Breakout Session II

Breakout Session Options:

  • Removing Financial Toxicity from Oncology Clinical Trials through Patient Reimbursement Programs
  • Bioethics & Involving Patients Earlier
  • Early Phase Oncology: Conducting Phase 1 Trials
  • Innovative Methods for Oncology Patient Recruitment & Retention in Oncology Research
  • Quality Focus: Does Your QMS Need a Refresh?
  • Site Perspective: Managing the Life Cycle of Clinical Trials
  • Completion of DSAT and the Relationship Specific to Oncology

 


Removing Financial Toxicity from Oncology Clinical Trials through Patient Reimbursement Programs
Less than five percent of eligible patients participate in oncology clinical trials, and out-of-pocket costs and travel logistics are frequently named as a top barrier to enrollment. This number shrinks even further among low-income patients who lack the financial resources to travel to trial sites, and who cannot afford time off from work.  Sites are confronted by significant recruitment challenges; surprisingly 10% of sites fail to enroll a single patient. As a result, studies are delayed, costs go up and new treatments take longer to become available to those who desperately need them.

Facilitator:
Dave Espenshade, Vice President, CRO Partnerships, Greenphire

Panelists:
Gwen Welty MBA, Head, Global Early Phase Development- Site Alliances, Parexel
Dan Milam, EMBA,
Director, Clinical Trial Partnerships, EQRx
Melanie Flores, 
VP, Operations, Advarra

 


Bioethics & Involving Patients Earlier
By understanding the ethical, social, and legal issues that arise in biomedicine and biomedical research, or bioethics, we can gain a better perspective on how to engage and recruit our patients. In this session, we will discuss how bioethics will play a role in the future of oncology clinical research.

Facilitator:
Wendy Tate, PhD, MS, GStat
, Director, Advanced Analytics and Research Optimization,  Advarra

Panelists:
April Coburn, MA, Associate Director of Scientific Affairs – Site Activation Liaison, ICON
Susan Night, JD, LLM, 
Vice President, Site Engagement and Network Development, TD2
Lindsay McIntire, CCRC, 
Director of Clinical Project Management, Javara

 


Early Phase Oncology: Conducting Phase 1 Trials
Are you interested in conducting phase I oncology trials, or are you already? Come discuss the unique trial dynamics and how to avoid some common pitfalls and what makes phase I oncology trials different. Learn what sponsors, CROs and sites are looking for in phase I oncology trials and discuss some lessons learned on site engagement, selection, startup and conduct.

Facilitator:
Renee Smith MBA, Head Early Development Capabilities and Alliances, Janssen

Panelists:
Peter Fredette, Strategic Site Networks Director, IQVIA
Betsy Henk, Director of Quality and Compliance, US Oncology Research
Angela Fritsche, MPA, Operations Administrator, Mayo Clinic Cancer Center

 


Innovative Methods for Oncology Patient Recruitment & Retention in Oncology Research
There is no shortage of questions when it comes to oncology clinical trial referral and recruitment. Is “fear of losing the patient” validated? Am I capturing the right referral chains for my portfolio? Is there a role for patient advocacy groups? What is the role in oncology trial recruitment for advanced practice providers? Hear answers to common questions as well as successful experiences and best practices in building and expanding patient referral networks.

Facilitator:
Malia Lewin, JD, Global Head of Strategy, Teckro

Panelists:
Felicia Irvin MBA, ACRP-CP, Senior Director of Business Development, IACT Health
Hillary A. King, Director of Clinical Site Operations, Pfizer

 


Quality Focus: Does Your QMS Need a Refresh?
A Quality Management System (QMS) helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and provide a model for continuous improvement. How’s your site’s QMS? Revisions may be needed with recent changes in site workflows, new technology implementations, and changes in monitoring. An effective QMS can even reduce site burden (e.g. less queries). Is it time to update your QMS?

Facilitator:
Karri Venn, RD, CDE, CCRC, COO, President, Chair of Operating Board, Centricity Research

Panelist:
Trevor Cole, BHS, MBA-HCM-PM, CCRC,
Sr. Manager, Client Delivery, WCG Avoca

 


Site Perspective: Managing the Life Cycle of Clinical Trials
During 2021, Mary Crowley Center Research conducted two trial portfolio reviews. In this session, Jennifer Hunter, Director of Research Operations, Mary Crowley Cancer Research will speak to the analysis, the outcomes (such as number of trials closed and acuity thresholds), and the impact on resources. Mary Crowley Cancer Research representatives will share their struggles and successes and engage other sites to discuss how they manage their trial portfolio and resources.

Panelists:
Jennifer Hunter CCRP, Director of Research Operations, Mary Crowley Cancer Research
Tina Nghiem, Associate Director, Clinical Trial Development, Mary Crowley Cancer Research

 


Completion of the DSAT and the Relationship Specific to Oncology

The Diversity Site Assessment Tool (DSAT) is becoming a gold standard for developing a benchmark understanding of the needs of sites in training and education related to diversity enrollment.  The DSAT will be explained and completed in this session, and data will be shared as to the unique elements of how this tool relates specifically to the area of oncology.

Speaker:
Diana Foster, PhD, Vice President, Strategy and Special Projects, SCRS
Melynda Geurts, MS, 
Senior Vice President, CRO Services, Total Diversity

 

Location: See App for Room Location Date: May 21, 2022 Time: 1:00 pm - 2:00 pm
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