The European Medicines Agency (EMA) released a report on Tuesday that analyzed over 100 applications submitted for medicines in the fields of psychiatry or neurology between 1995 and 2014. In the report, EMA concludes that various challenges can arise in the development of medicines targeting central nervous system (CNS) disorders and stresses the importance of appropriate design of early-stage clinical trials for future development success.
Complexity of research for CNS medicines adds to the challenge of successful drug development; EMA cites a “higher rate of failure during the clinical development of these products compared to other fields of medicine” in their report. Of the 103 applications received by EMA’s Committee for Medical Products for Human Use (CHMP), 57 were neurology products and 46 were psychiatry, and 29 were rejected or withdrawn leaving 74 that received approval. Submitted drugs targeted schizophrenia, MDD, Alzheimer’s disease, epilepsy, and more.
EMA’s claim that appropriate design of early-stage clinical trials is not ungrounded in fact. The analysis explains that “over 50% of the applications that had major problems with the outcome confirmatory study (in terms of efficacy and/or safety) also had issues in the early clinical development.” The chart below visualizes the report’s findings and the differences in the types of issues raised for neurology medicines and psychiatry medicines.
Appropriate design of early-stage clinical trials is vital for resulting in efficacious results, and Pearl IRB is here to help. Please contact us to set up a discussion with our team of experts to assist with your drug or device clinical trials.