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Table 4 Comparison of selected protocol information registered and published for 12 trials on genome editing

From: Inadequate reporting quality of registered genome editing trials: an observational study

Protocol in registry vs. publicationsa No. (%) of trials
Sample size
 Equal absolute number in both sources 4 (33.3)
 Smaller sample size in publication 8 (66.7)
  Published full-textb 5 (41.7)
  Published abstract 3 (25.0)
Eligibility age
 Congruent in both sourcesc 7 (58.3)
 Reported different inclusion age ranged 5 (41.7)
  Published full-text 4 (33.3)
  Published abstract 1 (8.3)
Eligibility sex
 Congruent in both sourcese 8 (66.7)
 Sex not reported in publication 4 (33.3)
  Published full-text 2 (16.7)
  Published abstract 2 (16.7)
Other inclusion criteria
 Congruent in both sourcesf 3 (25.0)
 More informative in registrye 3 (25.0)
 More informative in article, with changed particular criteriag 1 (8.3)
 Only diagnosis defined with different levels of details 2 (16.7)
 Inclusion criteria not specifically stated in publicationh 3 (25.0)
Exclusion criteria
 Congruent in both sourcesf 1 (8.3)
 More informative in registryi 4 (33.3)
 More informative in publication 1 (8.3)
 Exclusion criteria not specifically stated in publicatione 6 (50.0)
Primary outcome measures (POMs)
 Congruent in both sourcesj 9 (75.0)
 New outcome introduced in publicationk 1 (8.3)
 POMs not reported clearly and separately from SOMs in article, but all registered POMs congruent to published 2 (16.7)
Secondary outcome measures (SOMs)
 Congruent in both sources 2 (16.7)
 More informative in registry 1 (8.3)
 New outcomes introduced in article 2 (16.7)
 Particular outcomes missing in progress report abstract 2 (16.7)
 One registered SOM published as POM 1 (8.3)
 POMs not reported clearly and separately from SOMs in article, but particular registered SOMs omitted in publication 2 (16.7)
 SOMs not registered in ClinicalTrials.gove 2 (16.7)
  1. aA total of 12 trials was published: 9 as a full-text and 3 as an abstract of the progress report
  2. bNCT03164135: registered vs. published 5 vs. 1; NCT02808442: 13 vs. 7; NCT03655678 and NCT03745287: 45 vs. 1 (reported preliminary results; the first patient included); NCT02746952: 25 vs. 14
  3. cTwo trials were published in a form of an abstract
  4. dNCT03525782: registered 18–70 years, published 36–84; NCT02808442: registered up to 17 years, published 6 months-18 years; NCT03655678 and NCT03745287: registered 12–35, published 18–35; NCT02746952: registered 16–69, published 16–70
  5. eOne trial was published in a form of an abstract
  6. fOne abstract was included, with a statement: “Patients were recruited according to the criteria in NCT03525782”
  7. gAlong with different levels of details, one trial also modified a particular inclusion criterion in the article (NCT02793856): stage IV non-small cell lung cancer and expected life span ≥ 6 months in the registry vs. stage IIIB or IV NSCLC and a life expectancy of over 3 months in the publication
  8. hOne trial was published as an abstract (NCT02702115), and two other reported a clinical summary of each included patient in the article, including the time of the first diagnosis of target disease, used therapy, intervention protocol, and safety outcomes (NCT03164135 and NCT03399448)
  9. iOne trial had “prior anti-CD19 cell therapy” as an exclusion criterion in, whilst in the published abstract, this treatment was allowed (NCT03939026)
  10. jThree trials were published in a form of an abstract
  11. kSafety was registered POM, whilst in the article safety along with feasibility were noted (NCT02793856). Feasibility was defined “by sufficient and viable edited T cells being able to be manufactured from the majority of enrolled patients”