Study shines a light on representation in clinical research
Drug Discovery World
FEBRUARY 8, 2023
The post Study shines a light on representation in clinical research appeared first on Drug Discovery World (DDW).
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Drug Discovery World
FEBRUARY 8, 2023
The post Study shines a light on representation in clinical research appeared first on Drug Discovery World (DDW).
Quanticate
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Understanding and navigating the regulations surrounding audit trail review is essential for all CROs, Biotech’s and Pharma’s to ensure that compliance is maintained, and that auditors and regulators can be reassured that the clinical data meets all the necessary standards.
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Drug Discovery World
DECEMBER 18, 2023
Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.
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Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Dr Olena Karpenko.
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A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”
Advarra
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Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.
Advarra
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In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.
Vial
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Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,
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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2
Drug Discovery World
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Dr June Raine, MHRA Chief Executive, said: “Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”
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It could also encourage more investment in the space and make us better partners to regulators and payors alike. The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.
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In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.
PPD
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The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.
Chemical Biology and Drug Design
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Kaempferol exerted antioxidant effects in AR-DOR by inhibiting Hsp90 to up-regulate Nrf2. In this study, 36 volunteers and 78 DOR patients (37 patients with EXD treatment) were enrolled in the clinical research. This study provides a theoretical basis for the clinical application of kaempferol in AR-DOR.
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Global Cancer Segment Market Manager at Agilent Technologies, recently sat down with DDW Editor Reece Armstrong to tell us about the developments in the ‘golden age’ of cancer research. RA: What is the current state of the cancer research industry? RA: How is Agilent supporting cancer research? Mark Garner, PhD.,
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With all these incredibly diverse and complex research datasets, how do we sift through them to find those golden insights that can lead to more efficient clinical trials and, ultimately, better healthcare outcomes? How do we move past the daunting 95% failure rate 2 we encounter in clinical trials?
Agency IQ
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At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans.
Quanticate
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The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.
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PPD
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31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.
Drug Discovery World
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Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S.
Drug Discovery World
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Sano Genetics, a software company working to accelerate precision medicine research, has raised $11.4 Access and referrals for patients to join trials often depend on the hospital or location where they’re receiving treatment – which is why recruiting for clinical trials is one of the biggest challenges in research.
Advarra
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While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Understandably, this can cause confusion for researchers working with multiple IRBs. The post Reporting to the IRB: Investigator Noncompliance appeared first on Advarra.
Drug Discovery World
SEPTEMBER 23, 2022
An interesting week for clinical research and drug approvals, with rare diseases being a key focus for both the FDA and European Commission. Breast cancer cells ‘regulate their own metastases’. News round-up for 19-23 September by DDW Editor Reece Armstrong.
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Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.
PPD
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Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges. Rebadge staffing is a critical part of an FSP model in clinical research. What is rebadging in an FSP model?
Agency IQ
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FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.
Conversations in Drug Development Trends
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Drug Discovery World
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Drug Discovery World
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Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.
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Why are cancer treatments for children lagging behind the latest advancements in clinical oncology? Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids.
Agency IQ
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The new guidance offers recommendations for institutional review boards (IRBs), investigators and sponsors on key aspects of informed consent, significantly expanding FDA’s recommendations on several key topics, including reimbursement for research participation. The FDA, HHS, and research and informed consent policies In the U.S.,
Vial
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However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products. This is where contract research organizations (CROs) come into play.
Olympian Clinical Research
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Whether it’s aging , acne , or hyperpigmentation, these products are formulated based on clinical research and are proven to deliver results. Safety and Efficacy Medical Grade Skincare is Backed by Science Medical-grade products undergo rigorous testing and are backed by scientific research, ensuring they are both safe and effective.
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Vial
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In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.
PPD
AUGUST 16, 2023
However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Fortunately, leading global regulators have launched key initiatives.
Vial
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Drug Discovery World
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While traditional approaches to clinical trials have helped us manage some of these conditions to a certain extent, they alone may not provide us the velocity we need to accelerate the research and conquer these diseases, raising the possibility that technologies such as artificial intelligence (AI) may hold the answer.
Advarra
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But for the nusinersen clinical trials, children were most likely to benefit, and so the clinical trials began without first collecting data on adult research participants. Even though this was a big step for involving children in clinical trials, kids haven’t always been as fortunate. Why This Guidance Now?
Perficient: Drug Development
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The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research. Reach out to connect with us.
Advarra
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There’s no doubt eSource has the potential to streamline the process of clinical research by improving efficient and accurate data collection. However, adopting eSource is challenging for many research facilities. Research sites may elect to collect data using eSource, paper source, or a combination of the two.
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