Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?
Sign Up to like & getrecommendations! Published in 2020 at "European Journal of Pediatrics"
DOI: 10.1007/s00431-020-03715-3
Abstract: Investigator-initiated clinical trials are crucial for improving quality of care for children and pregnant women as they are often excluded from industry-initiated trials. However, trials have become increasingly time-consuming and costly since the EU Clinical… read more here.
Keywords: low risk; clinical trial; investigator initiated; regulation ... See more keywords
Improving the efficiency of clinical trials by standardizing processes for Investigator Initiated Trials
Sign Up to like & getrecommendations! Published in 2020 at "Contemporary Clinical Trials Communications"
DOI: 10.1016/j.conctc.2020.100579
Abstract: 1. Abstract Early phase clinical trials are the first step in testing new medications and therapeutics developed by clinical and biomedical investigators. These trials aim to find a safe dose of a newly targeted drug… read more here.
Keywords: improving efficiency; initiated trials; investigator initiated; clinical trials ... See more keywords
Quality evaluation of investigator‐initiated trials using post‐approval cancer drugs in Japan
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DOI: 10.1111/cas.13223
Abstract: Investigator‐initiated trials (IIT) are important aspects of medical research and have contributed substantially to modern oncology. IIT using post‐approval drugs have been conducted by domestic institutions in Japan. Data from the present study were obtained… read more here.
Keywords: phase; initiated trials; using post; investigator initiated ... See more keywords
First dose‐ranging study of remimazolam in Japanese patients undergoing gastrointestinal endoscopy: Phase II investigator‐initiated clinical trial
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DOI: 10.1111/den.14365
Abstract: Remimazolam, an ultra‐short‐acting benzodiazepine, has been used for procedural sedation in the United States. We conducted an investigator‐initiated clinical trial to determine the appropriate dose of remimazolam required for sedation during gastrointestinal endoscopy in Japanese… read more here.
Keywords: endoscopy; gastrointestinal endoscopy; investigator initiated; clinical trial ... See more keywords
Investigational medicinal products, related costs and hospital pharmacy services for investigator-initiated trials: A mixed-methods study
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DOI: 10.1371/journal.pone.0264427
Abstract: Background Conducting high quality investigator-initiated trials (IITs) is challenging and costly. The costs of investigational medicinal products (IMPs) in IITs and the role of hospital pharmacies in the planning of IITs are unclear. We conducted… read more here.
Keywords: hospital pharmacy; initiated trials; investigator initiated; imp ... See more keywords