Primary outcome switching among drug trials with and without principal investigator financial ties to industry: a cross-sectional study. Jones, C. W., Misemer, B. S., Platts-Mills, T. F., Ahn, R., Woodbridge, A., Abraham, A., Saba, S., Korenstein, D., Madden, E., & Keyhani, S. BMJ Open, 8(2):e019831, February, 2018.
Primary outcome switching among drug trials with and without principal investigator financial ties to industry: a cross-sectional study [link]Paper  doi  abstract   bibtex   
Objectives To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes. Design Cross-sectional study. Setting Human subjects drug trials published in ‘core clinical’ MEDLINE journals in 2013. Primary and secondary outcome measures The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials. Results Of 192 included trials, 134 (70%) were positive and 58 (30%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68%), of which 78% were positive, versus 53% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78%vs48%, P\textless0.001) and were more likely to have prospectively registered a clearly defined primary outcome(62%vs35%, P\textless0.001). Conclusions Less than half of the trials in this cohort were prospectively registered with a clear primary outcome that was consistent with the primary outcome reported in the published manuscript. The presence of investigator financial ties was associated with higher quality registration practices, though this association diminished after adjusting for factors that impact registration quality.
@article{jones_primary_2018,
	title = {Primary outcome switching among drug trials with and without principal investigator financial ties to industry: a cross-sectional study},
	volume = {8},
	copyright = {© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/},
	issn = {2044-6055, 2044-6055},
	shorttitle = {Primary outcome switching among drug trials with and without principal investigator financial ties to industry},
	url = {https://bmjopen.bmj.com/content/8/2/e019831},
	doi = {10.1136/bmjopen-2017-019831},
	abstract = {Objectives To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes.
Design Cross-sectional study.
Setting Human subjects drug trials published in ‘core clinical’ MEDLINE journals in 2013.
Primary and secondary outcome measures The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials.
Results Of 192 included trials, 134 (70\%) were positive and 58 (30\%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68\%), of which 78\% were positive, versus 53\% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40\%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95\% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78\%vs48\%, P{\textless}0.001) and were more likely to have prospectively registered a clearly defined primary outcome(62\%vs35\%, P{\textless}0.001).
Conclusions Less than half of the trials in this cohort were prospectively registered with a clear primary outcome that was consistent with the primary outcome reported in the published manuscript. The presence of investigator financial ties was associated with higher quality registration practices, though this association diminished after adjusting for factors that impact registration quality.},
	language = {en},
	number = {2},
	urldate = {2019-05-14},
	journal = {BMJ Open},
	author = {Jones, Christopher W. and Misemer, Benjamin S. and Platts-Mills, Timothy F. and Ahn, Rosa and Woodbridge, Alexandra and Abraham, Ann and Saba, Susan and Korenstein, Deborah and Madden, Erin and Keyhani, Salomeh},
	month = feb,
	year = {2018},
	pmid = {29439079},
	keywords = {7 Ignorance and funding bias, Biais de financement, clinicaltrials.gov, conflict of interest, trial registration},
	pages = {e019831},
}

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