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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.
However, getting essential treatments to patients quickly and safely requires more than just technological innovation. A global network with local expertise To ensure the delivery of treatments to patients worldwide, biotech and biopharma companies also need partners that can provide comprehensive solutions from a geographic perspective.
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 clinicaltrials, which judiciously test and evaluate safety and efficacy.
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.
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.
Though they do positively impact patients’ quality of life and hemodynamic parameters, these treatments — prostacyclin analogs and receptor agonists, phosphodiesterase 5 inhibitors, endothelin-receptor antagonists, and cGMP activators — have shown limited beneficial effects on survival and disease progression.
Today we want to set the record straight by raising awareness about HS and sharing some important facts surrounding the causes, symptoms, and treatment of it. Finding treatment for Hidradenitis Suppurativa is tough. . Treatment methods often focus on symptom management, and can vary in effectiveness from patient to patient.
A surrogate endpoint is a marker used in clinicaltrials as a substitute for a direct clinical outcome. Susceptibility or risk biomarkers can detect the likelihood of a patient developing a disease or medical condition, which is crucial for treatments that are most effective before the onset of symptoms.
“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.
From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. In response, the PPD clinicalresearch business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.
Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. This limited pool poses significant barriers to conducting statistically significant studies and validating the efficacy and safety of new treatments.
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.
Clinicaltrials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. In Tampa Bay, Olympian ClinicalResearch is at the forefront of this vital work, offering local residents the opportunity to contribute to medical advancements.
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.
Many of the life-changing medical treatments that are available for patients have all been tested through a research study. There’s no doubt that research volunteers play a significant role in getting these vital solutions out on the market for the people in need. What is a clinicaltrial?
Achieving diversity, equity, and inclusion (DEI) in clinicaltrials 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.
Reaching the end goal of delivering transformational new treatment options for patients can take a decade or more even when companies execute successfully and are well capitalized. While we are excited by the progress we have made in a short time, we also considered how we could possibly further accelerate and de-risk our development efforts.
As the pharmaceutical and biotech industries continue to push for faster drug development, the importance of equity and diversity in clinicaltrial recruitment cannot be overlooked. With the rise of digital health and data, there are endless possibilities for reaching vulnerable populations and improving access to treatment.
The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. However, the treatment journey does not end with weight reduction, as maintaining weight loss overall is equally crucial.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Your CRO can also play a crucial role in helping you to understand existing precedents and how they apply to your study and overall development journey.
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.
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. Both groups agreed that reluctance toward research is a prominent barrier. Specifically, U.S.
At Olympian ClinicalResearch we’ve gotten a chance to work with countless Schizophrenia patients over the years through our clinicaltrials, and we know just how untrue many of the common assumptions about Schizophrenia really are. . Myth #2: People with Schizophrenia are violent. Learn More.
Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases.
As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. Psychedelic Research at Worldwide Since 2017, Worldwide ClinicalTrials have supported a myriad of sponsors leading the way in psychedelic research programs.
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.
Four Pain Models Altasciences Uses to Assess Treatments During ClinicalTrials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.
If you’re thinking about joining a clinicaltrial, there are many benefits you could look forward to. But how can you tell if clinicaltrials are right for you? We’ve outlined five reasons why joining a clinicaltrial might be in your best interest. You’ll Get Great Medical Care.
Clinicaltrial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. The industry faces several persistent hurdles: Data fragmentation: Research teams often struggle with siloed information across departments, hindering collaboration and comprehensive analysis.
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.
Participating in a clinicalresearch study can have many benefits. From offering specialized care to providing participants with potential new treatment options, finding the right clinicaltrial can lead to positive outcomes for today’s patients and unlock breakthroughs for those diagnosed in the future.
Tissue biopsies have long been a cornerstone of clinicalresearch, providing researchers with direct access to diseased and healthy tissue for analysis. In recent years, their role in clinicaltrials has expanded, offering invaluable insights into disease mechanisms, drug efficacy and personalised treatment strategies.
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.
In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinicalresearch and drug discovery. This can be converted to a clinicaltrial simulator, which can model a clinicaltrial before the trial design is finalized and initiated.
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%
Managing clinicaltrial budgets efficiently is necessary for the success and sustainability of clinicalresearch sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).
The increased adoption of decentralized clinicaltrial (DCT) designs has revolutionized how the industry approaches clinical studies. In short, for clinicaltrial design to truly benefit from the digital revolution, data flow, management and analysis are the next frontiers.
Before any new medical treatment, therapy, or device is approved, it must first be tested through clinicalresearch studies. While some research studies seek participants with illnesses or conditions to be studied in the clinicaltrial, it is not always necessary to have a specific illness or condition to participate.
Obesity treatment is undergoing a major shift, much like the advances seen in cancer care. Phenomix Sciences , led by CEO Mark Bagnall, is using precision medicine to make treatments more targeted and effective. Phenomix Sciences, built on over a decade of clinicalresearch at the Mayo Clinic, is disrupting this outdated approach.
One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinicaltrial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinicaltrials.
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.
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinicaltrials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.
Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.
As therapies for the treatment of NASH in adult patients go this year to the U.S. Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Partnership with an experienced CRO is essential to your trial’s success. Hispanic: 11.8%
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