How does financial sponsorship impact spine device clinical trials? Can we trust multicenter prospective randomized clinical trials to present the best evidence?
A study published in The Spine Journal examined how clinical trials report safety and effectiveness, and whether industry sponsorship leads to bias. The researchers examined clinical trials on ClinicalTrials.gov and compared the relationship between trial design and study sponsorship.
The researchers did not receive support for this work.
There were 1,638 studies found on the website including the word "spine" with 367 trials focusing on spine surgery. Another 200 — 54 percent — specifically studied spine surgery devices while the others focused on other issues related to spine surgery.
Here are five quick findings from the study:
1. The device trials were far more likely to have industry sponsorship than the non-device trials. Around 74 percent of the device trials had industry sponsorship, compared to 22.2 percent of non-device trials.
2. The industry-sponsored trials were also more likely to be multicenter — 80 percent of the industry sponsored trials took place at more than one site. Comparatively, only 29 percent of the non-industry sponsored trials were multicenter.
3. There were around four times as many participating study centers for the industry-sponsored trials and the sample sizes were larger.
4. In the United States, there were very few multicenter randomized trials that weren't sponsored by industry.
5. The authors concluded "previously published studies showing larger effect sizes in industry-sponsored vs. non-industry sponsored studies may be biased as a result of failure to take into account marked differences in design and purpose."