Accepted Manuscript The Fate of Prospective Spine Studies Registered on www.ClinicalTrials.gov Donna D. Ohnmeiss, Dr.Med. PII:
S1529-9430(14)01566-6
DOI:
10.1016/j.spinee.2014.10.008
Reference:
SPINEE 56059
To appear in:
The Spine Journal
Received Date: 11 October 2013 Revised Date:
12 August 2014
Accepted Date: 7 October 2014
Please cite this article as: Ohnmeiss DD, The Fate of Prospective Spine Studies Registered on www.ClinicalTrials.gov, The Spine Journal (2014), doi: 10.1016/j.spinee.2014.10.008. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
RI PT
ACCEPTED MANUSCRIPT
The Fate of Prospective Spine Studies Posted on www.ClinicalTrials.gov
SC
Donna D. Ohnmeiss, Dr.Med.
M AN U
Texas Back Institute Research Foundation
EP
TE D
Plano, Texas
AC C
Corresponding address: Donna D. Ohnmeiss, Dr.Med. Texas Back Institute Research Foundation 6020 W. Parker Rd., #200 Plano, TX 75093 Phone: 972-608-5097 Fax: 972-608-5137 e-mail: [email protected]
ACCEPTED MANUSCRIPT
RI PT
Fate of Registered Spine Trials
The Fate of Prospective Spine Studies
AC C
EP
TE D
M AN U
SC
Registered on www.ClinicalTrials.gov
1
ACCEPTED MANUSCRIPT Fate of Registered Spine Trials Abstract Background Context: There has been concern expressed about research ethics with respect to not fully
2
reporting data collected during clinical studies. One site available for all clinical trials is
3
ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the
4
treatment of their particular condition. The internationally available site offers general information about
5
the study, sponsor name, principal investigator, patients selection criteria, enrollment goal, study design,
6
outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent
7
data. The site can be used to identify studies conducted for a particular condition or intervention.
8
Purpose: The purpose of this study was to investigate the fate of spine-related studies registered on
9
www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials.
M AN U
SC
RI PT
1
Study Design/Setting: Analysis and classification of clinical studies posted on an international research
11
registry web page and literature search for related publications.
12
Patient Sample: NA.
13
Measures: The primary outcome measure was publication of the study registered on ClinicalTrials.gov.
14
Methods: Multiple searches were conducted on ClinicalTrials.gov website to identify studies related to
15
commonly treated spinal conditions including herniated disc, degenerative disc disease, stenosis, and
16
spondylolisthesis. Studies related to tumors, fractures, or that included non-spine conditions were not
17
included. For studies classified as completed more than 18 months prior to this review, literature searches
18
were conducted to determine if the results of the study had been published and factors related to
19
publication. The author has no financial conflict related to this work.
20
Results: There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site.
21
Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally
22
indicates collecting follow-up data), 74 recruiting, 11 recruiting by invitation, 13 not yet recruiting, 18
AC C
EP
TE D
10
2
ACCEPTED MANUSCRIPT Fate of Registered Spine Trials terminated, 4 withdrawn, and 1 suspended. Among the 72 studies indicated to be completed, 28 (38.9%)
2
have been published. The mean time to publish was 27.9 months from the date of completion. Among
3
unpublished studies, the mean length of time from study completion to the preparation of this manuscript
4
was 62.0 months. There was no difference in likelihood of publication based on the geographic region of
5
study origin or whether the study was registered before or after initiation. There were statistically
6
significant relationships between the publication rate and the funding type as well as the research type
7
(p
S1529-9430(14)01566-6
DOI:
10.1016/j.spinee.2014.10.008
Reference:
SPINEE 56059
To appear in:
The Spine Journal
Received Date: 11 October 2013 Revised Date:
12 August 2014
Accepted Date: 7 October 2014
Please cite this article as: Ohnmeiss DD, The Fate of Prospective Spine Studies Registered on www.ClinicalTrials.gov, The Spine Journal (2014), doi: 10.1016/j.spinee.2014.10.008. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
RI PT
ACCEPTED MANUSCRIPT
The Fate of Prospective Spine Studies Posted on www.ClinicalTrials.gov
SC
Donna D. Ohnmeiss, Dr.Med.
M AN U
Texas Back Institute Research Foundation
EP
TE D
Plano, Texas
AC C
Corresponding address: Donna D. Ohnmeiss, Dr.Med. Texas Back Institute Research Foundation 6020 W. Parker Rd., #200 Plano, TX 75093 Phone: 972-608-5097 Fax: 972-608-5137 e-mail: [email protected]
ACCEPTED MANUSCRIPT
RI PT
Fate of Registered Spine Trials
The Fate of Prospective Spine Studies
AC C
EP
TE D
M AN U
SC
Registered on www.ClinicalTrials.gov
1
ACCEPTED MANUSCRIPT Fate of Registered Spine Trials Abstract Background Context: There has been concern expressed about research ethics with respect to not fully
2
reporting data collected during clinical studies. One site available for all clinical trials is
3
ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the
4
treatment of their particular condition. The internationally available site offers general information about
5
the study, sponsor name, principal investigator, patients selection criteria, enrollment goal, study design,
6
outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent
7
data. The site can be used to identify studies conducted for a particular condition or intervention.
8
Purpose: The purpose of this study was to investigate the fate of spine-related studies registered on
9
www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials.
M AN U
SC
RI PT
1
Study Design/Setting: Analysis and classification of clinical studies posted on an international research
11
registry web page and literature search for related publications.
12
Patient Sample: NA.
13
Measures: The primary outcome measure was publication of the study registered on ClinicalTrials.gov.
14
Methods: Multiple searches were conducted on ClinicalTrials.gov website to identify studies related to
15
commonly treated spinal conditions including herniated disc, degenerative disc disease, stenosis, and
16
spondylolisthesis. Studies related to tumors, fractures, or that included non-spine conditions were not
17
included. For studies classified as completed more than 18 months prior to this review, literature searches
18
were conducted to determine if the results of the study had been published and factors related to
19
publication. The author has no financial conflict related to this work.
20
Results: There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site.
21
Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally
22
indicates collecting follow-up data), 74 recruiting, 11 recruiting by invitation, 13 not yet recruiting, 18
AC C
EP
TE D
10
2
ACCEPTED MANUSCRIPT Fate of Registered Spine Trials terminated, 4 withdrawn, and 1 suspended. Among the 72 studies indicated to be completed, 28 (38.9%)
2
have been published. The mean time to publish was 27.9 months from the date of completion. Among
3
unpublished studies, the mean length of time from study completion to the preparation of this manuscript
4
was 62.0 months. There was no difference in likelihood of publication based on the geographic region of
5
study origin or whether the study was registered before or after initiation. There were statistically
6
significant relationships between the publication rate and the funding type as well as the research type
7
(p
