Whether US FDA may need to create a special labeling section for patient experience data is a ‘huge question that’s going to require a lot of discussion,’ Oncology Center of Excellence’s Kluetz says; agency is currently exploring non-labeling alternatives to communicating PRO data.
The growing interest in patient-reported outcomes may require FDA to come up with new ways to incorporate such data in drug labeling as it also explores alternative methods for communicating this information to patients.
At an April 25 workshop on clinical outcome assessments in cancer trials, FDA officials said the agency is trying to...
The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.
Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.
ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.
Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
