Project Asha
Collaboration to increase cancer clinical trial access in India
FDA Oncology Center of Excellence (OCE) Project Asha is an initiative to increase oncology clinical trial access in India. 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.
Publications
U.S. FDA analysis of enrollment of Asian patients from India in cancer clinical trials leading to approval from 2010 to 2022 Journal of Clinical Oncology
Outreach/Events/Social Media
Dr. Srivastava at ICMR-PGIMER Workshop of Phase 1 Clinical Trials on Regulatory Aspects
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
Fatima Rizvi, Pharm D is a health scientist in the Oncology Center of Excellence (OCE) at the US Food & Drug Administration (FDA). In this role, she provides regulatory and strategic support for several of the OCE’s initiatives, including the OCE’s Project Asha, Real World Evidence, Project Confirm, Rare Cancers Program and Pediatric Oncology programs.
She received her Bachelor of Science in Psychology and Biology at SUNY Stony Brook and her PharmD from Howard University. Fatima completed her PGY-1 residency at Medstar Washington Hospital Center. Post-residency, she worked as a clinical pharmacist with a focus in internal medicine, ER, transplant, and oncology.
Asha Das, MD
Dr. Das serves as Director of the Division of Clinical Evaluation Oncology in the Center for Biologics Evaluation and Research. Dr. Das earned her bachelor’s and medical degrees from Cornell University. Following internship and residency in internal medicine and neurology at New York-Presbyterian Hospital/Weill Cornell Medicine, she completed fellowship in neuro-oncology at Massachusetts General Hospital. Certified in neurology by the American Board of Psychiatry and Neurology and in the sub-specialty of neuro-oncology by the United Council for Neurologic Subspecialties, Dr. Das has held academic appointments at the University of California, Los Angeles, University of California, San Francisco, and the National University of Singapore. Previously, she was Head of the Neuro-oncology Program at Cedars-Sinai Medical Center. Prior to joining the FDA, Dr. Das held positions of increasing responsibility and leadership at several pharmaceutical and biotechnology companies.
Bindu Kanapuru, MD
Dr. Bindu Kanapuru is a hematologist-oncologist in the Office of Oncologic Diseases (OOD) at the US Food and Drug Administration. Dr. Kanapuru serves as the Associate Director of Therapeutic Review in the Division of Hematologic Malignancies II, that oversees development of therapies for the treatment of multiple myeloma and lymphomas. She joined the FDA in 2015. Her areas of interest include disparities in clinical trials, real world evidence and novel trial designs. Dr. Kanapuru completed her fellowship in hematology and oncology at the University of Maryland Medical Center in Baltimore.
Abhilasha Nair, MD
Dr. Nair is currently Supervisory Associate Director for Safety in the Oncology Center of Excellence (OCE) and Office of Oncologic Diseases in OND/CDER. She received her medical degree from the University of Kerala, India. Following completion of her hematology /oncology fellowship, she completed an advanced oncology drug development fellowship at the National Cancer Institute (NCI) in the early drug development clinic at the NIH clinical center. She joined FDA in 2012, and as Supervisory Associate Director for Safety, she currently oversees the oncology safety team and safety data analytics in OCE. During her FDA career, she has co-authored several manuscripts and served on several key FDA guidance development committees related to pre and post marketing drug safety data and developed a podcast called DISCO that focuses on new drug approvals for the benefit of community oncologists.