US Food and Drug Administration. The evolving role of decentralized clinical trials and digital health technologies. FDA https://www.fda.gov/drugs/news-events-human-drugs/evolving-role-decentralized-clinical-trials-and-digital-health-technologies/ (accessed 25 September 2024).
Shen, R. et al. iinternet versus noninternet participation in a decentralized clinical trial: lessons from the ADAPTABLE study. J. Am. Heart Assoc. 12, e027899 (2023).
Article PubMed PubMed Central Google Scholar
Retzer, A. et al. A toolkit for capturing a representative and equitable sample in health research. Nat. Med. 29, 3259–3267 (2023).
Article CAS PubMed PubMed Central Google Scholar
Adesoye, T., Katz, M. H. G. & Offodile, A. C. 2nd Meeting trial participants where they are: decentralized clinical trials as a patient-centered paradigm for enhancing accrual and diversity in surgical and multidisciplinary trials in oncology. JCO Oncol. Pract. 19, 317–321 (2023).
Nassif, M. et al. Recruitment strategies of a decentralized randomized placebo controlled clinical trial: the canagliflozin impact on health status, quality of life and functional status in heart failure (CHIEF-HF) trial. J. Card. Fail. 29, 863–869 (2023).
Vayena, E., Blasimme, A. & Sugarman, J. Decentralised clinical trials: ethical opportunities and challenges. Lancet Digit. Health 5, e390–e394 (2023).
Article CAS PubMed PubMed Central Google Scholar
Al, M., Levison, S., Berdel, W. E. & Andersen, D. Z. Decentralised elements in clinical trials: recommendations from the european medicines regulatory network. Lancet 401, 1339 (2023).
Article PubMed PubMed Central Google Scholar
Hanley, D. F. Jr. et al. Decentralized clinical trials in the trial innovation network: value, strategies, and lessons learned. J. Clin. Transl. Sci. 7, e170 (2023).
Article PubMed PubMed Central Google Scholar
Inan, O. T. et al. Digitizing clinical trials. NPJ Digit. Med. 3, 101 (2020).
Article CAS PubMed PubMed Central Google Scholar
National Academies of Sciences, Engineering & Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups (The National Academies Press, 2022).
Calvert, M. J. et al. Patient reported outcome assessment must be inclusive and equitable. Nat. Med. 28, 1120–1124 (2022).
Goodson, N. et al. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. NPJ Digit. Med. 5, 58 (2022).
Article PubMed PubMed Central Google Scholar
Aiyegbusi, O. L. et al. Digitally enabled decentralised research: opportunities to improve the efficiency of clinical trials and observational studies. BMJ Evid. Based Med. 28, 328–331 (2023).
de Las Heras, B. et al. Role of decentralized clinical trials in cancer drug development: results from a survey of oncologists and patients. Digit Health 8, 20552076221099997 (2022).
Weber, D. & Nøhr, C. Decentralized clinical trials: potentials for equity in digital health. Stud. Health Technol. Inform. 304, 91–95 (2023).
Dahne, J. & Hawk, L. W. Jr. Health equity and decentralized trials. JAMA 329, 2013–2014 (2023).
Krumholz, H. M. et al. The PAX LC Trial: a decentralized, phase 2, randomized, double-blind study of nirmatrelvir/ritonavir compared with placebo/ritonavir for long COVID. Am. J. Med. S0002-9343, 00271-7 (2024).
Van Norman, G. A. Decentralized clinical trials: the future of medical product development?. JACC Basic Transl. Sci. 6, 384–387 (2021).
Article PubMed PubMed Central Google Scholar
Gill, S. K. et al. Consumer wearable devices for evaluation of heart rate control using digoxin versus beta-blockers: the RATE-AF randomized trial. Nat. Med. 30, 2030–2036 (2024).
Article CAS PubMed PubMed Central Google Scholar
Rosa, C., Marsch, L. A., Winstanley, E. L., Brunner, M. & Campbell, A. N. C. Using digital technologies in clinical trials: current and future applications. Contemp. Clin. Trials 100, 106219 (2021).
Oracle. The accelerated evolution of clinical trials in a pandemic environment. https://go.oracle.com/researchacceleratedtrials?elqCampaignId=257896/ (accessed 25 September 2024).
Cooper, L. & Jose, N. Despite negative perceptions of clinical trial conduct during the coronavirus disease 2019 (COVID-19) pandemic, are decentralized clinical trial methods here to stay? Ann. Transl. Med 11, 159 (2023).
Article PubMed PubMed Central Google Scholar
McDermott, M. M. & Newman, A. B. Remote research and clinical trial integrity during and after the coronavirus pandemic. JAMA 325, 1935–1936 (2021).
Article CAS PubMed Google Scholar
Heads of Medicines Agencies, European Commission & European Medicines Agency. Recommendation paper on decentralised elements in clinical trials. European Commission https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf (13 December 2022).
US Food and Drug Administration. Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials—guidance for industry. FDA https://www.fda.gov/media/157635/download (April 2022).
Dawson, S. et al. Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice. Trials 23, 672 (2022).
Article PubMed PubMed Central Google Scholar
Clinical Trials Transformation Initiative. CTTI recommendations: decentralized clinical trials. https://ctti-clinicaltrials.org/wp-content/uploads/2021/06/CTTI_DCT_Recs.pdf (September 2018).
The Health Research Authority & Medicines & Healthcare products Regulatory Agency. Increasing the diversity of people taking part in research. NHS Health Research Authority https://www.hra.nhs.uk/planning-and-improving-research/best-practice/increasing-diversity-people-taking-part-research/ (accessed 25 September 2024).
Betcheva, L., Kim, J. Y., Erhun, F., Oraiopoulos, N. & Getz, K. Applying systems thinking to inform decentralized clinical trial planning and deployment. Ther. Innov. Regul. Sci. 57, 1081–1098 (2023).
Article PubMed PubMed Central Google Scholar
de Jong, A. J. et al. Opportunities and challenges for decentralized clinical trials: European regulators’ perspective. Clin. Pharmacol. Ther. 112, 344–352 (2022).
Article PubMed PubMed Central Google Scholar
Coran, P. et al. Advancing the use of mobile technologies in clinical trials: recommendations from the clinical trials transformation initiative. Digit Biomark. 3, 145–154 (2019).
Article PubMed PubMed Central Google Scholar
Garcia, A. et al. Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. J. Biopharm. Stat. 32, 496–510 (2022).
Article PubMed PubMed Central Google Scholar
Turakhia, M. P. et al. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: the Apple Heart Study. Am. Heart J. 207, 66–75 (2019).
Perez, M. V. et al. Large-scale assessment of a smartwatch to identify atrial fibrillation. N. Engl. J. Med. 381, 1909–1917 (2019).
Article PubMed PubMed Central Google Scholar
Petrini, C., Mannelli, C., Riva, L., Gainotti, S. & Gussoni, G. Decentralized clinical trials (DCTs): a few ethical considerations. Front. Public Health 10, 1081150 (2022).
Article PubMed PubMed Central Google Scholar
Garjani, A. et al. Decentralised clinical trials in multiple sclerosis research. Mult. Scler. 29, 317–325 (2023).
Park, J., Huh, K. Y., Chung, W. K. & Yu, K. S. The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance. Transl. Clin. Pharm. 32, 41–51 (2024).
Ghadessi, M. et al. Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective. Orphanet J. Rare Dis. 18, 79 (2023).
Article PubMed PubMed Central Google Scholar
Doherty, G. J., Goksu, M. & de Paula, B. H. R. Rethinking cancer clinical trials for COVID-19 and beyond. Nat. Cancer 1, 568–572 (2020).
Article CAS PubMed PubMed Central Google Scholar
Wang, X. et al. Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial. Eur. Heart J. Digit. Health 3, 426–436 (2022).
留言 (0)