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The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinicaltrials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinicaltrials.
Despite advancements in neuroscience and psychiatry, clinicaltrials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges. Finally, psychiatry clinicaltrials must also address the variability in treatment responses.
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.
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.
In clinicalresearch, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinicaltrial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinicaltrial designs.
It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinicaltrials operator will be more than happy to resign to machines.
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.
In this episode, Vera spoke with Morgan Hanger, Executive Director of the ClinicalTrials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinicaltrials, with an ambitious “Transforming Trials 2030” vision.
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? So I’ve been working in that space about 43 years.
Clinicaldevelopment programs must acknowledge the complexity and variability of obesity as a condition. Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinicaltrial design is crucial for executing successful clinicalresearch.
The traditional clinicaltrials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinicaltrials, is aiming to enhance the efficiency and efficacy of clinicalresearch.
SinoMab BioScience intends to commence a Phase I clinicaltrial in China to evaluate SM17’s safety profile. The company dosed the first healthy participant in a Phase I clinical first-in-human (FIH) clinicaltrial in June 2022.
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinicaltrials but doing so can have huge benefits for the sustainability and success of research. Improving the design of commercial research by listening to the patient voice.
In clinicalresearch, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. Access to information: Limited resources and educational materials hinder informed decision-making about trial participation.
The clinicalresearch industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinicaltrial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S.
The push to increase diversity in clinicaltrials has gained momentum, but true progress requires more than regulatory mandates. In this webinar, industry leaders and patient advocates discussed how authenticity and the patient voice can be leveraged to enhance diversity in clinicaltrials.
To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinicaltrials. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinicaldevelopment. Cohen to the ClinicalTrial Podcast.
In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinicaltrials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”
Diversity in clinicaltrials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinicaltrial participation for underserved groups is an essential part of addressing health inequalities. Clinicaltrial participation, she went on, was vital.
Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinicaltrials are conducted. Expanding on data science skills drives the benefit of these technologies even further, turning them into powerful tools that can be wielded intelligently to reduce trial inefficiencies.
Today is ClinicalTrials Day 2021 — a day for recognizing the importance of clinicalresearch in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinicaltrial results and safety data.
Ora, a clinicalresearch organization (CRO) for ophthalmology pharmaceutical and device development, has partnered the North West London ClinicalTrials Alliance, to improve the quality and access to clinicalresearch in the region.
Pharma companies face many challenges when involving patients in the design of clinicaltrials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.
Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history.
Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinicalresearch and to better integrate clinicalresearch in the European health system.
Last year, we witnessed a significant milestone in oncology clinicaldevelopment, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.
The cloud software firmâs Digital ClinicalTrials Survey Report reveals that the industry is adapting to challenges caused by COVID-19 and other factors.
An expert from the institutional review board services company advises what trends to look for in the clinicaltrial industry over the course of coming months.
As the clinicalresearch landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. The post Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations appeared first on Worldwide ClinicalTrials.
Am expert from the CRO discusses unique challenges associated with running clinicaltrials that stretch across national boarders and how to conquer them.
The revolution in clinicalresearch is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinicaldevelopment is not only a moral imperative but a strategic necessity in modern medical research.
Patients are the backbone of clinicaltrials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinicaldevelopment of the findings.
Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinicaltrials. In CV clinicaltrials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.
In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinicaltrials. Data security: The clinicaltrial data is backed-up and secure.
When using genetic screening to identify clinicaltrial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. Read the full article!
Patient-centricity isn’t a catchphrase in clinicaltrials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, ClinicalTrial Financial Management Medidata Alicia C.
As clinicaltrials become more complex, the need for user-centric design has never been more critical. His commitment to enhancing user experience is transforming how clinicaltrials are conducted, ensuring that both patients and site staff are supported throughout the process.
Protocols drive every clinical study, guiding research teams from early inception through planning and into the trial’s execution. Clinicaltrial protocols are also very complex, with detailed schedules of assessments, inclusion/exclusion criteria and scientific reasoning all captured into a single written document.
Almost half (48%) of cancer clinicaltrials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. Figure 1: Ethnic composition of cancer clinicaltrial cohorts in the USA.
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinicaltrials. A 2018 NIH survey found that patients felt clinicaltrial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.
Just in time to help recognize Pride Month , ACRP’s ClinicalResearcher journal is pleased to share the first details from the lead peer-reviewed article on “Improving Cardiovascular Research for Transgender and Gender Diverse Populations” from a trio of WCG IRB expert contributors to the new issue going online today (June 13).
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