• Understanding the importance of providing a DCT for oncology
• Using DCT approaches to improve trial outcomes and data quality
• Considering the additional requirements when conducting an expanded access program for gene therapies

Speaker:

Esther Howard
Oncology Advisor
THREAD

An overview of findings from original research conducted by Tufts CSDD looking at the innovation cycle for technologies and tools supporting virtual clinical trials will be presented discussed; innovation adoption cycle times by company size and type will be described and discussed; study results on perceived cycle optimization opportunities, as well as challenges to wide-spread adoption of technologies and tools supporting virtual clinical trials will be presented; practical implications of this research will be discussed: the session will close with Q&A.

Speaker:

Maria I. Florez, MA
Research Consultant; Tufts Canter for the Study of Drug Development
Tufts University School of Medicine

• What does it mean to decentralize your trial?
• How to design a study with decentralized visits in mind
  • Procedures and populations that fit the decentralized visit model
  • Considering the patient perspective
• Lessons learned from mid-pandemic implementation

Speaker:

Shelby Stillwagon
Senior Director, Decentralized Clinical Trials
ProPharma Group

• New multi-stakeholder recommendations and best practices for effectively incorporating decentralized elements into clinical trials from the earliest stages of trial design;
• Identify current challenges to operationalizing decentralized elements and resources available,
• Opportunities to address these challenges in individual trials and programs, as well as through continued multi-stakeholder collaboration.

Speakers:

Megan K. Doyle
Global Regulatory and R&D Policy Lead, Combination Products, Digital Health, and Diagnostics
Amgen, USA 

Some advances are innovative and some just do things the old, inefficient way online. There are four tests you can use to determine if a technology or approach you are adopting in your studies is truly innovative. As we enter troubled economic waters, now is the time to improve efficiency and drive ROI in clinical research.

• Explore an actionable definition of innovation in the context of clinical research
• Importance of human performance to study success cannot be overlooked, we need performance management technology. Exploration of the risks associated with traditional training and the learning management system approach vs. emerging technologies in adult learning.
• Data from pivotal studies will be presented to demonstrate the scope of the opportunity to drive efficiency.

Speaker:

David Hadden
President & Founder
Pro-ficiency

• Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a survey in early 2021 to investigate racial and ethnic disparities in healthcare professionals’ (e.g., doctors, nurses, physician assistants, and other allied-health professionals) perceptions of clinical research and barriers to professional involvement.
• This talk will discuss the results of survey analysis and implications for healthcare professionals (HCPs), investigative sites, and industry.
• Findings will focus on the impact of mentorship and professional networks on access to clinical trials.
• Disparities in willingness to refer patients to clinical trials and barriers to patient referral will be addressed.
• The discussion will also touch on other topics relating to HCP involvement in clinical research and their relationship to racial and ethnic disparities in the clinical research workforce, including previous exposure, awareness, and sponsor recruitment, among others.

Speaker:

Emily Botto
Research Analyst, Tufts Center for the Study of Drug Development
Tufts University School of Medicine, USA