The European Medicines Agency (EMA) has released a draft guideline revision on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias for a six-month public consultation.
The EMA considers dementia a key public health priority and sees early stage intervention and prevention of symptomatic disease as particularly worthy goals.
This guideline aims to provide guidance for the evaluation of any medicinal product for treatment across the AD continuum. Creating such a document is an ambitious task as the research field is rapidly evolving. The guidelines cover basic regulatory requirements for patient selection, as well as characteristics, biomarkers and tools for outcome assessment and efficacy endpoints. However, which methodologies to use are left open to the researchers’ discretion.
The EMA acknowledges at this point that no single biomarker or tool can be endorsed over the others, and that there is no “gold standard”. This approach does not offer confirmatory guidance for the design of a clinical trial in AD, as is often sought from regulatory agencies. On the positive side, this approach does not restrict scientific development, as may have been the case in the past when overly stringent regulatory requirements hampered the incorporation of scientific progress into regulatory clinical trials.
As the field is rapidly changing and common knowledge is being amassed, the EMA strongly encourages requests for scientific advice on specific recommendations or qualification procedures. If you are seeking such advice, QPS can help make your interaction with the EMA be as stress-free and productive as possible. Our regulatory specialists will help you place your questions in the correct regulatory context, guide you through the scientific advice procedure, and even arrange your meeting with EMA.