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As clinicaltrials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinicaltrial management.
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drugdevelopment. It demands a comprehensive, collaborative approach that reduces complexity and allows for just-in-time decision-making throughout the drugdevelopment journey. billion in 2023 to 1.2
It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinicaltrials. This has led drugdevelopers to unintentionally limit their potential within chosen therapeutic spaces.
As the pharmaceutical industry continues to evolve, drugdevelopers encounter new challenges and opportunities in their pursuit of innovation. From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape.
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.
Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. Developing effective ECs requires more than just matching clinicaltrial inclusion and exclusion criteria within the RWD source.
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 clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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 clinicaltrial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
Our annual look at the state of the drugdevelopment industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.
Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.
Clinicalresearch generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.
Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinicalresearch. These domains are ripe for innovation. Errors jeopardize patient safety, regulatory compliance and trust.
A recent white paper from the PPD clinicalresearch business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinicaltrials.
Its ability to maneuver persistent drugdevelopment challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. FSP outsourcing is growing faster than FSO.
Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drugdevelopment. Opportunities in clinicalresearch and drugdevelopment were not always easy to come by.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
It takes a family to develop a drug Trembles role at Poolbeg is multifaceted, reflecting the collaborative ethos of the companys scientific team. I take responsibility for identifying pre-clinicalresearch that can support our clinical programs, as well as designing and overseeing its execution, he explains.
Its important for your clinicalresearch organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.
Biopharmaceutical and biotech drugdevelopers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinicaltrial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6
Phenomix Sciences, built on over a decade of clinicalresearch at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall.
The complexity of diagnosing IPF, understanding its root causes, and translating preclinical findings to clinical success make it a challenging disease for drugdevelopment. However, recent advancements and strategic approaches in clinicaltrials offer hope that additional treatments are on the way.
One of the most important factors to consider during the course of your early-phase clinicalresearch is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.
In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.
Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinicaltrials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.
This expansion is creating opportunities for clinicaltrials related to a range of new therapy areas and their subpopulations. Participant fatigue in GLP-1 clinicaltrials The success of GLP-1 drugs in SELECT and other trials has biotech and biopharma companies racing to find which indications respond well to similar treatment.
In a recent webinar, Challenges of DrugDevelopment in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
In contrast, an adaptive trial design allows for modifications to an ongoing trial and its analyses under a pre-specified framework, which is outlined in the FDAs Adaptive Designs for ClinicalTrials for Drugs and Biologics Guidance for Industry, published in 2019.
Solid tumors present a significant challenge to clinicalresearch due to their complex and heterogeneous nature. Have you optimized your trial designs to employ precision medicine approaches for your novel solid tumor intervention? Request early access here for the white paper.
The event also featured a presentation from Dr. JP Clancy, CFF VP of ClinicalResearch, about the latest medical and scientific advancements to treat cystic fibrosis. Understanding Cystic Fibrosis According to the CFF , cystic fibrosis is a progressive, genetic disease that affects the lungs, pancreas, and other organs.
ClinicalResearch Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drugdevelopment process and conducting clinicaltrials. appeared first on ProRelix Research.
In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drugdevelopment.
As the clinicaltrial landscape evolves, drugdevelopers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. Decentralized Trials Digital and decentralized clinicaltrials (DCTs) continue to expand and have become a standard solution for drugdevelopers.
Clinicaltrials have significantly increased in complexity over the last 20 years, creating new challenges. One of the top reported challenges facing drugdevelopers today is recruiting, enrolling and retaining the right patients for studies. Virtual support can address some of these challenges cost-effectively.
Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinicaltrial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinicalresearch business of Thermo Fisher Scientific. There’s little time to lose.
Clinicalresearch is evolving as technology advancements enable more sophisticated drugdevelopment methods, dramatically increasing the speed, volume, and complexity of clinicaltrial data generation.
Approaches to outsourcing clinicaltrials have changed significantly in recent years. Mixing of service models — a strategy that drugdevelopers are leveraging now more than ever — can bring life-changing therapies to market faster.
PPD, Thermo Fisher Scientific ’s clinicalresearch business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drugdevelopment industry. The opportunity to leverage new technologies in drugdevelopment (e.g.,
Patient safety has been the primary focus of clinicaltrial design since 1947 when the Nuremberg code outlined the ethical guidelines for clinicalresearch. Trials must be designed to avoid injury or suffering and patients must give consent and are free to leave the trial at any point.
The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drugdevelopment. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinicalresearch and drug discovery.
By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drugdevelopment process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.
As the pharmaceutical and biotech industries continue to push for faster drugdevelopment, the importance of equity and diversity in clinicaltrial recruitment cannot be overlooked. Let’s dive in to uncover the role of digital health and data in driving faster drugdevelopment through improved diversity.
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drugdevelopment shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinicaltrial landscape in 2024. Five Predictions for the DrugDevelopment Industry in 2024 1.
The Sustainable Healthcare Coalition , a not-for-profit, health care sector-led group based in the United Kingdom, concluded that globally, clinicalresearch could generate the equivalent of 100 million tons of carbon dioxide (CO2) emissions each year. These results can then be used to enhance the accuracy of the predictive model.
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