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The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH.
Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinicalresearch for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.
Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinicalresearch, and how did you enter the field? We used drugs we developed in adults off-label in children.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinicalresearch? This new guidance will clearly impact the clinicalresearch field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinicaldevelopment?
Change management is an overarching theme in innovation, with a need to mitigate and resolve barriers to change due to low institutional and personal risk tolerance, says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, at the FDA Center for Drug Evaluation and Research (CDER).
Eisai has entered a comprehensive research partnership agreement with Washington University School of Medicine in St Louis, US, to develop potential new therapies for neurodegenerative ailments. Under the deal, the parties intend to develop treatments for diseases including Alzheimer’s and Parkinson’s.
Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development.
Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinicalresearch, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinicalresearch.
Clinicalresearch has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
Clinicalresearch involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinicalresearch.
With nothing more than a drop of blood, medical specialists could soon have years of advance warning that the disease is developing. As treatments for multiple sclerosis (MS) continue to improve, scientists are looking for ways to spot the condition before symptoms set in. MS affects nearly a million people in the US alone, whose […]
Stephen Apps discusses how technology can help improve the speed and quality of clinicalresearch and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.
Despite these advancements, challenges for widespread effective care remain due to the heterogeneous patient population, opening the door for further development of treatments for T2D. Obesity is a major factor in the prevalence of T2D, and it is vital to develop T2D treatments with this in mind.
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You have the oversight you need.
Hanger encourages new clinical trial professionals to embrace innovation and stay patient-focused. She hopes her work at CTTI will influence the development of a clinical trial system that is more efficient, inclusive and better aligned with patient needs.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.
COVID sent us into a series of lockdowns in a bid to control the spread of the virus until a vaccine could be developed. The world changed for all of us when we were suddenly plunged into a pandemic in 2020. Most of us knew that a vaccine would be the key to our post-pandemic […]
If theres one thing clinicalresearchers can count on when it comes to regulations and guidance from governing bodies, its change. Its a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country. This is a sponsored message.
Frances Broyles and Dr. Sheryl Marks of Rainier ClinicalResearch Center offering valuable insights to help you make an informed decision about participating in this critical step toward advancing healthcare.
She celebrates how healthcare professionals have an exceptional power to transform lives, and will share her perspective on how compassionate care can be incorporated into clinicalresearch in a Signature Series keynote session tailored for attendees of ACRP 2025 in New Orleans, La., in April. I wanted to feel peaceful.
Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.
ACRP reached out to experts from graduate programs in clinicalresearch for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself. This diversity suggests varying levels of prior research experience and knowledge.
Also sharing advice on breaking free of unproductive habits on Saturday was Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Consultant and Owner of Responsibility Research, in her session on “The Intersection of Technology and People: Harnessing Technology to Increase Efficiency and Build Relationships.” On Day Two of ACRP 2024 in Anaheim, Calif.,
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
A team of researchers led by Johns Hopkins Bloomberg School of Public Health epidemiologist Jason Smith has found improvements to common vision problems could potentially prevent as many as […]
a global leader in analytical and clinical laboratory technologies, announced that it has received two prestigious awards from SelectScience: Best New Drug Discovery & Development Product of 2023 and Drug Discovery & Development Webinar of the Year. Agilent Technologies Inc., The […]
The Drug Discovery & Development Workshop 2024 is set to be a cornerstone event for professionals and students in the pharmaceutical and biotechnology sectors.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
As drug companies have embarked on an initiative to launch affordable medicines for rare diseases in India, experts have called for using pharmacogenetics to develop treatments and whole genome sequencing to identify etiologies.
The Indian Council of Medical Research (ICMR) has announced a Request for Expressions of Interest (EoI) aimed at inviting researchers, academicians, and scientists to participate in the formulation of evidence-based guidelines for the empirical use of antibiotics in the management of sepsis, dental infections, and vaginal discharge.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
In the US, African American women are more likely to develop lupus than white or Caucasian women. In a 29 March press release, the FDA stated that Lupus ABC will bring voices together in a centralised forum to define challenges in drug development and analyse potential approaches to help advance therapies.
Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinicalresearch. Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinicalresearch.
The advent of outsourcing in clinicalresearch came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. Instead, a CRO offering consultative services and strategic development elevates the full development program.
A group of researchers at the Kolkata-based S N Bose National Centre for Basic Sciences has developed non-invasive method of recognising breath patterns that can help rapid, one-step diagnosis and classification of various gastric disorders like dyspepsia, gastritis, and gastroesophageal reflux disease (GERD).
Our new research shows what happens to the brains and behavior of young teenagers, years after they’ve become “night owls” We found this shift […]. It’s 11 pm on a weeknight and your teenager still has their bedroom light on. You want them to get enough sleep for school the next day, but it’s a struggle.
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