Washington, Dr. Geetika Srivastava, an Indian-American physician, is leading a Food and Drug Administration (FDA) initiative in collaboration with the White House Cancer Moonshot Program that will significantly expand access to oncology clinical trials in India.

India comprises nearly 20 percent of the global population, yet only 1.5 percent of global trials are conducted within its borders. Project Asha emerges as an important response to this inequality.

The name of the project is 'Project Asha'.

The project stems from Prime Minister Narendra Modi's historic official visit to the US in June 2023, where he and US President Joe Biden committed to reducing the burden of cancer in India.

The two leaders announced the US-India Cancer Dialogue aimed at advancing cancer prevention, early detection, and treatment.Designed to identify short-term and long-term pathways for bilateral cancer collaboration, 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 FDA's Oncology Division 3, Office of Oncologic Diseases, brings special expertise in gastrointestinal malignancies in this role.

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

He received medical training at the prestigious All India Institute of Medical Sciences, New Delhi before earning a Master of Epidemiology degree from the University of Texas, Houston.His professional journey also included a stint as a graduate assistant at the renowned MD Anderson Cancer Center, followed by residency training in Interna Medicine at the University of Arkansas, Little Rock, and a Hematology-Medica Oncology fellowship at the Mayo Clinic in Rochester, MN. ,

The mandate of Project ASHA includes conducting dialogues with stakeholders to assess the current landscape of interventional oncology clinical trials in India, address regulatory challenges, and explore barriers to TRIA implementation. Collaborating closely with Indian regulatory authorities and the government, Project ASHA seeks to expand access to oncology trials and share regulatory insights to raise global cancer care standards.

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

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