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Clinicaltrials are expensive, slow and often limited by outdated design constraints.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.
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?
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. This presents three core conflicts: Opaque provenance: The data used to train the model is not transparent.
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.
For many people, participating in a research study presents an interesting opportunity with many benefits to volunteering. While there are many types of clinicalresearch, all with distinct goals and timelines, trial volunteers will follow a similar path when taking part. Read on to learn more about the process.
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.
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 the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.
Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.
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.
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
The field of clinicalresearch is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinicalresearch conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.
Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinicaltrials. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.
Acceleration in every step of clinicalresearch is critical to pharmaceutical developers. Yet, today’s clinicalresearch sponsors face significant challenges. Rather than accepting the persistent delays in clinicalresearch as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.
“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.
Advancements in preclinical and clinicalresearch are driving major changes across various therapeutic areas, steering the industry into a new phase of medical innovation. Our aim is to provide valuable insights for industry professionals, stakeholders, and all those invested in the future of medical science.
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinicaltrials.
There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation.
In clinicalresearch, access to timely, curated data is critical to mitigate risk and drive operational effectiveness. One common challenge for clinicaltrial sponsors is coordination of data across an array of vendors and systems. Expertise to easily assimilate diverse data systems and anticipate gaps.
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.,
This is in contrast to reactive deprescribing, which is stopping a medicine in response to present harm, e.g., when side effects of a medicine cause a person to fall. Why is the CHARMER trial important? The CHARMER trial aims to i ncorporate proactive deprescribing as a routine aspect of care in Older People’s Medicine wards.
NCCRED was funded through the Strategy, and commenced in 2018, to build clinicalresearch capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinicalresearch priority setting study?
For many patients, involvement in oncology clinicaltrials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.
As Phase 1 clinicaltrials include several different design types with multiple objectives (e.g. png Listing Introduction Join this webinar to receive expert guidance and learn key considerations for successfully planning pharmacy activities in early phase trials. Listing Image DrVince_ListingLogo_250x190.png
In this interview, she discusses her path to becoming a physician and clinicalresearcher, the obstacles she faced, and her dedication to improving outcomes for cancer patients. Dr Hingorani also shares insights into the strengths women bring to STEM, the importance of mentorship, and her vision for the future of oncology research.
The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinicalresearch business of Thermo Fisher Scientific.
Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinicaltrial.
The clinicalresearch industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinicaltrial process is both expensive and time-consuming, and ends more often in failure than success. Advarra surveyed 1,000 random U.S. In total, 82.8%
In a recent webinar, Challenges of Drug Development 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.
The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom.
As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinicaltrials in collaboration with a pharmaceutical partner. You can learn more about how clinicaltrials work here.
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 clinicaltrials and introduce automation in drug discovery.
Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinicalresearch. PROs in clinicaltrials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.
As the clinicaltrial landscape evolves, drug developers 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 drug developers.
In an industry survey led by PPD, Thermo Fisher Scientific’s clinicalresearch business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.
The success of clinicaltrials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Specifically, U.S. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership.
AMCs and Health Systems Integrating a clinicaltrial management system (CTMS) enables the regulatory team to pull protocol details and place them into eReg. This saves staff members time since they do not have to look up individual records to make sure credentials are present for each one.
Finding the right patients, connecting with the right sites and leveraging the right expertise present challenges. To be competitive, drug developers must run their trials efficiently and within budget and timelines, while still maintaining quality to support authorization.
ClinicalTrials: Pritelivir is currently in phase II clinicaltrials, with ongoing research into its effectiveness and safety. ClinicalTrials: Pritelivir mesylate is currently under extensive study to evaluate its efficacy and safety profile, with promising results in early clinicaltrials.
In the context of decentralized clinicaltrials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinicalresearch site. What is this innovation?
Clinicaltrials are needed to determine whether a medical device can produce sufficient proof of its efficacy. However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinicaltrials for their products.
The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinicaltrials. However, BLRM tends to be more conservative compared to other Bayesian designs, prioritizing patient safety above all else.
When participating in clinicaltrials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. Five Strategies to Tailor Your Pediatric ClinicalTrials to the Child’s Needs 1.
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