Endnotes 1. IQVIA Institute for Human Data Science. (2024, February). Global trends in R&D 2024: Activity, productivity, and enablers. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-trends-in-r-and-d-2024-activity- productivity-and-enablers 2. Mullin, R., & Chemical Engineering News. (2020, November 11). Cost to develop new pharmaceutical drug now exceeds $2.5B. Scientific American. https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now- exceeds-2-5b/ 3. Clinical Leader. (n.d.). Considerations for improving patient recruitment into clinical trials. Retrieved November 1, 2024, from https://www.clinicalleader.com/doc/considerations-for-improving-patient-0001 4. Zaim, N., et al. (2022, July). Decentralized clinical trials: Current status and future prospects. Frontiers in Digital Health, 4(5). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293739/ 5. France, N., & Berrón, C. (2023, February 28). Considerations to reach underrepresented groups. Applied Clinical Trials. https://www.appliedclinicaltrialsonline.com/view/considerations-to-reach-underrepresented-groups 6. McCoubrey, D. (2019). Introduction to the EU regulatory submission timeline. Almac Group. https://www.almacgroup. com/wp-content/uploads/2019/09/Introduction-to-the-EU-regulatory-submission-timeline-David-McCoubrey.pdf 7. Tufts Center for the Study of Drug Development. (2016, January 14). Protocol amendments improve elements of clinical trial feasibility, but at high economic and cycle time cost, according to the Tufts Center for the Study of Drug Development. https://www.globenewswire.com/news-release/2016/01/14/1187511/0/en/Protocol-Amendments- Improve-Elements-of-Clinical-Trial-Feasibility-But-at-High-Economic-and-Cycle-Time-Cost-According-to-the-Tufts- Center-for-the-Study-of-Drug-Development.html 8. Getz, K. (2014, May 12). Improving protocol design feasibility to drive drug development economics and performance. International Journal of Environmental Research and Public Health, 11(5), 5069–5080. https://pmc.ncbi.nlm.nih. gov/articles/PMC4053871/#:~:text=Tufts%20CSDD%20estimates%20that%20the%20total%20cost%20for%20 sponsors%20to 9. Getz, K., et al., Tufts Center for the Study of Drug Development. (2024, May). New benchmarks on protocol amendment practices, trends and their impact on clinical trial performance. Therapeutic Innovation & Regulatory Science, 58(3), 539–548. https://pubmed.ncbi.nlm.nih.gov/38438658/ 10. Baer, A. R., et al. (2011, May). The clinical research team. Journal of Oncology Practice, 7(3), 188–192. https://pmc.ncbi. nlm.nih.gov/articles/PMC3092661/ 11. Reites, J. (2021, August 10). 5 ways that decentralized clinical trial approaches can reduce study costs. MedCity News. https://medcitynews.com/2021/08/5-ways-that-decentralized-clinical-trial-approaches-can-reduce-study-costs/ 12. Pharma.AI. (n.d.). InClinico. Retrieved November 8, 2024, from https://pharma.ai/inclinico 13. Reites, J. (2021, August 10). 5 ways that decentralized clinical trial approaches can reduce study costs. MedCity News. https://medcitynews.com/2021/08/5-ways-that-decentralized-clinical-trial-approaches-can-reduce-study-costs/ 14. The Conference Forum. (2024, September 9). If you build it, they will come: Patient preferences in clinical trial participation. https://theconferenceforum.org/editorial/if-you-build-it-they-will-come-patient-preferences-in-clinical-trial- participation 15. AMGEN. (2022). Follow the data. https://www.amgen.com/stories/2022/10/follow-the-data 16. Hale, C. (2024, June 21). Study shows generative AI can speed up clinical trial enrollment for pennies per patient. Fierce BioTech. https://www.fiercebiotech.com/medtech/study-shows-generative-ai-can-speed-clinical-trial-enrollment-pennies- patient 17. Medidata. (2024, July 25). Essai selects Medidata’s Clinical Data Studio to enhance and modernize clinical trial efficiency and patient experience [Press release]. https://www.medidata.com/en/about-us/news-and-press/eisai-selects- medidatas-clinical-data-studio-to-enhance-and-modernize-clinical-trial-efficiency-and-patient-experience/ 18. Getz, K. (2023, May 1). Shining a light on the inefficiencies in amendment implementation. Applied Clinical Trials. https:// www.appliedclinicaltrialsonline.com/view/shining-a-light-on-the-inefficiencies-in-amendment-implementation 19. Manthra, B., et al. (2024, April 16). EU AI Act: Everything life sciences companies need to know. ZS. https://www.zs.com/ insights/eu-ai-act-everything-life-sciences-companies-need-to-know 20. Goldman, M. (2024, August 12). States are writing their own rules for AI in health care. Axios. https://www.axios. com/2024/08/12/states-regulate-ai-health-care Intelligent Clinical Trials: Using Generative AI to Fast-Track Therapeutic Innovations 18

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