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Home » Authors » James Miessler

James Miessler

Articles

ARTICLES

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

Site Spotlight: Revival Research Takes Screening to the Street at Outdoor Art Fair

September 1, 2023
James Miessler
Art and clinical trials proved a winning combination when Revival Research Institute took its screening operation to the largest art fair in the U.S. and returned with results that far exceeded everyone’s expectations. Read More
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FDA, Experts Talk Today’s Diversity Challenges in Oncology and Pathways Forward

September 1, 2023
James Miessler
Diversity has become ingrained as a priority in the oncology space, but industry could get stuck discussing existing barriers without formulating clear plans for taking action. FDA Oncology Center of Excellence (OCE) officials, sponsors and the American Association for Cancer Research (AACR) discuss these hurdles and potential next steps at length in a recent Clinical Cancer Research journal article. Read More
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Partnership to Bolster Trials in Low Resource Regions Kicks Off

August 28, 2023
James Miessler
With a mission of spurring strong randomized controlled trials, a quartet of trial networks have teamed up in a new program to encourage and support the use of key scientific and ethical principles in research conducted in Latin America, Southeast Asia and South Africa. Read More
Clinical Research

EMA Proposes Actions to Strengthen Clinical Research During Public Health Crises

August 14, 2023
James Miessler
The European Medicines Agency (EMA) has leveraged lessons learned from the COVID-19 pandemic and monkeypox outbreak to identify potential strategies for running trials efficiently and effectively during public health emergencies, especially plans for improved communication among member states. Read More
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Industry Feedback: FDA’s DCT Guidance Lacks Depth on Oversight, Task Log

August 7, 2023
James Miessler
The FDA’s draft guidance on conducting decentralized trials (DCT) needs more detail on oversight of and responsibility for providers of remote services, according to comments from industry groups and sponsors. Read More
View All Articles by James Miessler

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