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The FDA’s draft guidance on conducting decentralized trials (DCT) needs more detail on oversight of and responsibility for providers of remote services, according to comments from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
Despite heightened efforts to improve and some significant progress, clinical trials still have a long way to go to reach the goal of diversity, equity and inclusion (DE&I), say FDA Oncology Center of Excellence (OCE) officials, sponsors and the American Association for Cancer Research (AACR), in a new report outlining diversity practices being used in oncology trials. Read More
Despite the push for greater use of risk-based quality management (RBQM) in clinical research, adoption of its most commonly used components by sponsors and CROs is limited and perceptions of their benefits are still varied, new findings show. Read More
The collection, use and submission of patient experience data (PED) still requires significantly more FDA guidance, clarification and support, big-name sponsors told the agency in response to a request for information and comments on the subject. Read More