Biopharmaceutical companies developing new CNS products can face special obstacles. According to an article published on National Center for Biotechnology Information, “despite great advances in basic neuroscience knowledge, the improved understanding of brain functioning has not yet led to the introduction of truly novel pharmacological approaches for the treatment of central nervous system disorders. This situation has been partly attributed to the difficulty of predicting efficacy in patients based on results from preclinical studies.” Hence why clinical pharmacology trials for CNS drugs are complex and require in-depth clinical expertise.
DESIGNING AND CONDUCTING TRIALS FOR CNS DRUGS, DOES YOUR CRO HAVE WHAT IT TAKES?
Here are a few elements to consider to gauge whether or not your CRO has what it takes to support the complex nature of CNS drug development.
Expertise —CNS study teams should possess both therapeutic and technical expertise. Issues related to dose selection, dosing intervals, duration of intervention, and safety and efficacy measures, such as cognitive assessments and biomarkers, are important factors to consider. Finally, ensuring that the CRO you choose has an extensive understanding of psychiatric and neurologic disorders can oftentimes be the key to a successful trial.
Understanding of Regulatory Complexities —To satisfy the regulatory need to establish a favorable risk-benefit profile for CNS drugs or to enable a label claim, it is important to work with a CRO that can address issues, such as abuse liability, cognitive and motor impairment, and interactions with other CNS drugs as well as alcohol. Also important is a close working relationship with an IRB which will ensure your CRO understands the CNS study requirements, such as if they require suicidality measures beyond the regulatory expectations, and will guarantee that your protocol is IRB-submission ready. This will minimize the risk of amendments and ultimately shorten study start-up time.
Distinctive Recruitment Strategies — CNS diseases range from depression, Alzheimer’s, ADHD, social phobia, to pain. The ability to recruit the right patient populations is especially important in studies involving CNS-acting drugs due to safety concerns and the potential to look at proof of concept early in development.
Dedicated Research Physicians — The significant involvement of physicians with extensive clinical conduct and research experience is a key element when successfully conducting CNS trials due to the adverse event (AE) profile and safety concerns associated with this drug class. A skilled physician will help to screen the right patients, making dose adjustment decisions and manage AEs and potentially serious adverse events (SAEs).
WANT TO LEARN MORE?
Altasciences is excited to partner with organizations developing CNS drugs. We would welcome the opportunity to share our expertise in the field of early phase clinical conduct and discuss any questions you may have.