Bhatt A. Artificial intelligence in managing clinical trial design and conduct: Man and machine still on the learning curve? Perspect Clin Res. 2021;12:1–3.

Article  Google Scholar 

Ramesh AN, Kambhampati C, Monson JRT, Drew PJ. Artificial intelligence in medicine. Ann R Coll Surg Engl. 2004;86:334–8.

Article  Google Scholar 

Cramer G. Forward Thinking for the Integration of AI into Clinical Trials [Internet]. ACRP. 2023 [cited 2023 Sep 26]. Available from: https://www.acrpnet.org/2023/06/forward-thinking-for-the-integration-of-ai-into-clinical-trials/

A systematic literature review of artificial intelligence in the healthcare sector: Benefits, challenges, methodologies, and functionalities - ScienceDirect [Internet]. [cited 2023 Sep 26]. Available from: https://www.sciencedirect.com/science/article/pii/S2444569X2300029X

Pharmaceuticals | Free Full-Text | The role of AI in drug discovery: challenges, opportunities, and strategies [Internet]. [cited 2023 Sep 26]. Available from: https://www.mdpi.com/1424-8247/16/6/891

Research C for DE and. Artificial Intelligence and Machine Learning (AI/ML) for Drug Development [Internet]. FDA. FDA; 2023 [cited 2023 Oct 2]. Available from: https://www.fda.gov/science-research/science-and-research-special-topics/artificial-intelligence-and-machine-learning-aiml-drug-development

Ethical_Guidelines_AI_Healthcare_2023.pdf [Internet]. [cited 2023 Oct 2]. Available from: https://main.icmr.nic.in/sites/default/files/upload_documents/Ethical_Guidelines_AI_Healthcare_2023.pdf

Artificial Intelligence Applied to clinical trials: opportunities and challenges | SpringerLink [Internet]. [cited 2023 Oct 1]. Available from: https://link.springer.com/article/10.1007/s12553-023-00738-2

Zhong F, Xing J, Li X, Liu X, Fu Z, Xiong Z, et al. Artificial intelligence in drug design. Sci China Life Sci. 2018;61:1191–204.

Article  Google Scholar 

Estimation of clinical trial success rates and related parameters | Biostatistics | Oxford Academic [Internet]. [cited 2023 Oct 18]. Available from: https://academic.oup.com/biostatistics/article/20/2/273/4817524

Calaprice-Whitty D, Galil K, Salloum W, Zariv A, Jimenez B. Improving clinical trial participant prescreening with Artificial Intelligence (AI): A comparison of the results of AI-assisted vs standard methods in 3 oncology trials. Ther Innov Regul Sci. 2020;54:69–74.

Article  Google Scholar 

Bohr A, Memarzadeh K. The rise of artificial intelligence in healthcare applications. Artificial Intelligence in Healthcare. 2020;1(1):25–60. https://doi.org/10.1016/B978-0-12-818438-7.00002-2.

Article  Google Scholar 

Harrer S, Shah P, Antony B, Hu J. Artificial intelligence for clinical trial design. Trends Pharmacol Sci. 2019;40:577–91.

Article  Google Scholar 

Vuksanaj K. AI in Clinical Trials Reality versus Hype [Internet]. GEN - Genetic Engineering and Biotechnology News. 2023 [cited 2023 Oct 1]. Available from: https://www.genengnews.com/topics/artificial-intelligence/ai-in-clinical-trials-reality-versus-hype/

BDCC | Free Full-Text | Artificial intelligence in pharmaceutical and healthcare research [Internet]. [cited 2023 Oct 1]. Available from: https://www.mdpi.com/2504-2289/7/1/10

The Evolution Of Clinical Trials: The Promise Of AI And The Role Of Big Tech [Internet]. [cited 2023 Oct 1]. Available from: https://www.cbinsights.com/research/clinical-trials-ai-tech-disruption/

Jeyaraman M, Balaji S, Jeyaraman N, Yadav S. Unraveling the ethical enigma: artificial intelligence in healthcare. Cureus. 2023;15(8). https://doi.org/10.7759/cureus.43262.

Kolluri S, Lin J, Liu R, Zhang Y, Zhang W. Machine learning and artificial intelligence in pharmaceutical research and development: a review. AAPS J. 2022;24:19.

Article  Google Scholar 

Chan HCS, Shan H, Dahoun T, Vogel H, Yuan S. Advancing drug discovery via artificial intelligence. Trends Pharmacol Sci. 2019;40:592–604.

Article  Google Scholar 

Wang L, Song Y, Wang H, Zhang X, Wang M, He J, et al. Advances of artificial intelligence in anti-cancer drug design: a review of the past decade. Pharmaceuticals. 2023;16:253.

Article  Google Scholar 

Burki T. A new paradigm for drug development. Lancet Digit Health. 2020;2:e226–7.

Article  Google Scholar 

Sarkar C, Das B, Rawat VS, Wahlang JB, Nongpiur A, Tiewsoh I, et al. Artificial intelligence and machine learning technology driven modern drug discovery and development. Int J Mol Sci. 2023;24:2026.

Article  Google Scholar 

Niazi SK. The coming of age of AI/ML in drug discovery, development, clinical testing, and manufacturing: the FDA perspectives. Drug Des Devel Ther. 2023;17:2691–725.

Article  Google Scholar 

Vora LK, Gholap AD, Jetha K, Thakur RRS, Solanki HK, Chavda VP. Artificial intelligence in pharmaceutical technology and drug delivery design. Pharmaceutics. 2023;15:1916.

Article  Google Scholar 

Pharmaceuticals | Free Full-Text | Advances of Artificial Intelligence in Anti-Cancer Drug Design: A Review of the Past Decade [Internet]. [cited 2023 Oct 19]. Available from: https://www.mdpi.com/1424-8247/16/2/253

Selvaraj C, Chandra I, Singh SK. Artificial intelligence and machine learning approaches for drug design: challenges and opportunities for the pharmaceutical industries. Mol Divers. 2022;26:1893–913.

Article  Google Scholar 

Frontiers | Scoping review of the current landscape of AI-based applications in clinical trials [Internet]. [cited 2023 Oct 2]. Available from: https://www.frontiersin.org/articles/10.3389/fpubh.2022.949377/full

Scopus preview - Scopus - Document details - Deep learning [Internet]. [cited 2023 Oct 18]. Available from: https://www.scopus.com/record/display.uri?eid=2-s2.0-84930630277&origin=inward&txGid=4af35adae0520473f8fee302d0db19d8

Liu R, Rizzo S, Whipple S, Pal N, Pineda AL, Lu M, et al. Evaluating eligibility criteria of oncology trials using real-world data and AI. Nature. 2021;592:629–33.

Article  Google Scholar 

Dong J, Geng Y, Lu D, Li B, Tian L, Lin D, et al. Clinical trials for artificial intelligence in cancer diagnosis: a cross-sectional study of registered trials in ClinicalTrials.gov. Front Oncol. 2020;10:1629.

Article  Google Scholar 

Application of Artificial Intelligence Technology in Oncology: Towards the Establishment of Precision Medicine - PMC [Internet]. [cited 2023 Oct 19]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760590/

Region Örebro County. Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project [Internet]. clinicaltrials.gov; 2022 Oct. Report No.: NCT04879563. Available from: https://clinicaltrials.gov/study/NCT04879563

Yousefi S. Clinical applications of artificial intelligence in glaucoma. J Ophthalmic Vis Res. 2023;18:97–112.

Google Scholar 

Application of artificial intelligence in ophthalmology - PMC [Internet]. [cited 2023 Oct 21]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133903/

The application of artificial intelligence in glaucoma diagnosis and prediction - PMC [Internet]. [cited 2023 Oct 21]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10192631/

Artificial Intelligence Algorithms to Diagnose Glaucoma and Detect Glaucoma Progression: Translation to Clinical Practice - PubMed [Internet]. [cited 2023 Oct 21]. Available from: https://pubmed.ncbi.nlm.nih.gov/33117612/

Artificial Intelligence for Glaucoma: Creating and Implementing Artificial Intelligence for Disease Detection and Progression - PubMed [Internet]. [cited 2023 Oct 21]. Available from: https://pubmed.ncbi.nlm.nih.gov/35218987/

Siala H, Wang Y. SHIFTing artificial intelligence to be responsible in healthcare: A systematic review. Soc Sci Med. 2022;296:114782.

Article  Google Scholar 

Stöger K, Schneeberger D, Kieseberg P, Holzinger A. Legal aspects of data cleansing in medical AI. Comput Law Secur Rev. 2021;42:105587.

Article  Google Scholar 

Askin S, Burkhalter D, Calado G, El Dakrouni S. Artificial intelligence applied to clinical trials: opportunities and challenges. Health Technol (Berl). 2023;13:203–13.

Article  Google Scholar 

Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing [Internet]. Federal Register. 2023 [cited 2023 Oct 16]. Available from: https://www.federalregister.gov/documents/2023/04/18/2023-07229/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and

Ethical guidelines for application of Artificial Intelligence in Biomedical Research and Healthcare | Indian Council of Medical Research | Government of India [Internet]. [cited 2023 Oct 16]. Available from: https://main.icmr.nic.in/content/ethical-guidelines-application-artificial-intelligence-biomedical-research-and-healthcare

Health C for D and R. Artificial Intelligence and Machine Learning in Software as a Medical Device. FDA [Internet]. 2023 [cited 2023 Oct 18]; Available from: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

EMA Regulatory Science to 2025 Strategic Reflection. https://www.ema.europa.eu/en/documents/regulatoryprocedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf.

Commissioner O of the. U.S. Food and Drug Administration [Internet]. FDA. FDA; 2023 [cited 2023 Nov 23]. Available from: https://www.fda.gov/

Research C for DE and. Digital Health Technologies (DHTs) for Drug Development. FDA [Internet]. 2023 [cited 2023 Oct 18]; Available from: https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development

Commissioner O of the. Real-World Evidence [Internet]. FDA. FDA; 2023 [cited 2023 Oct 18]. Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

EMA. Reflection paper on the use of artificial intelligence in lifecycle medicines [Internet]. European Medicines Agency. 2023 [cited 2023 Oct 18]. Available from: https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicines

The future of clinical trials and drug development: 2050 - PMC [Internet]. [cited 2023 Oct 18]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10259497/

EMA. Artificial intelligence in medicine regulation [Internet]. European Medicines Agency. 2021 [cited 2023 Oct 18]. Available from: https://www.ema.europa.eu/en/news/artificial-intelligence-medicine-regulation

Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review - PMC [Internet]. [cited 2023 Oct 18]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/

He J, Baxter SL, Xu J, Xu J, Zhou X, Zhang K. The practical implementation of artificial intelligence technologies in medicine. Nat Med. 2019;25:30–6.

Article  Google Scholar 

Privacy Protection in Using Artificial Intelligence for Healthcare: Chinese Regulation in Comparative Perspective - PMC [Internet]. [cited 2023 Oct 18]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9601726/

Salalli R, Dange JR, Dhiman S, Sharma T. Vaccines development in India: advances, regulation, and challenges. Clin Exp Vaccine Res. 2023;12:193–208.

Article  Google Scholar 

Clinical-Trials-in-India.pdf [Internet]. [cited 2023 Oct 19]. Available from: https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/Clinical-Trials-in-India.pdf

Indian Council of Medical Research | Government of India [Internet]. [cited 2023 Nov 23]. Available from: https://main.icmr.nic.in/

Kaur H, Kaur M, Bhattacharyya A, Prajapat M, Thota P, Sarma P, et al. Indian contribution toward biomedical research and development in COVID-19: A systematic review. Indian J Pharmacol. 2021;53:63–72.

Article  Google Scholar 

Guidelines | Indian Council of Medical Research | Government of India [Internet]. [cited 2023 Oct 19]. Available from: https://main.icmr.nic.in/content/guidelines-0

Herring FB Deeona R Gaskin, Josefine Sommer, Atiq Chowdhury, Maria-Oraiozili Koutsoupia, George. EU, U.S., and UK Regulatory Developments on the Use of Artificial Intelligence in the Drug Lifecycle [Internet]. Data Matters Privacy Blog. 2023 [cited 2023 Oct 18]. Available from: https://datamatters.sidley.com/2023/09/06/eu-u-s-and-uk-regulatory-developments-on-the-use-of-artificial-intelligence-in-the-drug-lifecycle/

EMA. Human medicines: regulatory information [Internet]. European Medicines Agency. 2018 [cited 2023 Oct 18]. Available from: https://www.ema.europa.eu/en/human-medicines-regulatory-information

Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008;4:e5.

Article  Google Scholar 

Cascini F, Beccia F, Causio FA, Melnyk A, Zaino A, Ricciardi W. Scoping review of the current landscape of AI-based applications in clinical trials. Front Public Health. 2022;10:949377.

Article  Google Scholar 

Weissler EH, Naumann T, Andersson T, Ranganath R, Elemento O, Luo Y, et al. The role of machine learning in clinical research: transforming the future of evidence generation. Trials. 2021;22:537.

Article  Google Scholar 

Zhou B, Yang G, Shi Z, Ma S. Natural Language Processing for Smart Healthcare. IEEE Rev Biomed Eng. 2022;17:1–17. https://doi.org/10.1109/RBME.2022.3210270.

Article