Trial Reporting in ClinicalTrials.gov — The Final Rule
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B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)). ''(2) TYPES OF FEES.-Of the total revenue amount determined for a fiscal year under paragraph (1)-''(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements); ''(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and ''(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products). ''(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL YEAR 2007.-For purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2007 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of commercial investigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12month period for which data on such submissions is available.
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Beyond journal publication, trial registries and preprint servers are important venues for dissemination.
“Beyond journal publication, trial registries and preprint servers are important venues for dissemination.121 122 123”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [121]
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Supervised Learning for the Prediction of Firm Dynamics
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Borysowski, J., Wnukiewicz‐Kozłowska, A., & Górski, A. (2020) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.14223 · Cited by 26 · see citing works
Gupta, S., Silveira, D. A., Piedade, G. P. S., Ostrowski, M. P., Mombach, J. C. M., & Hashimoto, R. F. (2023) · Non-coding RNA Research · doi:10.1016/j.ncrna.2023.10.008 · Cited by 25 · see citing works
McElfish, P. A., Long, C. R., Selig, J. P., Rowland, B., Purvis, R. S., James, L. P., Holland, A., Felix, H. C., & Narcisse, M. (2018) · Clinical and Translational Science · doi:10.1111/cts.12561 · Cited by 24 · see citing works
Sharing individual participant data: through a systematic reviewer lens
Rydzewska, L. H. M., Stewart, L. A., & Tierney, J. F. (2022) · Trials · doi:10.1186/s13063-021-05787-4 · Cited by 24 · see citing works
Knowledge bases and software support for variant interpretation in precision oncology
Borchert, F., Möck, A., Tomczak, A., Hügel, J., Alkarkoukly, S., Knurr, A., Volckmar, A., Stenzinger, A., Schirmacher, P., Debus, J., et al. (2021) · Briefings in Bioinformatics · doi:10.1093/bib/bbab134 · Cited by 24 · see citing works
DeVito, N., Bacon, S., & Goldacre, B. M. (2018) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/266452 · Cited by 23 · see citing works
Lee, K., Wei, C.-H., & Lu, Z. (2020) · Briefings in Bioinformatics · doi:10.1093/bib/bbaa142 · Cited by 23 · see citing works
Long, J., Liang, R., Zheng, Q., Yuan, G., Xin, Z., Chen, X., Lai, F., & Liu, Y. (2021) · Diabetes Metabolic Syndrome and Obesity · doi:10.2147/dmso.s288065 · Cited by 22 · see citing works
Sobczyk, M., Zheng, J., Smith, G. D., & Gaunt, T. R. (2023) · BMJ Open · doi:10.1136/bmjopen-2023-072087 · Cited by 24 · see citing works
Publication and Dissemination of Results in Clinical Trials of Neurology
Sreekrishnan, A., Mampre, D. M., Ormseth, C. H., Miyares, L. C., Leasure, A. C., Ross, J. S., & Sheth, K. N. (2018) · JAMA Neurology · doi:10.1001/jamaneurol.2018.0674 · Cited by 23 · see citing works
Welsch, C. A., Rust, W. L., & CSETE, M. E. (2018) · Stem Cells Translational Medicine · doi:10.1002/sctm.18-0156 · Cited by 22 · see citing works
Connecting the public with clinical trial options: The ResearchMatch Trials Today tool
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Publication of Results of Registered Trials With Published Study Protocols, 2011-2022
Vorland, C. J., Brown, A. W., Halil Kilicoglu, B., Ying, X., & Mayo‐Wilson, E. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.50688 · Cited by 20 · see citing works
Caveat emptor: the combined effects of multiplicity and selective reporting
Li, T., Mayo‐Wilson, E., Fusco, N., Hong, H., & Dickersin, K. (2018) · Trials · doi:10.1186/s13063-018-2888-9 · Cited by 21 · see citing works
Co-opting of ClinicalTrials.gov by patient-funded studies
Wagner, D. E., Turner, L. G., Panoskaltsis‐Mortari, A., Weiss, D. J., & Ikonomou, L. (2018) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(18)30242-x · Cited by 20 · see citing works
Industrializing AI-powered drug discovery: lessons learned from the Patrimony computing platform
Guedj, M., Swindle, J., Hamon, A., Hubert, S., Desvaux, E., Laplume, J., Xuereb, L., Lefèbvre, C., Haudry, Y., Gabarroca, C., et al. (2022) · Expert Opinion on Drug Discovery · doi:10.1080/17460441.2022.2095368 · Cited by 23 · see citing works
Focus on sharing individual patient data distracts from other ways of improving trial transparency
Hoffmann, T., Glasziou, P., Beller, E., Goldacre, B. M., & Chalmers, I. (2017) · BMJ · doi:10.1136/bmj.j2782 · Cited by 20 · see citing works
- Authors
- Zarin, D. A., Tse, T., Williams, R. J., & Carr, S.
- Affiliations
- National Institutes of Health (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-11-17
- Volume
- 375
- Issue
- 20
- Pages
- 1998-2004
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5225905
- OpenAlex
- W2520965749
- Cited by
- 332
- References
- 11
- Citations by year
- 2026: 37 · 2025: 21 · 2024: 20 · 2023: 21 · 2022: 20 · 2021: 34 · 2020: 43 · 2019: 34 · 2018: 46 · 2017: 51 · 2016: 4
- FWCI
- 56.25
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- public-domain
- Locations
- New England Journal of Medicine (publishedVersion, public-domain)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (Z99 LM999999)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Keywords
- ClinicalTrials.gov, clinical trial registration, final rule, clinical trial reporting, regulatory fees, Investigational New Drug application
- MeSH terms
- Clinical Trials as Topic, Registries, United States, United States Dept. of Health and Human Services, United States Food and Drug Administration, Databases, Factual, Government Regulation, Mandatory Programs
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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