The Good Clinical Practice: The Road Ahead in 2025
Year: 2025
Type: article
Abstract: Dear Editor, In 1996, Good clinical practice (GCP) was established for the first time as a framework providing ethical principles to guide the conduct of clinical research aimed at benefiting mankind through the advancement of treatment modalities. Subsequently, these guidelines are adapted globally to meet national requirements for conducting trials. Primarily, GCP inspections are performed to evaluate regulatory compliance and data integrity and protect the rights, safety, and well-being of research participants. A reduction in inspector staff may jeopardize trial results or delay the approval of new therapies.[1] We should take pride in the various advances in conducting clinical trials (CTs), particularly in digital health technology, decentralized CTs, pragmatic adaptive designs, and artificial intelligence (AI), especially regarding the acceleration of study start-up timelines and the recruitment and reporting of CTs. The U.S. Government Accountability Office reported that reduced investigator capacity and a growing number of vacancies continue to increase yearly, climbing from 25 vacancies in November 2021 to 55 in fiscal year (FY) 2022 and 73 in 2023. In FY 2024, the number of unfilled vacancies stands at 51 under the Consolidated Appropriations Act of 2023.[2] Although the United States Food and Drug Administration (FDA) is providing various waivers on submission fees, data, and marketing exclusivities for antibiotics, paediatrics, and orphan diseases to bolster drug development, some GCP violations still occur in CTs. For example, Applied Therapeutics, which works on rare diseases, received a warning letter (24-HFD-45-11-01) citing the deletion of data for 47 patients using Q-global® for critical electronic clinical outcome assessments.[3] After 60 years since the World Medical Association adopted the Declaration of Helsinki (DoH), the latest version was revised in October 2024 with applicable updates for all partners, including principal investigators (PIs), researchers, and organizations involved in the ethical conduct of CTs. Other updates include a specific focus on vulnerable populations, particularly pregnant women, children, and various racial and ethnic minority groups. It also emphasized the critical importance of informed consent for biobanking, confidentiality, environmental sustainability, and the need for rigorous design to minimize waste during trial conduct.[4] The revamped ICH GCP E6 (R3) was adopted on January 6, 2025, highlighting the key activities of trial planning, initiation, performance, recording, oversight, evaluation, analysis, and reporting, as well as quality by design in both data and processes.[5] In 2024, integrating computational technology into the clinical drug development process with AI enhances various stages, including protocol design optimization, screening, collection, evaluation, and reporting of CT results, thereby reducing development costs. In line with this adaptation, the US FDA released draft guidelines on using AI tools in the regulatory decision-making process (level 1). With rapidly advancing treatment and technologies, the newest ICH GCP E6 (R3) and the latest DoH signify a significant amalgamation of scientific and ethical standards in the CTs arena. In conclusion, all these factors may impact the future conduct of CTs by sponsors, PIs, research staff, and the review of marketing authorization applications by regulatory authorities [Figure 1].Figure 1: The role of good clinical practice in clinical trials. AI: Artificial intelligence, DHTs: Digital health technologiesModernized GCP standards prioritize patient-centricity, risk-based monitoring (RBM), and real-world data integration. However, these advances require clinicians to proactively adapt them to maintain ethical rigor and trial validity. The modernized GCP is essential for patient safety, RBM, and real-world evidence integration. In conclusion, clinicians are not just trial implementers; they are guardians of scientific integrity and ethical standards. This role necessitates updated training, advocacy for patient-centered practices, and collaboration with sponsors and ethics committees. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Author: Venu Gopal Jonnalagadda
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4408919735