Placebo Response Mitigation Strategies & Tools for Optimizing Clinical Trials

Life Sciences, Clinical Trials, Pharmaceutical,
  • Monday, October 24, 2022

Whilst placebo effects can be a valuable adjunct in patient care, they can pose a significant threat to clinical trials, and their ability to provide clear, interpretable readouts. Particularly in randomized placebo-controlled trials for central nervous system conditions, high levels of placebo response can lead to failed studies, delayed or abandoned projects and increased costs. Trial sponsors, in addition to staying abreast of the latest science on placebo effects, must evaluate the most relevant mitigation strategies. Above all, they must select approaches that will improve signal detection and assay sensitivity to ensure studies are completed on time, within budget and with maximum opportunity for a successful outcome.

This webinar will review available methods to mitigate the negative impact of the placebo response in clinical trials for therapies for diseases of the central nervous system. The featured speakers will discuss the origin and nature of the placebo response, the advantages and limitations of approaches to address the placebo response in drug development and how complementary solutions offered by Syneos Health® Clinical Surveillance & Training (CST) team and Cognivia® may be used in concert to maximize the benefits to trials.

The speakers will discuss strategies and tools for the management of placebo effects with a view to maximizing the clarity of efficacy signals.

Additionally, material presented will also cover the use of prognostic covariates (Placebell©™ covariates) developed specifically to predict the likelihood of placebo responsiveness of patients participating in a clinical trial. Placebell’s AI-powered algorithm calculates a placebo responsiveness score based on a sophisticated assessment of patient psychology, expectations and other factors. The use of patients’ psychology provides access to a, so far, unreached set of information so critical in phenomena like placebo response. Applying these prognostic covariates significantly decrease the data variability and consequently improves the statistical analysis reducing the risk of trial failure.

Combining the complementary approaches presented in this webinar would position sponsors for higher chances of success in mitigating the impact of the placebo response in clinical trials.

Register to learn about some of the key factors in mediating placebo response in clinical trials, including various mitigation strategies.

Speakers

Dr. Veeraindar Goli, Syneos Health

Dr. Veeraindar Goli, MD, MBA, DLFAPA, Vice President, Medical and Scientific Management, Clinical Solutions, Syneos Health

Dr. Veeraindar Goli has 38 years of experience as a physician in a variety of healthcare environments. Global experience as a physician in Asia, Africa and the United States. He is triple boarded in psychiatry, addiction medicine and pain medicine and is board eligible in geriatric psychiatry. He has well-rounded and deep-rooted experience in small and large pharmaceutical companies, academia, clinical practice and clinical research organizations (CRO). He has an MBA from the prestigious Fuqua School of Business with a special focus on health sector management (HSM) and obtained both degrees from Duke University, Durham, NC. Has a current academic appointment as an Emeritus Professor at Duke University Medical Center where he worked for over 24 years as a Professor in Psychiatry and Assistant Professor in Anesthesiology. In addition, he possesses extensive experience in clinical and developmental aspects of pain medicine and maintains an active medical license in the state of Virginia and North Carolina in the USA.

Dr. Goli has direct experience as a medicine’s development lead, medical monitor, clinician and a principal investigator in all phases of clinical trials. He contributed to IND, NDA submissions, study reports and publications. Dr. Goli made significant contributions to strategic decisions, transition criteria agreements and contributions leading to the approval of NCE’s and reformulations. He had direct experience with the US Food and Drug Administration’s advisory board meeting preparations, PSP’s and clinical holds and launch of approved products. Has been with Syneos Health since 2021.

Message Presenter
Dr. Luke Koschalka, Syneos Health

Dr. Luke Koschalka, PsyD, Sr. Clinical Scientist, Clinical Surveillance & Training (CST), Syneos Health

Dr. Luke Koschalka is a UK-trained clinical psychologist and neuropsychologist. His nearly 15 years in clinical practice saw him work initially with patients with severe and enduring psychiatric diagnoses, both in inpatient and outpatient settings, as well as addiction services. Subsequently, he worked in leadership roles in dementia diagnosis, stroke rehabilitation, acquired brain injury and other areas before moving to Imperial College London, where he led neuropsychological data collection on several large studies. In 2016, he moved to Syneos Health´s Clinical Surveillance & Training team, where he has provided scientific oversight on more than 30 Phase II and III studies, as well as acting more widely as a scientific consultant on study and protocol design.

Message Presenter
Dr. Dominique Demolle, Cognivia

Dr. Dominique Demolle, PhD, CEO, Cognivia

Dr. Dominique Demolle serves as Chief Executive Officer of Cognivia (formerly Tools4Patient) since its inception in 2013. Dr. Demolle holds a PhD in biochemistry from the University of Brussels. She joined the Clinical Research Group of GD Searle and then Eli Lilly. She has held positions with increasing leadership responsibilities at Eli Lilly and Company with the Lilly Indianapolis Clinical Research Unit in the US and the European Operational Staff management and ultimately became the Associate Director of Global Early Phase Operations. In 2007, she co-founded and successfully developed a consulting clinical research organization including partnerships with pharma and biotech before she left to set up Cognivia with previous colleagues. She has contributed to the clinical development of dozens of drugs and several launches.

Message Presenter

Who Should Attend?

Companies and organizations where efficacy data relies on “soft” measures or endpoints completed by subjects including:

  • Pharmaceutical/Biotechnology companies, CROs
  • Tech Companies/Service Providers
  • 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; Clinical Scientists
  • Any Heads or Directors of CNS/Neuroscience programs
  • Companies working in clinical development, especially in indications in CNS/Neuroscience, Pain, Psychiatry, etc.

What You Will Learn

Attendees will gain insights into:

  • How environmental/modifiable factors in clinical trials can be controlled to minimize placebo response
  • How accounting for individual patient psychological traits, expectations, perceptions and beliefs can address interpatient variability in placebo response
  • The advantages of using multiple approaches to address the placebo response that are customized to specific clinical study protocols

Xtalks Partner

Syneos

Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 29,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.

To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com.

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