How Eligibility Review Can Enhance Clinical Trial Outcomes

Life Sciences, Clinical Trials, Patient Recruitment & Retention,
  • Monday, June 19, 2023

Clinical trials have a high failure rate, even for those compounds that have demonstrated efficacy in Phase 2 in the target population. CNS trials are associated with some of the highest failure rates and pose unique challenges. Clinical trials in CNS/neuroscience are complex and prone to producing uninterpretable or ambiguous results. This can have grave effects on the development of potentially effective treatments — leading to program delay or cancellation, as well as company failure. Measures that help improve clinical trial outcomes by increasing the likelihood of a clear, interpretable signal and avoiding unnecessary trial failure are therefore of great potential value.

Top reasons for trial failure are the inability to demonstrate efficacy as well as safety issues that arise during the trials. While protocols are carefully designed to enroll the appropriate subject pool, Syneos Health has found that about 10 percent of subjects considered appropriate by sites for trial inclusion, did not meet protocol criteria. The enrollment of unsuitable subjects has the potential to have a significant financial cost to sponsors as well as risk signal detection.

So how can an eligibility review enhance clinical trial outcomes?

Join experts from Syneos Health and Karuna Pharmaceuticals as they discuss their strategy implemented by Syneos Health CST (Clinical Surveillance and Training) to help sites identify suitable subjects, minimize noise, protect study investment and help obtain clearer results.


Dr. Stephen Brannan, Karuna Therapeutics

Dr. Steve Brannan, MD, Chief Medical Officer, Karuna Therapeutics

Dr. Steve Brannan is the current CMO at Karuna Therapeutics. A neuroscience drug development expert, he has held senior positions overseeing both clinical development and medical affairs with more than 15 years of industry experience.

Previously, Dr. Brannan was the Therapeutic Head of Neuroscience at Takeda and Vice President for Clinical Research and Medical Affairs at Forum Pharmaceuticals. Dr. Brannan has been active in the development of multiple important central nervous system treatments including Cymbalta, Exelon Patch, Trintellix and VNS for Treatment Resistant Depression while holding various senior roles at Forum, Takeda, Novartis, Cyberonics and Eli Lilly. His experience includes drug development, registration, medical affairs, launch and lifecycle management in the areas of anxiety, depression, epilepsy, neuropathic pain, schizophrenia, migraine, cognition and Alzheimer’s and Parkinson’s diseases.

Dr. Brannan is a member of several scientific societies and groups, including ACNP, ISCTM (member of both the Scientific and Executive Committees), ISCDD, AARR, IOM Neuroforum and CNS Summit (founding member). Prior to joining the pharmaceutical industry, Dr. Brannan was a faculty member at the University of Texas Health Science Center at San Antonio (UTHSCSA) where he specialized in seeing mood and anxiety disorder patients, ran a clinical research unit and did neuroimaging research at the Research Imaging Center. Dr. Brannan trained in psychiatry at UTHSCSA and holds an MD degree from the University of Texas Health Science Center at Dallas (Southwestern Medical School). He has over 40 publications and routinely gives invited talks and presentations at industry conferences.

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Beth Eisenberg, Syneos Health

Beth Eisenberg, PhD, Director, BU Ops (Scientific Director), Clinical Surveillance & Training (CST) Neurosciences, Syneos Health

Dr. Beth Eisenberg is licensed as a clinical psychologist and possesses 21 years of experience in clinical trials/CROs, as well as 12 years of experience working in diverse clinical settings with families, adults and children. She has worked on Phase I, II, III and IV clinical trials as a Rater and Clinical Research Coordinator (five years), Project and Quality Manager in Safety and Pharmacovigilance (five years), Clinical Scientist (10 years) and currently Scientific Director for CST. Her clinical trial indication experience includes psychiatry, cardiology, oncology and dermatology.

Before, as Director of Behavioral Health, she created and implemented integrative approaches to health management to aid in the prevention and reversal of disease. Her clinical work includes individuals, couples and families, adults and children, in the medical, forensic inpatient and community outpatient settings.

Dr. Eisenberg’s doctoral degree in clinical psychology is from California School of Professional Psychology (CSPP) with completion of two specializations — health psychology and clinical/community psychology. Her therapeutic area experiences include ADHD, psychotic disorders, mood and anxiety disorders, eating disorders and substance abuse.

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Dr. Leslie Moldauer, Syneos Health

Dr. Leslie Moldauer, MD, MBA, Vice President, Medical Director, Syneos Health

Dr. Leslie Moldauer has 35 years of diverse clinical experience as a psychiatrist seeing inpatients and outpatients. She worked on numerous Phase I, II, III and IV clinical trials as a Medical Monitor at clinical research organizations (CROs). These include a range of trials from several large global Phase III protocols to smaller Phase II protocols.

Dr. Moldauer joined Syneos Health in 2017. Her prior experience includes: seven years as a Principal Investigator or Sub Investigator on over 100 clinical trials on depression, anxiety, PTSD, migraine headache, Alzheimer’s disease, mild cognitive dementia, weight loss, smoking cessation and vaccines. She had supervisory responsibilities for investigators on a national level.

Dr. Moldauer holds an MD from the State University of New York, Downstate College of Medicine and an MBA from Colorado State University.

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Zelma Gandy-Don Sing, Syneos Health

Zelma Gandy-Don Sing, PhD, Lead Clinical Scientist, Syneos Health

Dr. Zelma Gandy-Don Sing is a Lead Clinical Scientist with Syneos Health. She completed her doctoral program at the The University of Texas at Austin in clinical psychology with an emphasis in child and family studies. With over 25 years of professional experience, she has worked in a variety of public and private settings conducting clinical research, performing psychological assessments, delivering direct therapeutic interventions, leading mental health program evaluation and providing consultation and technical assistance to programs offering psychological services.

For over a decade at Syneos Health, Dr. Sing has been responsible for supplying primary scientific oversight and therapeutic expertise for a range of neuroscience clinical trials including major depressive disorder, schizophrenia, anxiety disorders, sleep disorders, personality disorders, epilepsy, migraine and Tourette syndrome. During this time, she has completed thousands of eligibility reviews of potential clinical trial subjects.

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Who Should Attend?

Job Titles/Departments:

  • Clinical Scientists
  • CEO, CSO, CMO, CDO, COO VP, SVP, EVP, Sr. Director, Director, etc. of:
  • Clinical development; clinical science; clinical operations; regulatory; clinical project management; business development
  • Heads or Directors of CNS or neuroscience programs at pharmaceuticals/biotech companies
  • Clinical research professionals to whom efficacy data rely on “soft” measures or endpoints completed by subjects


  • Pharmaceutical/biotechnology companies
  • CROs
  • Tech companies/service providers
  • Companies working in clinical development, especially in indications in CNS/neuroscience, pain, psychiatry, etc.

What You Will Learn

Attendees will gain insights into:

  • Defining unsuitable subjects and the impact to clinical trial outcomes
  • The Clinical Surveillance and Training (CST)’s approach to eligibility review: benefits and outcomes
  • How is eligibility review perceived by sites and sponsors?

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