A study published in The Spine Journal examines where spine-related studies registered on www.ClinicalTrials.gov end up and publication rate for completed trials.
The researchers searched on the ClinicalTrials.gov website several times to find studies related to herniated disc, degenerative disc disease, stenosis and spondylolisthesis in addition to other conditions. There were 263 spine-related studies identified during the search. Here are eight findings on the clinical trials:
1. The status of the trials was:
• 72 completed
• 70 inactive — not recruiting
• 74 recruiting
• 11 recruiting by invitation
• 13 not yet recruiting
• 18 terminated
• Four withdrawn
• One suspended
2. Among the completed studies, 38.9 percent were published. The average publication time was 27.9 months from the completion date. Comparatively, 22.8 percent of arthroplasty trials were published and 43.2 percent of orthopedic trauma trials were published.
3. The average length of time from study completion to manuscript preparation for the unpublished studies was 62 months.
4. There wasn't any difference in publication likelihood based on where the study was conducted or whether the study was registered before or after initiation.
5. The relationship between the publication rate and funding type was statistically significant.
6. The type of research had a statistically significant relationship with the industry-funded studies, and those evaluating devices had a lower publication rate.
7. Studies funded by a federal agency and studies comparing surgery to nonoperative care had the highest publication rates.
8. When studies are posted before initiation, they can increase transparency and the accessibility for evaluation.
"In addition to ClinicalTrials.gov website fulfilling its original goal of providing patients information about clinical studies, it can also provide a means of tracking publication of prospective studies, changes to protocols, matching publication content to posted study design, etc., and raise queries concerning the reason for not publishing what appear to be well-designed studies," concluded the study authors.
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