Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation

Keyphrases

• Clinical Trial Regulation 100%
• Efficacy Data 20%
• Efficient Delivery 20%
• European Clinical Trials Regulation 40%
• European Countries 20%
• European Legislation 20%
• European multinationals 20%
• European Union 100%
• Incentivization 20%
• Investigator-initiated 20%
• Investigator-initiated Clinical Trial 20%
• Investigator-initiated Trials 20%
• Legal Requirements 100%
• Medical Knowledge 20%
• Medicine Regulatory Authority 20%
• New Medicines 20%
• Off-label Use 20%
• Pediatric 20%
• Pediatric Research 100%
• Pharmaceutical Companies 20%
• Requirements Challenges 100%
• Research Culture 20%
• Safety Data 20%
• Uniform Approach 20%

Pharmacology, Toxicology and Pharmaceutical Science

• Clinical Trial 100%
• Off-Label Use 12%