Novel Therapies for Treating Cervical Cancer in Peru (2022-2023)

Background

Globally, more and more people are being diagnosed with and dying from cancer every year, particularly in low- and middle-income countries (LMICs). The World Health Organization predicts that the number of global cancer deaths will double by 2040 if the current situation is maintained.

Surgery remains the cornerstone treatment for cancer. However, five billion people lack access to basic surgical care. Additionally, while new therapeutic strategies are rapidly emerging in high-income countries, the growing cost of care amplifies existing disparities. There is an urgent need for new therapies that can be implemented within the resource constraints of LMICs.

Project Description

Duke researchers have demonstrated the safety and efficacy of a point-of-care ethanol ethyl cellulose (PEEC) therapy, which can be used as an alternative to surgery in some clinical situations. This project team aims to translate this therapy into the clinic for treatment of cervical cancer. Specifically, the team will focus on objectives that will ensure successful clinical translation of PEEC in Peru, the first launch country for this novel therapy. 

Team members will pursue activities in three subteams. The first subteam will perform a needs assessment to understand the shortcomings of traditional cervical cancer therapies in LMICs like Peru. A deep dive will be performed to see how cervical cancer is currently screened for, diagnosed and treated in LMICs. Once the gaps have been identified, the team will investigate how PEEC could fill these gaps. This will include assessment of the types of resources that are available, what different types of procedures different healthcare workers can perform from a training and healthcare policy perspective, and what would be acceptable to patients. 

The second subteam will collect and analyze data about LMIC health care systems. Students will collect data from publications and public registries to inform how PEEC can be integrated successfully into LMICs, with an initial focus on Peru.

The third subteam will identify and navigate the appropriate regulatory pathways to generate clinical evidence of PEEC safety and efficacy. Team members will acquire data about similar therapeutic technologies that have been previously approved in this space to investigate the best regulatory pathway for implementation and approval of PEEC. They will also generate data about the regulatory landscape of Peru and translation of technologies and therapies from the United States. 

Anticipated Outputs

Needs assessment for cervical cancer treatment in LMICs; pathway for regulatory approvals in the U.S. and Peru; new service delivery model for cervical cancer treatment in LMICs; peer-reviewed publications

Student Opportunities

Ideally, this project team will be comprised of 3 graduate students and 6 undergraduate students. Interested students will likely be from science, engineering, medicine, public policy and global health backgrounds.

Students will develop skills in data generation and analysis, scientific writing, statistical analysis, oral presentations, cultivating partnerships, business acumen, clinical trial design and regulatory pathway navigation. In addition, students may contribute to journal publications. If permitted, selected students will travel to Peru to visit facilities, meet with key stakeholders, collect data about different levels of facilities and meet with regulatory agencies.

Graduate students will serve as subteam leads, building team management skills and project management experience.

Students will work in three subteams. All students will have exposure to each aspect of the project, while specializing in a particular area. Teams will meet collectively and individually once per week. In Fall 2022, the team will meet on Tuesdays from 4:00-5:00 p.m.

Erika Chelales will serve as the project manager.

Selected students will have the opportunity to travel to Lima, Peru, during Spring Break 2023 or Summer 2023.

Timing

Summer 2022 – Summer 2023

  • Summer 2022 (optional): Complete training modules such as responsible conduct of research, other human subjects research and general laboratory safety
  • Fall 2022: Conduct literature reviews; identify key stakeholders and early adopters; identify market sizes; generate integration data at country, health system and patient/provider levels; interview regulatory experts about federal regulatory pathways; identify appropriate FDA application type; interview physician experts about potential first applications; identify appropriate application
  • Spring 2023: Conduct stakeholder and regulatory engagement in Peru (or in summer); analyze PEEC integration data; develop a launch and marketing strategy; draft appropriate regulatory approval plan
  • Summer 2023 (optional): Conduct stakeholder and regulatory engagement in Peru (if not done over spring break)

Crediting

Academic credit available for fall and spring semesters; summer funding available

 

Image: Vistas de Lima, Peru, by Mariano Mantel, licensed under CC BY-NC 2.0

View of Lima, Peru.

Team Leaders

  • Brian Crouch, Pratt School of Engineering-Biomedical Engineering

/graduate Team Members

  • Erika Chelales, Biomedical Engineering-PHD

/yfaculty/staff Team Members

  • Megan Huchko, School of Medicine-Obstetrics and Gynecology

/zcommunity Team Members

  • Universidad Peruana Cayetano Heredia
  • HopeHPV

Theme(s):