Presenters at the IFT Wellness conference recommend that nutrition science move beyond randomized controlled trials – which typically are ill-suited to assess nutrient benefits – so development of new food and supplement products is not impeded.
Nutrition scientists say research to support nutritional health claims should not be limited by randomized controlled trials – the so-called gold standard of evidence that has yielded disappointing results linking nutrients to health benefits.
Rather, researchers and regulators should consider measuring the physiological effects of nutrients in the body or simply accepting a lower...
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
