Project Asha
Collaboration to increase cancer clinical trial access in India
FDA Oncology Center of Excellence (OCE) Project Asha is an initiative in collaboration with the White House Cancer Moonshot Program to increase oncology clinical trial access in India.
In June 2023, President Biden and Prime Minister Modi reaffirmed the strong relationship between the United States and India by announcing new commitments to reduce the burden of cancer in India, including convening a U.S.-India Cancer Dialogue to advance the prevention, early detection, and treatment of cancer.
The goal of this collaboration is to identify short- and long-term opportunities for bilateral cancer cooperation that will drive greater care and improved outcomes for cancer patients.
While India accounts for nearly 20% of the global population, only 1.5% of global trials are conducted in India (The Lancet. Health in India, 2017. Lancet. 2017 Jan 14;389(10065):127. doi: 10.1016/S0140-6736(17)30075-2).
Diverse multiregional global trials participation not only better reflects the racially and ethnically diverse US population, but globalization of research also has immense public health, economic, social, and ethical implications.
Project Asha will focus on the area of clinical trials/research training, a proposed priority identified during the US-India dialogue. This includes:
- Training for early career researchers and pragmatic, patient-centered clinical trials focused on key questions in low-resource setting enabled by Indian pharmaceutical support.
- Identifying collaborative opportunities that promote more inclusive and equitable participation in international cancer research and clinical trials; these collaborations will involve cross-border data transfer, aiming to maximize scientific cooperation while upholding stringent privacy protections.
Project Asha's Aims
- Hold a series of discussions/dialogues with involved stakeholders to outline the current availability of interventional oncology clinical trials, understand the regulatory landscape and identify barriers that exist to bringing intervention oncology clinical trials in India.
- Work closely with Indian regulatory authority as well as Indian government on opportunities to increase access to oncology clinical trials and to share regulatory initiatives and guidance to improve global cancer care.
Short-Term Goals
- Provide training in clinical trial design and conduct to researchers and clinicians in India.
- Provide guidance for regulatory review process in determining benefit: risk analysis for oncology drugs under review.
- Share publicly available review of FDA approved oncology drugs.
- Share published FDA guidance and working with Indian health care professionals and regulators to adapt these to the Indian oncology landscape.
Meet the Team
Project Lead: Geetika Srivastava MD, MSPH
Dr. Srivastava is a hematologist-medical oncologist and medical officer in the Division of Oncology 3, Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA. As a regulatory reviewer she focuses on gastrointestinal malignancies.
Prior to joining FDA in 2022, Dr. Srivastava served as the Oncology Section Chief at Memorial Hospital, University of Colorado in Colorado Springs. Dr. Srivastava received her training at All India Institute of Medical Sciences in New Delhi, India, then received a Master of Epidemiology degree at University of Texas, Houston, and worked as a graduate assistant at MD Anderson Cancer Center. She completed her residency training in Internal Medicine at University of Arkansas, Little Rock, and hematology-medical oncology fellowship at Mayo Clinic, Rochester, MN.
Project Management: Fatima Rizvi, Pharm D, Oncology Center of Excellence