Finding and implementing an appropriate design for early-stage clinical trials is critical to the future success of medicines for central nervous system (CNS) disorders, according to new analysis from the European Medicines Agency (EMA)
Finding and implementing an appropriate design for early-stage clinical trials is critical to the future success of medicines for central nervous system (CNS) disorders, according to new analysis from the European Medicines Agency (EMA) of over 100 applications submitted between 1995 and 2014.
The research, published on November 29 in Nature Reviews Drug Discovery, shows that a wide range of different challenges can arise in the development of medicines for CNS disorders and that research in this area is complex, with a higher rate of failure during the clinical development of these products compared to other fields of medicine.
The authors scrutinized the clinical development programs submitted to EMA and assessed by the Committee for Medicinal Products for Human Use (CHMP) as part of marketing authorization applications for new or existing medicines for a total of 103 applications, including 57 in neurology and 46 in psychiatry. Of these, 74 had a positive opinion following the scientific assessment by the CHMP and 29 were rejected or withdrawn. The diseases addressed included schizophrenia, major depressive disorders, Alzheimer’s disease, epilepsy, Parkinson’s disease and multiple sclerosis.
During the assessment, the CHMP identified issues around the efficacy of data for the medicines in more than one third of programs and safety issues in more than half of the programs. Over half 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; this was the case in only 13% of applications that did not show any major clinical outcome issues.
Likewise, 91% of development programs that had problems in the early development phases also had issues concerning the results of confirmatory studies. Similar issues in the later phase of drug development occurred in only 55% of those applications that did not have problems in the early phases, the authors found.
“The analysis shows differences in the types of issues raised for neurology medicines and psychiatry medicines: issues around the planning of confirmatory studies as well as the clinical relevance of the results were more common in psychiatry than in neurology. These issues were also shown to be among the ones impacting the outcome of the application the most in psychiatry,” noted a statement issued by the EMA on November 29.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/11/news_detail_002654.jsp&mid=WC0b01ac058004d5c1
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.