Conducting global clinical trials offers several advantages, including diverse patient populations, accelerated application timelines, and cost-effectiveness. But securing domestic regulatory approvals for the use of the resulting data can be complex. The US Food and Drug Administration (FDA), the European Medicines Agency, and the UK Medicines and Healthcare products Regulatory Agency all have similar data standards and expect foreign data to meet similar standards of quality, reliability, and integrity as data generated domestically. But variations in trial design, patient demographics, and regulatory requirements across countries can complicate approval processes. In most jurisdictions, sponsors must demonstrate that the trial data is applicable to the relevant population and complies with the International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice standards. In the United States, pre-submission meetings with the FDA can help clarify expectations and address any concerns regarding the foreign data. Sponsors, CROs, and other clinical trial service providers (collectively “conducting parties”) should meticulously document the conduct of global trials, including protocols, informed consent forms, and adverse event reports. The FDA may require bridging studies to establish the relevance of foreign data to the US population, and validation of data through on-site inspection or other appropriate means. Where an application is based solely on foreign clinical data, the sponsor must also prove that the studies have been performed by clinical investigators “of recognised competence.” Although the FDA has said that if an application fails to meet any of these criteria it will result in the application not being approvable based on the foreign data alone, the Agency has also said that it will be flexible on this policy, depending on the nature of the drug, device, or biologic, and the data being considered.While the FDA has begun to issue guidance on the use of artificial intelligence (AI) in the approval process, its tolerance for AI in the validity of trial data is not yet known. Conducting parties should document and acknowledge the use of AI at each stage of the trial, including if it was used to design the trial. All this information should be included in the description of the data in the application to the FDA. Conducting parties should also track the international regulation of AI, particularly in the jurisdiction where a foreign trial took place. In Europe, clinical trials must also take into account changing legislation on testing, and in vitro diagnostic tests and devices used in trials. Where these tests and devices are not yet certified, the data generated may also be required for the performance evaluation and investigation of these devices so that additional evidence is required on efficacy.Conducting parties should monitor the regulation of data from certain regions. For example, in March 2024, a US Senate committee voted to approve a bill that would prohibit federal agencies from contracting with Chinese biotech companies, including Wuxi AppTec, on national security grounds. The global clinical trials market is projected to reach US$73.2 billion by 2028. Collaboration between legal experts and pharmaceutical stakeholders is essential to streamline the process, secure regulatory approval, and ensure a return on what is always a substantial investment.
Features Desk
Leveraging global clinical trial data: Navigating domestic regulations
