# Exploring the ethical issues posed by AI and big data technologies in drug development

**Authors:** Yulu Fan, Yancheng Wu, Zitong Wang

PMC · DOI: 10.3389/fpubh.2025.1585180 · 2025-10-20

## TL;DR

This paper examines how AI and big data are transforming drug development and the ethical challenges they introduce.

## Contribution

It systematically analyzes the ethical issues and proposes governance strategies for responsible innovation in AI-driven drug development.

## Key findings

- AI and big data significantly reduce drug development time and costs.
- Ethical concerns include data privacy and algorithmic transparency.
- A responsible innovation ecosystem is needed to address these challenges.

## Abstract

The rapid development and wide application of Artificial Intelligence (AI) and Big Data technologies have profoundly changed the way industries around the world operate, from finance, transportation, education to media, the integration of the two not only improves the efficiency of the industry, but also optimizes the quality of service and decision-making process to a large extent. In the era of deep integration of Biomedicine and AI, AI and Big Data technology are reconstructing the paradigm of drug development with unprecedented intensity. The long cycle of traditional drug development, which takes a decade and billions of dollars in investment, is being compressed to 2 years or even less under the drive of AI. Through big data analytics and deep learning techniques, AI can greatly improve R&D efficiency and accuracy in a variety of aspects such as compound screening, efficacy prediction, and clinical (pre) experiment design. However, the use of AI and big data in drug discovery and development also raises corresponding ethical issues, such as data privacy protection and algorithmic transparency. This article will systematically analyze the technological breakthroughs, potential risks, and governance paths of AI and big data in drug development. It will explore how to strengthen the bottom-line of safety and ethics in the Efficiency Revolution and build a responsible innovation ecosystem.

## Full-text entities

- **Genes:** IL6 (interleukin 6) [NCBI Gene 3569] {aka BSF-2, BSF2, CDF, HGF, HSF, IFN-beta-2}, CYP2F1 (cytochrome P450 family 2 subfamily F member 1) [NCBI Gene 1572] {aka C2F1, CYP2F, CYPIIF1}, TGFB1 (transforming growth factor beta 1) [NCBI Gene 7040] {aka CAEND1, CED, DPD1, IBDIMDE, LAP, TGF-beta1}, UGT1A1 (UDP glucuronosyltransferase family 1 member A1) [NCBI Gene 54658] {aka BILIQTL1, GNT1, HUG-BR1, UDPGT, UDPGT 1-1, UGT1}
- **Diseases:** toxicity (MESH:D064420), cardiovascular (MESH:D002318), R&amp;D (MESH:C580424), interstitial pneumonia (MESH:D017563), deformities (MESH:D009140), obsessive-compulsive disorder (MESH:D009771), kidney damage (MESH:D007674), HIV/AIDS (MESH:D015658), limb deformities (MESH:D017880), liver fibrosis (MESH:D008103), anxiety (MESH:D001007), lung-cancer (MESH:D008175), cancer (MESH:D009369), cholangiocarcinoma (MESH:D018281), acute kidney injury (MESH:D058186), AI (MESH:C538142), long-term toxicity (MESH:D000069451), genetic diseases (MESH:D030342), cardiac toxicity (MESH:D066126)
- **Chemicals:** AZT (MESH:D015215), doxorubicin (MESH:D004317), caffeine (MESH:D002110), irinotecan (MESH:D000077146), thalidomide (MESH:D013792)
- **Species:** Cercopithecidae (monkey, family) [taxon 9527], Macaca mulatta (rhesus macaque, species) [taxon 9544], Homo sapiens (human, species) [taxon 9606], Chlorocebus aethiops (African green monkey, species) [taxon 9534], Rattus norvegicus (brown rat, species) [taxon 10116], Gallus gallus (bantam, species) [taxon 9031], Canis lupus familiaris (dog, subspecies) [taxon 9615], Mus musculus (house mouse, species) [taxon 10090], Macaca (macaque, genus) [taxon 9539], Human immunodeficiency virus 1 (no rank) [taxon 11676]

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Source: https://tomesphere.com/paper/PMC12581208