The agency estimates that 88 sponsors will develop approximately 132 monitoring plans annually, as recommended in FDA’s draft guidance on oversight of clinical investigations; CDER will not be conducting prospective reviews of these plans but may do a pilot program in the future.
FDA has come up with an estimate of the burden of creating monitoring plans as called for in its draft guidance on the oversight of clinical investigations, which recommends that sponsors develop a prospective, detailed plan that describes the monitoring methods, responsibilities and requirements for each clinical trial.
The agency expects that 88 sponsors will develop approximately 132 comprehensive monitoring plans annually and that it will take approximately...
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
