![]() The in vitro drugs release in water was followed by UV-Vis spectroscopy, and their antibacterial activity against Pseudomonas aeruginosa was evaluated for 11 days using the microdilution method.Īll the extracts demonstrated an inhibitory effect on the growth of the strain during the whole trial period. Poly(methyl methacrylate) cements loaded with 10 wt.% of Oleozon®, mixtures of Ciprofloxacin/Meropenem and Ciprofloxacin/Meropenem/Oleozon® were prepared. In this work, bone cements loaded with drugs with different mechanism of action were evaluated to determine its antibacterial effectiveness on Pseudomonas aeruginosa. However, the high prevalence of resistant germs and polymicrobial infections makes it necessary to search for new formulations of bone cements containing antibiotics for local antibacterial therapy. The FDA is committed to working with sponsors to discuss how decentralized elements may fit into a clinical trial.Antibiotic-loaded bone cements of poly(methyl methacrylate) are considered as very useful biomaterials for the management of corporal deep osseous infections. The FDA expects that clinical trials with decentralized elements will play an important role in addressing public health needs. safety monitoring of trial participants in a DCT.packaging and shipping of investigational products in a DCT and.determination of the appropriateness of investigational products for use in a DCT.obtaining informed consent (IC) and institutional review board oversight of the IC process in a DCT.roles and responsibilities of the sponsor and investigators in a DCT.use of digital health technologies to remotely acquire data in a DCT.conduct of remote clinical trial visits and clinical trial-related activities in a DCT.While the FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials, the new draft guidance covers recommendations on topics such as: “As we seek to improve our evidence generation system, decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.” Advancements in digital health technologies and the COVID-19 pandemic-when in-person visits were limited or unavailable for many trial participants-have accelerated the broader adoption of these activities,” said FDA Commissioner Robert M. “The FDA has long considered the benefits of decentralized clinical trials. ![]() This draft guidance builds on agency recommendations issued in 2020, which provided clarity for investigators to facilitate trial decentralization in response to the COVID-19 public health emergency and associated disruptions such as quarantines, site closures and travel limitations. We anticipate that this approach will facilitate the development of drugs including in areas of medical need, resulting in more treatment options and improved patient outcomes. By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges. Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant’s home using telemedicine.ĭecentralizing clinical trials will allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, instead of having them visit research sites. Today, the agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Food and Drug Administration is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
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