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Participant safety monitoring in Decentralized Clinical Trials

BayBiotech.NET Decentralized clinical trials should account for adequate processes for reporting medication errors and safety events...A well-organized plan must include training of participating HCPs on following study protocol processes for the reporting of adverse events. Not only should HCPs be made aware of the contact details of the study personnel, but participants should also be informed so they can reach out for medical assistance. A lot of these responsibilities to prepare the logistical details fall on the study sponsor; however, study Principal Investigators also remain responsible for working with local HCPs to monitor the clinical safety of the participants... Useful link: https://www.fda.gov/media/189263/download?attachment
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Investigational Product consideration element in a Decentralized Clinical Trial:

BayBiotech.NET I nvestigational Product consideration element in a Decentralized Clinical Trial: In any traditional clinical study, administration of the investigational product (IP) to the study participants should be performed under the supervision of the investigator or the delegate medical representative. If a clinical study is considering a decentralized clinical trial model, there are certain factors to be considered for IP administration. For IP that has a high-risk safety profile, especially in the immediate post administration period, may need on-site dose administration under close supervision of the protocol trained principal investigator. However, for IP with a defined safety and stability profile and with well-understood low risk characterization may be administered at local health care facilities, mobile research facilities or at study participant's home. Regardless, for an investigational product, a well-established chain of custody and well documented accountabilit...
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BayBiotech.NET Mobile Health App Interactive Tool If you are developing a mobile health app checkout the interactive tool  to figure out the federal regulatory, privacy and security laws that may apply to your App.  More than regulations might be applicable depending on the scope but this website links all relevant regulations on FTC website. Link:  https://www.ftc.gov/business-guidance/resources/mobile-health-apps-interactive-tool
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BayBiotech.NET International Compilation of Human Research Standards 2024 Edition is shared as a reference document that elaborates the guidelines that protects research participants in over 130 countries globally. This information is compiled by Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH) and U.S. Department of Health and Human Services (HHS).  Link: https://www.hhs.gov/sites/default/files/ohrp-international-compilation-human-research-standards-2024.pdf
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BayBiotech.NET Swift adoption of DCTs (decentralized clinical trials): a side effect of COVID-19 pandemic https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8093545/pdf/main.pdf
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BayBiotech.NET Interoperability is path to optimizing digital medicine In order to use big data, artificial intelligence to its full potential, interoperability is the key to success, although the concept compromises data privacy and might lead to challenges. Cures act and Health Interoperability supports evaluation of IT systems and build core capabilities to begin sharing data via APIs (application programming interfaces). 
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BayBiotech.NET When it comes to utilizing Artificial intelligence in healthcare, responsibilities and accountability is higher since human lives are at stake. Digitalization and application of artificial intelligence in the development of medicine is rapidly evolving and for the better to minimize the time and cost it takes to bring a medicine in the market. while application of artificial intelligence in biomedicine is evolving, so are the regulations around system securities, data protection and mapping cultural and geographical diversities. It would need the expertise both from the field of medicine development who have enormous experience working in the field for years and from the computational background of people who could leverage the expertise to apply and develop meaningful algorithms to make use of artificial intelligence in digital health. A good read is available on this link !
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Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!
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BayBiotech.NET WHO Guidance on Ethics and governance of artificial intelligence for health released in June of 2021 lays out the guiding principles for AI application to benefit public benefits. It also provides recommendations to ensure all users of AI health applications understand the guiding principles. Follow the complete guidance here.  
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Meaningful Life

Dear readers, We have a wealth of information on the internet on how to live a meaningful life and mantras to obtain desired results. Meaning of living a purposeful life is different for each individual. Each one's stake is different in life. In other words, we can say the purpose and intention of living a meaningful life are dependent on one's inner built and measure of happiness. For some it is about building purposeful connections; for some, it is about having wealth in life whereas for some it could be entirely different. For me, the definition of living a meaningful life does not come without putting myself first on top of my priority list. I have to be able to carve time for myself, be able to take care of my needs, priorities and extend this definition next to my close family members and friends. With that said, a good, healthy lifestyle has lately become a big focus of my agenda on a daily basis. Paying attention to what I eat, how much I eat, what I do to keep...
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Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying crit...
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