Addressing the 'One and Done' Syndrome in Clinical Trials

Addressing the 'One and Done' Syndrome in Clinical Trials

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Tuesday, January 29

1 pm ET / 10 am PT

How bad is the PI turnover problem?

Principal Investigators (PIs) are one of the key players in the clinical trial efficiency equation. They are ultimately responsible for the conduct of the trial at the investigative site. Achieving operational efficiencies at the investigative site is pivotal in the efforts to control costs and ensure successful clinical trials. Unfortunately, the pharmaceutical industry is experiencing a shortage of experienced PIs. The data overwhelming suggests that many PIs choose not to continue with clinical trial research.

As PIs have a huge impact on the success and efficiency of a study, sponsors and CROs are hesitant to use inexperienced PIs to oversee a study site. Lack of experienced PIs can contribute to inefficiencies in site selection, qualification, training, and startup that result in cost increases for sponsors and CROs.

So why is there such a high turnover rate of PIs? And why are the numbers of young physicians entering the field declining? Is clinical trial design complexity behind this high turnover rate? And more importantly, how can we stem this tile?

In this webinar, we will explore:

  • PI turnover: A multifaceted problem. Is it just an issue of adequate compensation?
  • What are the consequences of PI turnover?
  • The importance of training for PIs in establishing what they can expect and how they can grow in their careers
  • The role technology can play in improving communication and transparency at sites and how this can aid sites engaged in studies when PI turnover occurs

This webinar is applicable to:

  • Investigative sites engaged or wishing to engage in clinical studies
  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for project management of studies and operational excellence

Presenters:

Jim Kremidas
Jim is currently the Executive Director for ACRP, a not-for profit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two different large CROs for over 6 years where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company.

Jim is on the advisory board of CISCRP (a non-profit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the NIH. Jim is a frequent presenter at Industry Conferences and his articles/papers have been published in a wide variety of trade journals.
JIM KREMIDAS
Executive Director
Association of Clinical Research Professionals
Joan is the Vice President of Marketing and Strategy at ClinX, a global service solutions provider for research sites, patients and healthcare organizations. Prior to joining ClinX, Joan's 20+ years in the health life sciences industry includes working in senior management roles at SCORR Marketing, CenterWatch, Cambridge Healthtech Institute, Tufts Center for the Study of Drug Development at Tufts University, and PAREXEL International. Joan holds a B.S. in Marketing.

Joan is on the Board of Directors for Greater Gift, The Center for Information and Study on Clinical Research Participation (CISCRP), the US PharmaTimes Steering Committee for CROY, Steering Committee for Pharma Intelligence/Informa Clinical & Research Excellence Awards, Steering Committee for PopUp Star and is an active member of the Association of Clinical Research Professionals (ACRP) and the Drug Information Association (DIA).
JOAN CHAMBERS
VP Marketing and Strategy
ClinX, parent company of ClinEdge
Joan Chambers
Elvin Thalund
Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in goBalto’s effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.
ELVIN THALUND
Director, Industry Strategy
Oracle Health Sciences

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