In India, sponsors of clinical trials have vital responsibilities for the ethical, regulatory, and operational success of sponsored clinical trials. As stated in the New Drugs and Clinical Trial Rules, 2019 – and the Good Clinical Practice (GCP) guidelines issued by the Central Drugs Standard Control Organization (CDSCO), sponsors have accountability for initiator, management, and funding of clinical trials and the quality and integrity of the data. In detail, sponsors’ roles and responsibilities are outlined below, along with a description of how Zenovel, as a Contract Research Organization (CRO), can support sponsors in fulfilling these responsibilities.
Key Responsibilities of Sponsors in Clinical Trials in India
1. Initiation and Management of the Trial
- Protocol Development: Sponsors are tasked with creating a precise, scientifically sound clinical trial protocol that outlines objectives, methodology, design, and analysis plans.
- Selection of Investigators and Sites: Sponsors must choose qualified investigators and trial sites with the necessary expertise and infrastructure for effective trial conduct, ensuring they enter into formal Clinical Trial Agreements.
- Feasibility Assessments: Sponsors conduct feasibility assessments of trial sites to ensure they can meet trial requirements, such as participant recruitment and infrastructure capabilities.
2. Regulatory Compliance
- Ethics Committee ApprovalsSponsors are required to obtain ethical approval from a registered Ethics Committee for regulatory trials and maintain continuous compliance with ethical standards.
- Regulatory Submissions: Sponsors must submit clinical trial applications and amendments to the CDSCO, ensuring compliance with the New Drugs and Clinical Trial Rules, 2019, ICH GCP guidelines, and other relevant regulations.
- Insurance and Indemnity: Sponsors of Clinical Trials of Investigational Medicinal Products (CTIMPs) are required to provide insurance or indemnity to cover potential liabilities.
3. Investigational Product (IP) Management
- Supply and Handling: Sponsors guarantee sufficient supply of Investigational Product at trial sites and ensure the trial team is adequately trained to handle and store it according to the recommended guidelines.
- Manufacturing and Labeling: Sponsors manage the production, packaging, and labeling of the intellectual property (IP) in line with Good Manufacturing Practices (GMP) and local regulatory standards.
4. Quality Management and Monitoring
- Quality Systems: Sponsors must establish quality management systems, ensuring participant safety and data reliability, through risk assessment, monitoring plans, and adherence to Standard Operating Procedures.
- Data Safety Monitoring Board (DSMB): Sponsors establish a DSMB or Independent Data Monitoring Committee (IDMC) to evaluate trial progress, safety data, and critical efficacy endpoints.
- Data Management: Sponsors are accountable for the meticulous collection, storage, and analysis of trial data, ensuring its accuracy, security, and adherence to the statistical analysis plan.
