Safety Evaluation in Clinical Trials

Author(s):  
Amy H. Xia ◽  
Brenda J. Crowe ◽  
Jesse A. Berlin
2011 ◽  
Vol 21 (2) ◽  
pp. 294-310 ◽  
Author(s):  
Xiaoming Li ◽  
William W. B. Wang ◽  
Guanghan F. Liu ◽  
Ivan S. F. Chan

2014 ◽  
Vol 5 (1) ◽  
pp. 45-60 ◽  
Author(s):  
M. van den Nieuwboer ◽  
E. Claassen ◽  
L. Morelli ◽  
F. Guarner ◽  
R.J. Brummer

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in ‘food’ studies.


2020 ◽  
Vol 10 (1) ◽  
pp. 1877-1888

The world of medicine explored the use of nanoparticles in therapeutics in the last two decades. Owing to the advantages nanoparticles offer, they are proving beneficial to overcome many drawbacks faced by small drug molecules. Since the nature, architecture, shape, size, and mechanism of action of nanomedicines totally different from regularly used drugs, it is important to work on the possible toxicity these nanoparticles are causing so that its safety can be ensured. In today’s scenario, a lot of industries and institutes are synthesizing nano drugs, so it is important to check its toxicity and safety evaluation under in vivo and in vitro conditions, as it has come to fore that number of metal and carbon-based nanoparticles, although proving useful further display increased toxicity. Taken into consideration nanoparticle toxicity and safety, the present review discusses the exact working of nanoparticles at the molecular, cellular, and physiological levels and the toxicity associated with it. The present strategies for safety assessment have also been reviewed. The research involving nanomaterials in therapeutics demand strict regulation in nanoparticle synthesis, its usage, properly regulated clinical trials ensuring safety assessment.


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