Conclusive Results: Strategies for Collecting Quality Data in Psychiatric Clinical Trials

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • September 20, 2016

Ensuring that psychiatry clinical trial data accurately captures a compound’s safety and efficacy potential requires an approach that accounts for challenges inherent in working with a mentally ill population. Observing changes in the disease under study is partly a subjective process, and that creates risk of undue influence that the patient and/or investigator may not recognize.

Additionally, not all symptomatic improvement in mental disorders is necessarily attributable to the product under study. Some may result from unrelated factors that produce a therapeutic effect that erodes the efficacy signal of a potential treatment. These are among many issues that, if identified and mitigated early in the development process, can maximize the potential for conclusive study results.

This webinar will examine these factors, with particular focus on:

  • Study design considerations
  • Site factors
  • Subject selection and eligibility
  • Data surveillance

Speakers

Krista Armstrong, PhD, Vice President, Strategic Development, Premier Research

Krista Armstrong, Ph.D., is responsible for the oversight of the Executive Director leadership team for neuroscience, oncology, general medicine, and pediatric and rare diseases portfolios. Dr. Armstrong also serves as the principal strategist who advises, consults, plans and directs the design and strategy of new business opportunities and provides her expertise in the conduct of clinical trials specifically for the neuroscience portfolio.

Dr. Armstrong’s clinical research experience spans over 20 years starting in academia. While pursuing a doctorate degree, she planned and implemented several research projects focused in neurodegenerative pathologies. Areas of interest included both cognition and biochemistry and their relation to memory and motor function deficits in the brain. She was responsible for comprehensive library research, data collection, and animal study for the projects and performed biochemical, histological, and statistical analyses. While in academic research, she worked on industry sponsored studies that generated data to support the approvals and/or continued study of donepezil, tacrine, levodopa, entacapone and interferon beta 1 products.

Dr. Armstrong’s primary therapeutic and operational expertise is within neuroscience with a specific emphasis in the psychiatric indication such as ADHD, schizophrenia, MDD, mania, GAD, OCD, autism, binge eating disorder, addiction, PTSD as well as neurological conditions such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, epilepsy, stroke, spinal device implant, migraine and pain.

In addition to her neuroscience focus, she has a broad range of therapeutic experience including oncology (CML, AML, pancreatic, renal cell, head and neck, prostate, SCLC), cardiovascular (atrial fibrillation, AMI, hypertension), endocrinology (diabetes mellitus, obesity), dermatology (psoriasis, rosacea) and pediatrics (multiple indications including rare diseases) research.

Dr. Armstrong received her Doctorate in Neuroscience from the University of Florida.

Susan Kozauer, MD, Senior Medical Director, Psychiatry, Premier Research

Susan Kozauer, M.D., provides a diverse background in clinical research, private psychiatry practice, and academia. Prior to joining Premier Research in 2016, Dr. Kozauer was Medical Strategy Lead at a major contract research organization, guiding psychiatry proposals that included PK, bioequivalence, Phase II and Phase III, and post-marketing. She advised sponsors on study design and protocol-writing, provided indication-specific medical guidance, and served as medical adviser on more than 25 psychiatry studies.

She spent five years in private psychiatry practice in the Washington, D.C., area, serving adolescent, adult, and geriatric patients. Prior to entering private practice, she was Associate Director of Electroconvulsive Therapy Services at a Washington-area hospital and was Assistant Professor of Psychiatry and Behavioral Sciences at George Washington University Medical Faculty Associates.

Dr. Kozauer holds a Doctor of Medicine degree from the George Washington University School of Medicine and a bachelor’s degree in biology from Cornell University.

Who Should Attend?

VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

  • CNS
  • Neuroscience
  • Clinical Affairs
  • Clinical R&D
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

from pharmaceutical and  biotechnology companies.

Xtalks Partners

Premier Research

Premier Research is a leading CRO serving highly innovative biotech, Pharmaceutical and medical device companies. The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; oncology; and medical devices.

Premier Research and operates in 84 countries. It employs 1,000+ clinical professionals dedicated first and foremost to fulfilling each customer’s requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.

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