title: Spine device clinical trials: design and sponsorship.
abstract: BACKGROUND
  Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias.
  
  
  OBJECTIVE
  To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design.
  
  
  METHODS
  Analysis of data from a publicly available clinical trials database.
  
  
  METHODS
  Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models.
  
  
  RESULTS
  One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry.
  
  
  CONCLUSIONS
  Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose.
authors: Department of Clinical Affairs, SI-BONE, Inc., 3055 Olin Ave., Suite 220, San Jose, CA 95128, USA. Electronic address: dcher@si-bone.com.
authors: Daniel J
authors: DJ
authors: Cher
authors: Department of Clinical Affairs, SI-BONE, Inc., 3055 Olin Ave., Suite 220, San Jose, CA 95128, USA.
authors: Robyn A
authors: RA
authors: Capobianco
mesh_terms: D004864:Equipment and Supplies / Q000009:adverse effects* / Q000191:economics; D006801:Humans; D007221:Industry / Q000191:economics; D015337:Multicenter Studies as Topic / Q000191:economics / Q000379:methods; D019635:Neurosurgical Procedures / Q000295:instrumentation*; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000379:methods; D013131:Spine / Q000601:surgery*
keywords: Bias; Implants; Industry sponsorship; Medical devices; Multicenter clinical trials; Spine surgery