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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 clinicalresearch, 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.
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.
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinicalresearch, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinicalresearch encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.
Clinicalresearch is an integral component of the healthcare ecosystem. The success of clinicalresearch hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in ClinicalResearch: Perception Over the Years In the U.S.,
FDA’s informed consent guidance gets a 21st century makeover The FDA has issued a new, final guidance on informed consent for clinical investigations – the first update since 1998. The FDA, HHS, and research and informed consent policies In the U.S.,
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.
The researchinformed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed decision about whether to participate in a clinical trial. Why HIPAA in Research? PHI is a subset of what is termed “individually identifiable health information.”
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
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.
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.
However, do you really know what a CER is and how it evolved into the modern document required for the EU MDR (Medical Device Regulation)? In this post, we’ll explore the fundamentals of the Clinical Evaluation Report (CER).
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). RFIs must be addressed in the clinical trial information system (CTIS) within 10 calendar days for validation and 12 calendar days for assessment.
It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinicalresearch. Range of Services The range of services offered by a CDMO is another vital criterion.
Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What Does an IBC Review? appeared first on Advarra.
The draft guidance highlights several key points pertinent to international trials: Diversity of expertise: KOLs with varied backgrounds and expertise enhances the DMC’s ability to address complex clinical and safety issues, and is crucial for interpreting data accurately and making informed decisions. local standards of care).
Sit back and take a look at yourself, your life, and your depression – understand how things affect you, what situations may overwhelm you or exacerbate your depression, and take steps to improve your life and do what’s best for you based on that information. Sleep is especially important in regulating mood.
Global expertise and 7 key lessons learned The PPD clinicalresearch business of Thermo Fisher Scientific has extensive history working with PAH clinical trial sites globally (more than 3,500 sites across 53 countries in the past five years). From that experience, we offer seven key takeaways.
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.
FDA’s informed consent guidance gets a 21st century makeover The FDA has issued a new, final guidance on informed consent for clinical investigations – the first update since 1998. BY LAURA DIANGELO, MPHAUG 17, 2023 12:08 AM CDT The FDA, HHS, and research and informed consent policies In the U.S.,
To protect human subjects in clinicalresearch, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What Documents are in an eISF?
What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.
Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinicalresearch due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes. These changes can impact staffing requirements throughout the study.
While the regulations governing clinicalresearch refer to “noncompliance” several times, the term is not actually defined in the regulations. Note: This article was originally published December 4, 2019, and has been updated to include new and clarifying information.
This blog highlights some of the major proposed changes and how they may impact the clinicalresearch community. . Proposed changes to informed consent requirements include new basic elements similar to those included in the revised Common Rule. Again, this is similar to what HHS regulations currently permit. .
In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.
While we don’t know all the technicalities of what causes migraines on a neurological level, most scientists believe that they are the result of abnormal brain functioning, affecting your brain’s nerve signals, possibly the ones that regulate pain. Contact our office to be signed up to learn more information !
These companies are equipped with the expertise and resources to lead successful medical device clinical trials. Medical device sponsors often seek out CROs so they can outsource services such as clinicalresearch, site selection, trial design, and regulatory consulting.
The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinicalresearch and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.
IVDs are used in almost all clinicalresearch. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants. However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants.
In 2022, the global market value of patient portals within the clinicalresearch and healthcare industries was estimated to be US $2.9 To learn about the history of these trial technologies and their adoption within the clinicalresearch industry, read more here !
The underrepresentation of diverse groups in clinicalresearch is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”
Today, many clinicians and researchers acknowledge giving children drugs with no supporting pediatric research data and adjusting dosing based on weight likely isn’t the most effective way to treat them. The ethical way forward is to offer children [1] better opportunities to participate in clinicalresearch.
Every day, clinicalresearch organizations work to deliver a seamless user experience for their staff, while also providing robust security measurements to protect their data and stay compliant. Most large organizations have a simplified mobile experience to log in, authenticate, and access various platforms needed to conduct research.
Patient Education and Advocacy Collaboration : Making sure proper educational materials are available at sites and with patient advocacy organizations helps bring awareness to your trial and drive informed participation. These include ensuring informed consent, particularly around the risks and benefits of participation.
Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating Collaborating with patients plays a fundamental role, as each treatment discussion and decision-making process varies based on individual patients.
Introduction Patient-reported outcomes (PROs) refer to information about a patient’s health that is shared directly by the patient and not influenced by the interpretation of any other. Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinicalresearch.
Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. Amid a constantly evolving global regulatory environment, companies must be proactive, well-informed and flexible.
Clinicalresearch requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.
Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. This suppressive mechanism involves a negative regulator – a protein called IL-18BP or IL-18 binding protein, that works as a “decoy receptor” by binding to IL-18 and preventing it from binding to its functional receptor.
Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. Thus, while the same types of safety endpoints need to be evaluated, the studies done to do so often look different compared to those for a small molecule.
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.
Therefore, regulators and the industry must agree on accepted methods for analyzing data collected from wearable devices. Accessing structured, clean data is also a significant challenge because robust data-cleansing processes are typically required before clinical trial data can be used.
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