New European documents with recommendations available for clinical trials

The European Commission has published three new documents with recommendations for clinical trials. The documents are the result of new European legislation (EU Clinical Trial Regulation 536/2014). Two of the documents are completely new, the other document is a revision of a previously available document.

The following documents with recommendations are available and applicable as soon as the Clinical Trial Regulation applies (expected in 2019):

  • Summaries of Clinical Trial Results for Laypersons (new)
  • Risk proportionate approaches in clinical trials (new)
  • Auxiliary medicinal products in clinical trials (revised)