BMJ (N = 16) |
NEJM (N = 55) |
Lancet (N = 66) |
HTA (N = 127) | ||
TSC and DMC reported | 4 25.0% | 31 56.4% | 19 28.8% | 55 43.3% | 109 41.3% |
N papers reporting TSC (N papers reporting DMC) | |||||
Acknowledged/listed | 2 (2) | 19 (23) | 14 (15) | 52 (50) | 87 (90) |
Main paper | 2 (2) | 7 (6) | 5 (4) | 3 (5) | 17 (17) |
Supplementary paper | 0 (0) | 0 (0) | 0 (0) | NA | 0 (0) |
Protocol | 0 (0) | 5 (2) | 0 (0) | NA | 5 (2) |
TSC only reported | 2 12.5% | 3 5.5% | 1 1.5% | 29 22.8% | 35 13.3% |
N papers reporting TSC | |||||
Acknowledged/listed | 1 | 2 | 1 | 19 | 23 |
Main paper | 1 | 1 | 0 | 10 | 12 |
Supplementary paper | 0 | 0 | 0 | NA | 0 |
Protocol | 0 | 0 | 0 | NA | 0 |
Reason for no DMC provided | 0 | 0 | 0 | 3 | 3 |
DMC only reported | 0 0.0% | 17 30.9% | 26 39.4 | 6 4.7% | 49 18.6% |
N papers reporting DMC | |||||
Acknowledged / listed | 0 | 8 | 3 | 5 | 16 |
Main paper | 0 | 6 | 22 | 1 | 29 |
Supplementary paper | 0 | 1 | 1 | NA | 2 |
Protocol | 0 | 2 | 0 | NA | 2 |
Reason for no TSC provided | 0 | 0 | 0 | 0 | 0 |
Neither committee reported | 10 62.5% | 4 7.3% | 20 30.3% | 37 29.1% | 71 26.9% |
N papers | |||||
Reason for no TSC provided | 0 | 0 | 0 | 0 | 0 |
Reason for no DMC provided | 0 | 2 | 0 | 0 | 2 |
‘A data monitoring committee for efficacy is not required for this study. Data safety monitoring will be conducted on an ongoing basis as detailed in the Safety Review Plan’. (NEJM44)
Intervention type | TSC reported | DMC reported | |||||||
---|---|---|---|---|---|---|---|---|---|
Yes | No | Yes | No | ||||||
N
|
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% | |
Pharmaceutical | 132 | 68 | 51.5% | 64 | 48.5% | 97 | 73.5% | 35 | 26.5% |
Cellular and gene therapy | 3 | 0 | 0.0% | 3 | 100.0% | 2 | 66.7% | 1 | 33.3% |
Medical device | 26 | 17 | 65.4% | 9 | 34.6% | 19 | 73.1% | 7 | 26.9% |
Surgery | 14 | 9 | 64.3% | 5 | 35.7% | 9 | 64.3% | 5 | 35.7% |
Radiotherapy | 13 | 7 | 53.8% | 6 | 46.2% | 5 | 38.5% | 8 | 61.5% |
Psychological and behavioural | 29 | 14 | 48.3% | 15 | 51.7% | 11 | 37.9% | 18 | 62.1% |
Physical | 14 | 11 | 78.6% | 3 | 21.4% | 8 | 57.1% | 6 | 42.9% |
Complimentary | 6 | 3 | 50.0% | 3 | 50.0% | 2 | 33.3% | 4 | 66.7% |
Resources and infrastructure | 22 | 13 | 59.1% | 9 | 40.9% | 5 | 22.7% | 17 | 77.3% |
Other | 19 | 13 | 68.4% | 6 | 31.6% | 7 | 36.8% | 12 | 63.2% |
Intervention type | Committee(s) reported | ||||||||
---|---|---|---|---|---|---|---|---|---|
TSC and DMC | TSC and no DMC | DMC and no TSC | No TSC and no DMC | ||||||
N
|
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% | |
Pharmaceutical | 132 | 60 | 45.5% | 8 | 6.1% | 37 | 28.0% | 27 | 20.5% |
Cellular and gene therapy | 3 | 0 | 0.0% | 0 | 0.0% | 2 | 66.7% | 1 | 33.3% |
Medical device | 26 | 16 | 61.5% | 1 | 3.8% | 3 | 11.5% | 6 | 23.1% |
Surgery | 14 | 6 | 42.9% | 3 | 21.4% | 3 | 21.4% | 2 | 14.3% |
Radiotherapy | 13 | 4 | 30.8% | 3 | 23.1% | 1 | 7.7% | 5 | 38.5% |
Psychological and behavioural | 29 | 9 | 31.0% | 5 | 17.2% | 2 | 6.9% | 13 | 44.8% |
Physical | 14 | 7 | 50.0% | 4 | 28.6% | 1 | 7.1% | 2 | 14.3% |
Complimentary | 6 | 2 | 33.3% | 1 | 16.7% | 0 | 0.0% | 3 | 50.0% |
Resources and infrastructure | 22 | 4 | 18.2% | 9 | 40.9% | 1 | 4.5% | 8 | 36.4% |
Other | 19 | 7 | 36.8% | 6 | 31.6% | 0 | 0.0% | 6 | 31.6% |
Trial steering committees
Name
Name of TSC | Journal (N reporting TSC) | Total (N = 144) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
BMJ (N = 6) |
NEJM (N = 34) |
Lancet (N = 20) |
HTA (N = 84) | |||||||
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% |
n
|
n/N% | |
Trial Steering Committee | 6 | 100.0 | 1 | 2.9 | 6 | 30.0 | 48 | 57.1 | 61 | 41.7 |
Steering Committee | 0 | 0.0 | 18 | 52.9 | 12 | 60.0 | 12 | 14.3 | 42 | 29.2 |
Steering Group | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 14 | 16.7 | 14 | 9.7 |
Executive Committee | 0 | 0.0 | 9 | 26.5 | 1 | 5.0 | 0 | 0.0 | 10 | 6.9 |
Trial Steering Group | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 4 | 4.9 | 4 | 2.8 |
Advisory Committee | 0 | 0.0 | 2 | 5.9 | 0 | 0.0 | 0 | 0.0 | 2 | 1.4 |
Project Steering Group | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 2 | 2.4 | 2 | 1.4 |
Study Steering Committee | 0 | 0.0 | 1 | 2.9 | 0 | 0.0 | 1 | 1.2 | 2 | 1.4 |
Clinical Research Organisation | 0 | 0.0 | 1 | 2.9 | 0 | 0.0 | 0 | 0.0 | 1 | 0.7 |
External Protocol Advisory Committee | 0 | 0.0 | 1 | 2.9 | 0 | 0.0 | 0 | 0.0 | 1 | 0.7 |
Monitoring and Steering Committee | 0 | 0.0 | 1 | 2.9 | 0 | 0.0 | 0 | 0.0 | 1 | 0.7 |
Neurology Steering Committee | 0 | 0.0 | 0 | 0.0 | 1 | 5.0 | 0 | 0.0 | 1 | 0.7 |
Scientific Advisory Group | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.2 | 1 | 0.7 |
Steering and Advisory Group | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.2 | 1 | 0.7 |
Trial Advisory Group | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 1.2 | 1 | 0.7 |
Membership
Journal (N reporting TSC) | Total (N = 144) | ||||||
---|---|---|---|---|---|---|---|
BMJ (N = 6) |
NEJM (N = 34) |
Lancet (N = 20) |
HTA (N = 84) | ||||
Number of members |
n (n/N%)
| 3 (50.0) | 20 (58.8) | 16 (80.0) | 71 (84.5) | 110 (76.4) | |
mean (SD)
| 5 (2) | 13 (12) | 8 (5) | 8 (6) | 9 (7) | ||
median (IQR)
| 5 (3) | 9 (9) | 6 (5) | 6 (5) | 7 (6) | ||
(min, max)
| (4, 7) | (4, 52) | (3, 22) | (2, 34) | (2, 52) | ||
Chair indicated |
n (n/N%)
| 3 (50.0) | 20 (58.8) | 9 (45.0) | 52 (61.9) | 84 (58.3) | |
Expertise of members indicated |
n (n/N %)
| 1 (16.7) | 10 (29.4) | 4 (20.0) | 51 (60.7) | 66 (45.8) | |
Expertise | Chief investigator |
n (n/N%)
| 0 (0.0) | 9 (26.5) | 2 (10.0) | 13 (15.5) | 24 (16.7) |
Trial coordinator |
n (n/N%)
| 0 (0.0) | 1 (2.9) | 0 (0.0) | 5 (6.0) | 6 (4.2) | |
Clinical expert |
n (n/N%)
| 0 (0.0) | 3 (8.8) | 2 (10.0) | 41 (48.8) | 46 (31.9) | |
Statistician |
n (n/N%)
| 0 (0.0) | 4 (11.8) | 2 (10.0) | 23 (27.4) | 29 (20.1) | |
PPI representative |
n (n/N%)
| 1 (16.7) | 2 (5.9) | 0 (0.0) | 36 (42.9) | 39 (27.1) | |
Health economist |
n (n/N%)
| 0 (0.0) | 0 (0.0) | 0 (0.0) | 11 (13.1) | 11 (7.6) | |
Sponsor representative |
n (n/N%)
| 0 (0.0) | 5 (14.7) | 1 (5.0) | 2 (2.4) | 8 (5.6) | |
Industry representative |
n (n/N%)
| 0 (0.0) | 1 (2.9) | 0 (0.0) | 1 (1.2) | 2 (1.4) |
Meetings
Role
‘The Steering Committee was responsible for overseeing the scientific and operational aspect of the study’. (Lancet49)
‘The (TSC) vouched for the completion and accuracy of the data gathering and analysis’. (Lancet6)
‘The (TSC) vouches for the accuracy and completeness of the data and the analysis and the fidelity of the study to the protocol’.
‘(the DMC) made recommendations to the Steering Committee regarding endpoint analysis or potential safety concerns’. (Lancet49)
‘The (TSC) ensured that the rights, safety and well-being of the trial participants were the most important considerations and prevailed over the interests of science and society’.
Activities
‘Before the start of recruitment and data collection, we changed the primary outcome to the reported quit attempt measure, which is predictive of eventual cessation. This followed expert advice from the Trial Steering Committee on the basis of smoking cessation research and approval from the Data Monitoring Committee’. (BMJ15)
‘Without revealing any results, the DSMB recommended to the Executive Committee and sponsor that the trial continue to the original pre-planned sample size. The basis for this recommendation was that, because of the rapid enrolment at the time of the interim analysis, there was insufficient 90-day data to assess the secondary endpoints, although there were no safety concerns. The Executive Committee and sponsor accepted the DSMB recommendation to continue enrolment, but remained masked to all study results’. (Lancet36)
‘The independent Data and Safety Monitoring Committee and Study Steering Committee concluded that both progression-free survival and overall survival were significantly longer in the trametinib group than in the chemotherapy group and that immediate crossover to trametinib should be permitted’. (NEJM23)
‘In a meeting of the Trial Steering Committee, it was accepted that it would not be viable to proceed with the trial and the formal procedure for closure (including notification of MHRA and MREC) was initiated in May 2005’. (HTA75)
‘Although the DMC recommended continuation of recruitment into FOOD following their meeting in 2002, the Steering Committee took the decision to stop recruitment on 31 July 2003’. (HTA88)
‘The project Steering Group determined that (a prescription) was inappropriate to a pragmatic study of this kind. It was agreed that the outcome would be more likely to represent the likely outcome of introducing TUVP if staff were to manage patients according to existing norms’. (HTA30)
‘On reflection and discussion of these issues, the research team and the Trial Steering Committee members felt that some of these issues could have been addressed (…). They concluded that many of the problems encountered were a direct consequence of the changes in research governance and ethical procedures that prevent members of the research team approaching patients directly, but instead place the burden of recruiting patients on busy primary care professionals’. (HTA75)
‘Finally, at the request of the TSC, a further exploratory analysis to examine the interactive effect of age on the effectiveness of MRI compared with no MRI was conducted’. (HTA111)
‘The identification of treatments was established by code break in the presence of the Chief Investigator, Trial Statistician and Trial Coordinator on 20 March 2007 by agreement with the TSC and DMEC’. (HTA104)