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  1. 2022 OCE Annual Report

Modernizing Evidence Generation

Modernizing Evidence Generation

The OCE supports research and development projects to improve oncology product development for the benefit of people with cancer. This section of the OCE Annual Report highlights projects begun or ramped up in 2022.  

New Projects to Modernize Evidence Generation

Project Beyond Breakthrough 

Following a robust series of external stakeholder engagements in 2022, Project Beyond Breakthrough focused its efforts on internal development of a pilot program focused on early interactions to support dosage strategy selection for previously unapproved oncology products with Breakthrough Designation. Pilot implementation is projected for late 2022, with an accompanying web-based resource in alignment with Project Optimus. 

Project FrontRunner 

Project FrontRunner aims to shift the current oncology drug development paradigm from its typical focus on developing new therapies and gaining accelerated approval in the relapsed and refractory clinical setting, to developing therapies earlier in the clinical course of advanced/metastatic setting.  

In its inaugural year, goals for Project FrontRunner were to conduct outreach and engagement of key stakeholders to assess interest in this approach, and to develop a framework for identifying clinical settings where this approach may be feasible and appropriate. OCE Staff represented Project FrontRunner to multiple audiences including: 

  • Friends of Cancer Research Working Group (August – November 2022 onward) 
  • OCE Mini Symposium “Considerations in Advanced Colorectal Cancer” (October 25) 
  • LUNGevity 2022 Scientific and Clinical Research Roundtable Session (October 26) 
  • Friends of Cancer Research 2022 Annual Meeting Session (November 17) and accompanying White Paper 
  • OCE Mini Symposium “Early Imaging-based Endpoints in Metastatic Prostate Cancer” (December 1) 
  • Articles in the New England Journal of Medicine and The Cancer Letter. 

Project Pragmatica 

Project Pragmatica will explore innovative trial design approaches for approved oncology medical products. Most clinical trials in oncology are extremely complex and take a long time to develop, carry out, and report results. This project will work with  patients, trial investigators, pharmaceutical companies, government agencies, and international healthcare policy stakeholders to evaluate opportunities and challenges in incorporating pragmatic elements into multiregional cancer trials (e.g., more rapid accrual; more heterogeneous population; less attrition, cost, and time). 

Project Site Selector 

Project Site Selector is an initiative to identify trends and rationale for choosing clinical trial sites for participation across all phases of oncology drug development. The impetus for Project Site Selector was based on the recognition that an increasing number of contemporary oncology applications received by FDA, with registrational intent, had either no or very few participants from the U.S.  

Project Site Selector aims to reconcile the impacts of greater ex-US oncology drug development on equitable clinical trial access and generalizability of trial findings to the U.S. population. In July 2022, Project Site Selector held its inaugural public panel discussion entitled Clinical Trial Site Selection: Fact vs Fiction, where members of industry, academia, and patient advocates provided valuable insights on the emerging trends and possible reasoning behind them. In 2023, a further series of workshops and panel discussions are planned to provide a deeper understanding of the site selection process. 


Ongoing Projects to Modernize Evidence Generation


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