Project Asha: Indo-US physician collaborates with FDA for oncology trials

An Indian-American physician Dr Geetika Srivastava is leading an initiative of the Food and Drug Administration (FDA) in collaboration with the White House Cancer Moonshot Programme which will significantly enhance access to oncology clinical trials in India.

India’s population comprises nearly 20 per cent of the global populace, yet only a mere 1.5 per cent of global trials are conducted within its borders. Project Asha arises as a crucial response to this disparity.

The name of the project is ‘Project Asha’.

The project stems from the landmark Official State visit of Prime Minister Narendra Modi to the US in June 2023, where he and US President Joe Biden committed to alleviating the cancer burden in India.

The two leaders announced a US-India Cancer Dialogue aimed at advancing cancer prevention, early detection, and treatment.

Designed to identify short- and long-term avenues for bilateral cancer cooperation, Project Asha aims to enhance care and outcomes for cancer patients through joint efforts.

The FDA’s Oncology Center of Excellence (OCE) has named Indian American physician Dr. Geetika Srivastava to lead the project.

Dr Srivastava, a hematologist-medical oncologist and medical officer in the FDA’s Division of Oncology 3, Office of Oncologic Diseases, brings a wealth of expertise to this role, particularly in gastrointestinal malignancies.

Prior to her tenure at the FDA starting in 2022, Dr Srivastava served as the Oncology Section Chief at Memorial Hospital, University of Colorado in Colorado Springs.

She received her medical training at the prestigious All India Institute of Medical Sciences in New Delhi before pursuing a Master of Epidemiology degree at the University of Texas, Houston.

Her professional journey also included a stint as a graduate assistant at the renowned MD Anderson Cancer Center, followed by residency training in Internal Medicine at the University of Arkansas, Little Rock, and a hematology-medical oncology fellowship at the Mayo Clinic in Rochester, MN.

The mandate of Project Asha involves conducting dialogues with stakeholders to assess the current landscape of interventional oncology clinical trials in India, navigating regulatory challenges, and pinpointing barriers to trial implementation. Collaborating closely with Indian regulatory authorities and the government, Project Asha seeks to expand access to oncology trials and share regulatory insights to enhance global cancer care standards.

Immediate priorities include training researchers and clinicians in clinical trial design, providing guidance on regulatory reviews for oncology drugs, and fostering diverse participation in global trials.

The project’s focus on clinical trial/research training aligns with the priorities outlined in the US-India dialogue. It emphasises training for early career researchers and the facilitation of patient-centred clinical trials in low-resource settings, supported by Indian pharmaceutical expertise. PTI