The COVID-19 pandemic has had a global impact on nearly every facet of life. Aside from the immediate health emergency and burden to society, SARS-CoV-2, and the resulting coronavirus disease (COVID-19), has directly affected nearly all social, economic and political conventions worldwide. The conduct of clinical research and, by extension, the continuity of drug development has not been immune to the effects of COVID-19. According to a survey published by CenterWatch, 69 percent of responding investigative sites indicated that lockdown measures have impacted their ability to conduct ongoing trials and 78 percent said COVID-19 affected their ability to start new trials.
In response to the pandemic’s impact on clinical trial continuity, the Food and Drug Administration (FDA) acted swiftly with the publication of new guidelines and strategies on how sponsors and investigative sites could adapt to the pandemic while also emphasizing patient safety and trial integrity. While a wealth of information exists on adapting these guidelines into practice, one critical element to the maintenance of clinical trials during the COVID-19 pandemic that has not been adequately addressed is the impact on volunteer interest and motivation to participate in a clinical research trial during a global pandemic.
Given the fragility and uncertainty of clinical trials in the era of COVID-19, many companies have decided to pause or delay activity in multiple different development programs. The long-term impact of delayed new drug approvals will be significant and unavoidable. As resources shift toward new drug therapies for COVID-19 and away from other life-threatening diseases, opportunities for advanced treatment and cures become more obscure. Delays in initiating early Phase 1, first-in-man, safety and tolerability pharmacokinetic (PK) studies, as well as PK studies in special populations with hepatic and renal failure, contribute to the global impact of delayed new drug development. In concert with augmented safety polices, another critical factor that must be considered in maintaining ongoing clinical research continuity is the volunteer’s potential hesitation regarding COVID-19 risk, layered with the inherent risks associated with clinical trial study participation.
In this webinar, participants will learn about:
- A strong COVID-19 risk mitigation plan, which is critical to maintaining interest and participation, and therefore a necessary component for protection of all volunteers but also staff and vendors
- Why limiting the entry of the virus into the research unit should include strict monitoring of business flow and workplace safety measures for staff, volunteers and vendors
- How the spread of the virus at research sites can be greatly reduced through the implementation of workplace controls such as monitored sanitation protocols of common use areas and diagnostic equipment
- Limiting the myths associated with SARS-CoV-2 infection, transmission and associated health risks through comprehensive training and ongoing education of both the volunteer and all staff employed at the research site, including vendors
Dr. Trisha Shamp, Senior Medical Officer, Prism – Nucleus Network
Dr. Trisha Shamp has 20 years of experience in conducting clinical research including comprehensive protocol writing for early phase programs, PK modeling, translational research, renal PK studies and advising biotech on FDA guidance for renal and hepatic PK studies and IND opening protocol creation. She has 15 years of clinical critical care experience, which involved overseeing research in an ICU (highly complex and sick population) She is an advanced cardiac life support instructor, teacher/mentor at medical and pharmacy programs, and advisor to clinical pharmacology online learning platforms. She is proud to serve as a local and global medical missionary and serving anyone hurting/in need. Dr. Trisha Shamp has a PhD Clinical Pharmacology, PA-C (Physician Assistant, NCCPA board certified), is a board-certified Cardiovascular PA-C with American Board of Cardiovascular Medicine, as well as a certified Surgical Physician Assistant with the NCCPA (National Academy of Physician Assistants).Message Presenter
Jeff Cosgrove, VP, USA, Nucleus Network
Jeff Cosgrove is recognized as a leading clinical research executive who has provided both strategic vision and operational leadership across a vast array of therapeutic areas during his 30 years in the clinical research field. From his start at Hennepin County Medical Center, Minneapolis, MN in 1990, through his founding of Prism Research in 2004, Cosgrove’s in-depth understanding and experience across the clinical operations value chain has led to the successful execution of over 800 early phase research protocols.
Cosgrove’s clinical operations experience is sought by sponsors, peers, and employees alike, being published in industry publications and serving as guest faculty lecturer for the University of Minnesota, Masters in Research Program.
As Vice President, USA, Mr. Cosgrove continues to provide guidance and leadership to our highly tenured cross-functional research team and is an invaluable contributor of his comprehensive knowledge of therapeutic clinical research studies throughout Nucleus Network.Message Presenter
Who Should Attend?
Anyone involved in the following sectors:
- Medical and Life Sciences
The webinar will appeal to a range of different functions, including CEO, CMO, CSO, COO, CFO, VP, and Clinical Operations
What You Will Learn
In this webinar, participants will learn about:
- A strong COVID-19 risk mitigation plan, which is critical to maintaining safety, interest and participation
- Why limiting the entry of the virus into the research unit should include strict monitoring
- How the spread of the virus at research sites can be greatly reduced through the implementation of workplace controls
- Limiting the myths associated with SARS-CoV-2 infection, transmission and associated health risks
Nucleus Network is the only multi-site phase I clinical trials provider located in Australia and the USA. We provide high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical companies across the USA, Europe and Asia. Located within cutting-edge health precincts, our cost-effective, accelerated clinical development solutions are supported by advanced technology, clinical excellence and research expertise.