Despite decades of research, development of a treatment for stimulant use disorder remains elusive. Experts are now hunkering down to come with new approaches to overcome hurdles in clinical trial design and the selection of study endpoints.
In Search Of A Stimulant Use Disorder Treatment: ‘We’ve Been Doing It Wrong’
US FDA official questions whether problem is due to population selection, outcome measures, or study duration. Potential endpoints include change in disease status as measured by DSM-5 criteria, cognitive function and quality of life, experts say.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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