ICON plc’s Post

Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. Ensuring participant safety requires strategic planning at multiple levels, from protocol and dose escalation to personnel training. ICON is continuously implementing proactive participant safety measures to effectively mitigate risks in early phase studies, with regular safety drills being performed by both clinic and hospital staff to ensure highly coordinated response and execution. We have also introduced the Modified Early Warning Score (MEWS) - this is designed to identify disturbances in vital parameters and prevent further serious risk to the trial participant. Read our blog to find out more. https://ow.ly/eG6x50StFvZ #earlyphase

Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. Ensuring participant safety requires strategic planning at multiple levels, from protocol and dose escalation to personnel training. ICON is continuously implementing proactive participant safety measures to effectively mitigate risks in early phase studies, with regular safety drills being performed by both clinic and hospital staff to ensure highly coordinated response and execution. We have also introduced the Modified Early Warning Score (MEWS) - this is designed to identify disturbances in vital parameters and prevent further serious risk to the trial participant. Read our blog to find out more. https://ow.ly/eG6x50StFvZ #earlyphase

Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. Ensuring participant safety requires strategic planning at multiple levels, from protocol and dose escalation to personnel training. ICON is continuously implementing proactive participant safety measures to effectively mitigate risks in early phase studies, with regular safety drills being performed by both clinic and hospital staff to ensure highly coordinated response and execution. We have also introduced the Modified Early Warning Score (MEWS) - this is designed to identify disturbances in vital parameters and prevent further serious risk to the trial participant. Read our blog to find out more. https://ow.ly/eG6x50StFvZ #earlyphase

Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. Ensuring participant safety requires strategic planning at multiple levels, from protocol and dose escalation to personnel training. ICON is continuously implementing proactive participant safety measures to effectively mitigate risks in early phase studies, with regular safety drills being performed by both clinic and hospital staff to ensure highly coordinated response and execution. We have also introduced the Modified Early Warning Score (MEWS) - this is designed to identify disturbances in vital parameters and prevent further serious risk to the trial participant. Read our blog to find out more. https://ow.ly/eG6x50StFvZ #earlyphase

Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. Ensuring participant safety requires strategic planning at multiple levels, from protocol and dose escalation to personnel training. ICON is continuously implementing proactive participant safety measures to effectively mitigate risks in early phase studies, with regular safety drills being performed by both clinic and hospital staff to ensure highly coordinated response and execution. We have also introduced the Modified Early Warning Score (MEWS) - this is designed to identify disturbances in vital parameters and prevent further serious risk to the trial participant. Read our blog to find out more. https://ow.ly/eG6x50StFvZ #earlyphase

You may have seen news about the FDA's new initiative, the Quantitative Medicine Center of Excellence from the Center for Drug Evaluation and Research [CDER]. In line with this, the FDA is hosting a free workshop on Apr 25th from 9 am to noon, US East Coast time. Here is a link to the workshop and to the free registration: https://lnkd.in/gP83xVde The workshop has a two-fold objective: [1] To provide an overview of the newly formed Quantitative Medicine [QM] Center of Excellence [CoE], including a discussion of current goals, initiatives, and priority areas and [2] To engage with stakeholders to inform future QM CoE initiatives in education, outreach, and policy development. The meeting materials can be found here: https://lnkd.in/gUjZXXCy

FDA Draft Guidance Released: “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice.” Purpose: Streamline protocols and procedures for RCTs, focusing on essential data collection. Integration: Allows research to be integrated into routine clinical practice. Traditional RCTs: Collect extensive patient data at baseline and during the trial. Routine Data Use: Health care professionals can use routine clinical data to meet trial requirements. Benefits: Reduces need for dedicated trial sites. Minimizes duplicate data entry. Enhances convenience and accessibility for participants. Allows for more diverse and representative populations. Produces more generalizable results. Applicability: New uses of FDA-approved drugs. Trials of unapproved drugs with well-characterized safety profiles. FDA’s Goal: Advance innovation in clinical trial design and conduct.

Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence   📅 DATE: April 25, 2024 | 9:00 AM - 1:00 PM ET ▶ LOCATION: Zoom   The FDA's new Center for Drug Evaluation and Research (#CDER) Quantitative Medicine Center of Excellence (CoE) is hosting a virtual #workshop to introduce the #CDER QM CoE, providing an overview of the scope, goals, and current state.   #QuantitativeMedicine (QM) uses exposure-based, #biological, and quantitative #models from various data sources to enhance #drugdevelopment #regulatory decisions, and #patientcare.    Workshop objectives: 📌 Provide an overview of the newly formed #QM CoE, including discussion of the current goals, initiatives, and priority areas 📌 Engage with stakeholders to inform future QM CoE initiatives in education, outreach, and #policy development   ✍ Register here: https://lnkd.in/g4YWZEDg

Finally a very cool Update from the FDA! The FDA has made a new team called the CDER - Centre for Clinical Trial Innovation (C3TI). This team will help people who are working on new ways to do trials. They’re focusing on: 1) Helping Pragmatic Trials 2) Bayesian Methods 3) Selective Safety Data Collection This is super exciting because it could lead to better ways of doing trials. If you’re working on a project, this could be really helpful! #Innovation #ClinicalTrials ⬇ Full Article here below ⬇

“As part of #FDA’s #RealWorldEvidence (#RWE) Program, this draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.” Comments by December 17, 2024. #rct #rcts #clinicaltrial #clinicaltrials #regulatory #regulatoryaffairs #pharma #clinical #clinicaldevelopment #randd #researchanddevelopment