Challenges and Opportunities in Developing Neurologic Therapies - Page 5

Collaboration. Public-private partnerships can increase cooperation and collaboration between industrial and academic experts (Craven, 2011; Steinmetz, 2009) and promote sharing of knowledge to address challenges with recruitment of patients to clinical trials. The National Institute for Neurological Disorders and Stroke (NINDS) has established the National Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) to support increased organization and centralization of the research process (Lancet Neurol, 2012). This program is intended to speed the progress of therapies from the laboratory to the clinical and will focus on phase 2 and biomarker studies (Lancet Neurol, 2012). A network of 25 clinical centers in the US has been established along with a central coordinating center and a central data coordination center. Researchers will benefit from having a centralized institutional review board based at the coordination center. This eliminates the need for institutional review board approvals at each participating institution and reduces costs and time from study design to opening trial enrollment (Lancet Neurol, 2012). Investigators can apply to use the NeuroNEXT infrastructure to overcome barriers associated with lack of experience in conducting clinical studies and limited access to eligible patients (Lancet Neurol, 2012). Initiatives like the National Alzheimer’s Project Act (NAPA) serve to significantly increase the attention and efforts spent to address one of the most demanding challenges that public health systems are facing. Vital knowledge gaps were identified in three main areas by the National Institute on Aging (NIA): modifiable risk factors to prevent cognitive decline, effective pharmacological agents, and validated diagnostic criteria to improve efficacy of CNS treatment (Lancet Neurol, 2012). Summary In neurology, a new model of drug discovery and development is emerging. Advances in gene tic and molecular technology will increase the ability to understand and disrupt disease progression. Such advances may also aid in detecting early onset of disease and evaluating therapies in development. A growing commitment to public-private partnerships and emphasis on rapid dissemination of research findings will result in enhanced research capabilities (Craven, 2011). Enhancing early research efforts will likely speed progression of novel therapeutics to the market, where they can improve quality of care delivered to patients and, ultimately, patient quality of life.