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Failure of investigational drugs in late-stage clinical development and publication of trial results
Importance Many investigational drugs fail in late-stage clinical development. A better
understanding of why investigational drugs fail can inform clinical practice, regulatory …
understanding of why investigational drugs fail can inform clinical practice, regulatory …
Risks of phase I research with healthy participants: a systematic review
Background/aims: Tragedies suggest that phase I trials in healthy participants may be highly
risky. This possibility raises concern that phase I trials may exploit healthy participants to …
risky. This possibility raises concern that phase I trials may exploit healthy participants to …
A systematic review of the processes used to link clinical trial registrations to their published results
Background Studies measuring the completeness and consistency of trial registration and
reporting rely on linking registries with bibliographic databases. In this systematic review, we …
reporting rely on linking registries with bibliographic databases. In this systematic review, we …
Clinical trial design and dissemination: comprehensive analysis of clinicaltrials. gov and PubMed data since 2005
Objective To investigate the distribution, design characteristics, and dissemination of clinical
trials by funding organisation and medical specialty. Design Cross sectional descriptive …
trials by funding organisation and medical specialty. Design Cross sectional descriptive …
[HTML][HTML] Responsible translation of stem cell research: an assessment of clinical trial registration and publications
We assessed the extent to which the publication of clinical trial results of innovative cell-
based interventions reflects International Society for Stem Cell Research best practice …
based interventions reflects International Society for Stem Cell Research best practice …
Clinical development of new drugs for adults and children with cancer, 2010-2020
A Arfè, C Narang, SG DuBois, G Reaman… - JNCI: Journal of the …, 2023 - academic.oup.com
Background Many new molecular entities enter clinical development to evaluate potential
therapeutic benefits for oncology patients. We characterized adult and pediatric …
therapeutic benefits for oncology patients. We characterized adult and pediatric …
Temporal trends and factors associated with cardiovascular drug development, 1990 to 2012
Cardiovascular disease remains a leading cause of death, but stakeholders have recently
raised concerns about the pace of innovation and investment in develo** new …
raised concerns about the pace of innovation and investment in develo** new …
Inefficiencies and patient burdens in the development of the targeted cancer drug sorafenib: a systematic review
J Mattina, B Carlisle, Y Hachem, D Fergusson… - PLoS …, 2017 - journals.plos.org
Failure in cancer drug development exacts heavy burdens on patients and research
systems. To investigate inefficiencies and burdens in targeted drug development in cancer …
systems. To investigate inefficiencies and burdens in targeted drug development in cancer …
Why clinical translation cannot succeed without failure
The high rates of attrition that occur in drug development are widely regarded as
problematic, but the failure of well-designed studies benefits both researchers and …
problematic, but the failure of well-designed studies benefits both researchers and …
What is human research for? reflections on the omission of scientific integrity from the belmont report
J Kimmelman - Perspectives in Biology and Medicine, 2020 - muse.jhu.edu
The Belmont Report has provided a useful and virtually universal framework for protecting
human subjects from research abuses. However, it provides little to no guidance on the …
human subjects from research abuses. However, it provides little to no guidance on the …