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The FDA’s draft guidance on conducting decentralized trials (DCT) needs more detail on oversight of and responsibility for providers of remote services, according to comments from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
Oversight of data monitoring committees (DMC) and endpoint adjudication committees (EAC) can be handled most effectively by specialty third-party providers that can help bolster trial credibility and productivity while cutting down on risk, bias and perceptions of bias, says one expert. Read More
With the help of a multistakeholder task force that included the FDA, sponsors, sites, ethics committees and patient advocates, the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard has published a toolkit that lays out critical ethical considerations for decentralized trials (DCT). Read More
Application of risk-based quality management (RBQM) is still limited in trials, according to new data that show sponsors and CROs use RBQM elements in about half of trials overall and hold varying perceptions of their benefits. Read More
CROs’ performances in areas pivotal to sites have been on a notable decline since at least 2019, sites reported in WCG’s 2023 Global Site Relationship Benchmark Survey, echoing a similar downward trend for sponsors. Read More