Project Asha: Expanding Access to Cancer Treatment in India
Geetika Srivastava, an FDA physician, spearheads the 'Project Asha' initiative to boost India's access to oncology clinical trials, aiming to establish the country as a global hub.
Geetika Srivastava, an Indian-American physician trained at AIIMS, is a hematologist-medical oncologist and a medical officer at the US Food and Drug Administration (US FDA). In her role, she oversees the review of cancer drug applications while actively treating cancer patients. Srivastava is at the forefront of the FDA’s initiative, ‘Project Asha,’ which aims to expand access to oncology clinical trials in India. This project, stemming from commitments made during Prime Minister Narendra Modi’s visit to the US, includes initiatives such as convening a US-India Cancer Dialogue to enhance efforts in preventing, detecting early, and treating cancer in India.
Srivastava, representing the US FDA, highlighted the agency's forthcoming engagement with stakeholders to discuss the current landscape of oncology clinical trials, regulatory nuances, and the challenges hindering the introduction of intervention oncology clinical trials in India. She emphasized the FDA's regulatory expertise and intention to collaborate with Indian regulators in international forums to share insights and best practices.
Regarding educational initiatives, she mentioned ongoing dialogues about organizing workshops on regulatory sciences targeted at early career researchers. While refraining from specifying a project timeline, she emphasized the long-term nature of these efforts, expressing a commitment to continuous engagement and collaboration with stakeholders.
She commended the leadership of both nations for recognizing the importance of these endeavors and expressed optimism about the direction set by their inquiries and actions.
How Does Project ASHA Help Indian Patients?
The initiative's primary aim is to establish India as a prominent hub for conducting oncology clinical trials globally. However, achieving this objective necessitates the development of a supportive ecosystem.
Dr. Richard Pazdur's vision, articulated during the US-India cancer dialogue, underpins Project Asha's inception. As Srivastava expressed, taking the lead on Project Asha is a significant opportunity to merge expertise in oncology and public health with first-hand experience gained from training in India.
A robust clinical trial ecosystem would grant India access to multi-regional trials, elevating Indian pharmaceutical standards to international levels. The trial and site selection process will be collaborative among stakeholders and tailored to India's requirements.
Srivastava describes the FDA initiating discussions to gain insights and aims to facilitate collaborative discussions among various stakeholders, including patients with cancer, their caregivers, healthcare professionals, clinical trial sponsors, and Indian regulators. The objective is to gather perspectives on the challenges and barriers within the Indian healthcare system and identify opportunities for improvement.
Srivastava emphasized that they acknowledged the complexity of the situation. Their goal was to gain insights into how they could contribute and facilitate collaboration among all stakeholders to enhance the clinical trial ecosystem in India. It was further pointed out that establishing a robust clinical trial framework requires empowering healthcare professionals to enroll patients in cancer clinical trials effectively.
She noted that for a country to establish a robust clinical trial environment, sponsors like pharmaceutical companies must invest in the necessary infrastructure and capabilities for conducting these trials. Additionally, regulatory authorities are vital in ensuring ethical practices, safety, and compliance with international standards.
Furthermore, Srivastava stressed the importance of patient education and communication in fostering a culture where patients understand the significance of participating in clinical trials. She suggested that focusing on patient education and communication could be pivotal to this endeavor.
