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Home » Authors » James Miessler

James Miessler

Articles

ARTICLES

Percent Increases

Number of Phase 3 Biotech Trials Increases 400 Percent Over Decade, Study Finds

November 13, 2023
James Miessler
From phase 3 trials to mergers/acquisitions and novel therapy approvals by the FDA, the biotech industry has seen a massive boom in the past decade. A new Tufts Center for the Study of Drug Development (CSDD) study reveals that the amount of biotech products in late-stage research has skyrocketed in the past 10 years, among other findings. Read More
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Options for AI in Clinical Research Abound, but So Do Challenges, Experts Say

November 1, 2023
James Miessler
The burgeoning AI space is bristling with potential for application in clinical trials, from study startup and recruitment to site monitoring visits, protocol simplification and greater operational efficiency overall. But widespread adoption will first require industry to properly evaluate and show the value of solutions in this still-evolving area. The CenterWatch Monthly reached out to several experts to gather insights on how AI is being used and what value it has for clinical trials. Read More
Interview

Increased Trial Access is a Global Effort, Technology Provider Says

November 1, 2023
James Miessler
Making clinical trials truly representative of the disease populations they target is not an effort confined solely to the U.S. and FDA; it is a global initiative with many considerations that differ by country, culture and regulatory agency. The CenterWatch Monthly interviewed Liz Beatty, cofounder and chief strategy officer at Inato, a tech provider focused on boosting trial inclusivity and access around the world, to discuss thinking from an international perspective on diversity, equity and inclusion (DE&I). Read More
DE&I

Operational Assessment Leads Takeda to Take DE&I Action in the Community

October 30, 2023
James Miessler
The diversity, equity and inclusion (DE&I) movement in clinical research has progressed significantly in the past few years, moving from discussing barriers and potential solutions in 2020 to taking real action this year and the last, LaShell Robinson, Takeda’s head of DE&I in clinical research, told attendees at the 2023 WCG Patient Forum last week. Read More
Obesity Treatment Patient

Clinical Trials Need Greater Representation of Obese Patients, Experts Say

October 23, 2023
James Miessler
Obesity’s impact on drug pharmacokinetics and the prevalence of the disorder and its associated comorbidities warrant greater inclusion of obese patients in clinical trials, experts say in a recent opinion piece, yet this group too often goes unconsidered and unevaluated. Read More

Make the TMF a Useful Part of the Trial Process, Not a Separate Endeavor, Expert Says

October 3, 2023
James Miessler
Problems can arise when sponsors isolate trial master file (TMF) management from the overall trial process by treating it as a separate activity. Utilize integrated technology to turn TMF management and procedures into opportunities to bolster trial success, a quality expert says. Read More
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Patients’ Interest in Trials Varies by Education, Income Level, New Study Shows

October 3, 2023
James Miessler
Diversity, equity and inclusion efforts need to look beyond racial, ethnic and geographic factors, according to a new study that shows a strong correlation of education and income to familiarity with trials and interest in participating. Read More
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FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

October 2, 2023
James Miessler
The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More
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Education, Income Level Influence Trial Perceptions, Study Says

September 25, 2023
James Miessler
U.S. patients with lower education and annual household income are less interested in and familiar with participation in clinical trials, according to a new study that recommends examining such socioeconomic factors when planning trials. Read More
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Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

September 11, 2023
James Miessler
Four major industry groups shared their thoughts on the International Council for Harmonisation’s E6(R3) draft GCP guidelines, commenting on stakeholder engagement, diversity and service provider evaluations and pointing out areas that need greater detail. Read More
View All Articles by James Miessler

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