Failure of investigational drugs in late-stage clinical development and publication of trial results

TJ Hwang, D Carpenter, JC Lauffenburger… - JAMA internal …, 2016 - jamanetwork.com
Importance Many investigational drugs fail in late-stage clinical development. A better
understanding of why investigational drugs fail can inform clinical practice, regulatory …

Risks of phase I research with healthy participants: a systematic review

RA Johnson, A Rid, E Emanuel, D Wendler - Clinical Trials, 2016 - journals.sagepub.com
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 …

A systematic review of the processes used to link clinical trial registrations to their published results

R Bashir, FT Bourgeois, AG Dunn - Systematic reviews, 2017 - Springer
Background Studies measuring the completeness and consistency of trial registration and
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

M Zwierzyna, M Davies, AD Hingorani, J Hunter - Bmj, 2018 - bmj.com
Objective To investigate the distribution, design characteristics, and dissemination of clinical
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

M Fung, Y Yuan, H Atkins, Q Shi, T Bubela - Stem Cell Reports, 2017 - cell.com
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 …

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 …

Temporal trends and factors associated with cardiovascular drug development, 1990 to 2012

TJ Hwang, JC Lauffenburger, JM Franklin… - JACC: Basic to …, 2016 - jacc.org
Cardiovascular disease remains a leading cause of death, but stakeholders have recently
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 …

Why clinical translation cannot succeed without failure

AJ London, J Kimmelman - Elife, 2015 - elifesciences.org
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 …

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 …