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The new MHRA scheme helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.

Objective To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care. Design Randomised controlled trial. Setting Participants’ homes and communities at five sites in the United Kingdom. Participants 365 adults with early dementia or mild cognitive impairment who were living at home, and family members or carers. Intervention The intervention, Promoting activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED), was a specially designed, dem...

In low- and middle-income countries, poverty and impaired growth prevent children from meeting their cognitive developmental potential. There are few studies investigating these relationships in high-income settings. Participants were 12,536 children born between 2000 and 2002 in the UK and participating in the Millennium Cohort Study (MCS). Short stature was defined as having a height-for-age 2 or more standard deviations below the median (≤ − 2 SDS) at age 3 years. Standardized British Abilities Scales II (BAS II) language measures, used to assess language de...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation to improve and strengthen UK clinical trials legislation.

Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.