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
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
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
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
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
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
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
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
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
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
