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Clinicaltrials are expensive, slow and often limited by outdated design constraints. They offer patient-specific outcome predictions, generated using machine learning models trained on real historical clinical data. Digital twins offer a way forward. Unlearn is one of the few companies applying this approach at scale.
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Decentralized clinicaltrials (DCTs) bring many benefits to the clinicalresearch process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.
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Connecting patients with clinicalresearch opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinicaltrial but to do this effectively, it’s critical to have accurate information.
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.
The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinicaltrial (DCT) models. At the end of 2022, the PPD clinicalresearch business of Thermo Fisher Scientific surveyed key leadership and staff on the frontline of clinicaltrial execution across the industry.
Accelerate your drug development and clinicaltrial goals and benefit from our 360° CDMO and CRO solutions and expertise. Partner with us The post Redefining Acceleration of the Drug Development Journey appeared first on PPD.
Clinicaltrials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinicaltrials requires efficient communication and coordination among various stakeholders.
Clinicaltrials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit. The increase in complexity isn’t just creating challenges for patients.
Composite endpoints might include factors such as hospitalization, transplantation and worsening of clinical outcomes. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.
In an era where clinicaltrials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinicaltrial’s safety and efficacy.
In recent years, the landscape of clinicaltrials has evolved significantly, particularly in oncology research. Two innovative trial designs that have gained prominence in Phase II are the basket and umbrella designs.
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.
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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.
Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinicalresearch.
Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. clinical operations, pharmacovigilance, regulatory) across various medicinal products, a portfolio of studies or the entire company.
“Patient-centric” is used frequently to describe today’s clinicaltrial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinicaltrial designs. Patient centricity has become more than a key consideration.
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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. In October, FDA announced seven new clinicaltrial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2
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.
AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinicaltrials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.
ClinicalResearch Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drug development process and conducting clinicaltrials. In this […] The post ClinicalResearch Organizations: Importance, Services, Selection Process and Future.
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. Here are some key requirements for “high risk” AI systems as they relate to clinicaltrials.
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.
From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinicaltrials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.
Navigating today’s rapidly evolving clinicaltrial landscape can be tough. With intricate protocols and shifting regulatory demands, it’s more difficult than ever to find and keep participants, as well as gather reliable data.
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Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinicaltrials.
A surrogate endpoint is a marker used in clinicaltrials as a substitute for a direct clinical outcome. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinicaltrials.
There are many clinicaltrial blogs out there, but what sets the best ones apart? Our favorites are the ones that don’t simply cover news — instead, they aim to be go-to sources for informed positions on how to improve the medical research process.
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.
In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.
Redefining vaccine trial recruitment Clinicaltrials are vital for developing safe and effective vaccines, but their success relies on overcoming recruitment challenges and ensuring diverse study cohorts. Discover innovative, data-driven recruitment strategies to ensure diverse, efficient, and high-quality vaccine trials.
Clinicaltrials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. Participating in a clinicaltrial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community.
By partnering with a contract research organization (CRO) that understands the challenges of liver disease clinicaltrials — and the complexities of working with pediatric populations — you can drive your treatment forward. Partnership with an experienced CRO is essential to your trial’s success.
Over the last decade, the clinicalresearch industry has seen investigator site models evolve, pushing contract research organizations (CROs) to think and collaborate more creatively. It is also important to ensure that the needs of investigators are met to provide a seamless clinicaltrial experience.
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