{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T21:49:23Z","timestamp":1792014563978,"version":"4.4.0"},"reference-count":38,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T00:00:00Z","timestamp":1791936000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T00:00:00Z","timestamp":1791936000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["npj Health Syst."],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Remote patient monitoring (RPM) is becoming increasingly feasible to implement in clinical trials. A framework is presented for developing RPM digital solutions incorporating the needs and perspectives of patients and healthcare professionals, and regulatory requirements\/guidance. This framework is illustrated with recent examples of RPM deployments in the context of skin toxicities and stomatitis. Strategies to overcome challenges in the adoption of RPM solutions in clinical trials are discussed.<\/jats:p>","DOI":"10.1038\/s44401-026-00161-5","type":"journal-article","created":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T21:10:57Z","timestamp":1792012257000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Digital transformation of clinical trials with remote patient monitoring solutions"],"prefix":"10.1038","volume":"3","author":[{"given":"Elisabeth","family":"Piault","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramya","family":"Palacholla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Pulman-Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmett Alton","family":"Sartor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7226-6305","authenticated-orcid":false,"given":"Sergio","family":"Sim\u00f3n","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill","family":"Bell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,14]]},"reference":[{"key":"161_CR1","doi-asserted-by":"publisher","first-page":"808","DOI":"10.1093\/eurjcn\/zvae158","volume":"24","author":"L Klompstra","year":"2025","unstructured":"Klompstra, L., Stromberg, A., Jaarsma, T. & Hendriks, J. M. Challenges and strategies for effective recruitment and retention of participants in clinical research studies. Eur. J. Cardiovasc. Nurs. 24, 808\u2013812 https:\/\/doi.org\/10.1093\/eurjcn\/zvae158 (2025).","journal-title":"Eur. J. Cardiovasc. Nurs."},{"key":"161_CR2","doi-asserted-by":"publisher","first-page":"1041","DOI":"10.1001\/jamaoncol.2023.1648","volume":"9","author":"SL Hillman","year":"2023","unstructured":"Hillman, S. L. et al. Rates of and factors associated with patient withdrawal of consent in cancer clinical trials. JAMA Oncol. 9, 1041\u20131047 https:\/\/doi.org\/10.1001\/jamaoncol.2023.1648 (2023).","journal-title":"JAMA Oncol."},{"key":"161_CR3","doi-asserted-by":"publisher","first-page":"287","DOI":"10.1016\/j.cct.2006.02.001","volume":"27","author":"MA Kendall","year":"2006","unstructured":"Kendall, M. A., Andersen, J. W. & van der Horst, C. A reduced frequency visit schedule underreports adverse events that resulted in dose modifications or treatment discontinuations in HIV\/AIDS clinical trials: ACTG DACS 207. Contemp. Clin. Trials 27, 287\u2013294 https:\/\/doi.org\/10.1016\/j.cct.2006.02.001 (2006).","journal-title":"Contemp. Clin. Trials"},{"key":"161_CR4","doi-asserted-by":"publisher","first-page":"168","DOI":"10.1177\/1740774520972125","volume":"18","author":"F Kennedy","year":"2021","unstructured":"Kennedy, F. et al. Online monitoring of patient self-reported adverse events in early phase clinical trials: views from patients, clinicians, and trial staff. Clin. Trials 18, 168\u2013179 https:\/\/doi.org\/10.1177\/1740774520972125 (2021).","journal-title":"Clin. Trials"},{"key":"161_CR5","doi-asserted-by":"publisher","first-page":"929","DOI":"10.1185\/03007990902774765","volume":"25","author":"DE Stull","year":"2009","unstructured":"Stull, D. E., Leidy, N. K., Parasuraman, B. & Chassany, O. Optimal recall periods for patient-reported outcomes: challenges and potential solutions. Curr. Med. Res. Opin. 25, 929\u2013942 https:\/\/doi.org\/10.1185\/03007990902774765 (2009).","journal-title":"Curr. Med. Res. Opin."},{"key":"161_CR6","doi-asserted-by":"publisher","first-page":"e246228","DOI":"10.1001\/jamanetworkopen.2024.6228","volume":"7","author":"B Daly","year":"2024","unstructured":"Daly, B. et al. Remote monitoring and data collection for decentralized clinical trials. JAMA Netw. Open 7, e246228 https:\/\/doi.org\/10.1001\/jamanetworkopen.2024.6228 (2024).","journal-title":"JAMA Netw. Open"},{"key":"161_CR7","unstructured":"US Food and Drug Administration. Conducting clinical trials with decentralized elements: guidance for industry, investigators, and other interested parties, 1\u201318 https:\/\/www.fda.gov\/media\/167696\/download (2025)."},{"key":"161_CR8","doi-asserted-by":"publisher","first-page":"408","DOI":"10.1038\/s41746-025-01811-y","volume":"8","author":"Y Jiang","year":"2025","unstructured":"Jiang, Y. et al. Understanding the gap between expectations and reality in decentralized clinical trials. npj Digit. Med. 8, 408 https:\/\/doi.org\/10.1038\/s41746-025-01811-y (2025).","journal-title":"npj Digit. Med."},{"key":"161_CR9","doi-asserted-by":"publisher","first-page":"43","DOI":"10.2337\/dsi21-0015","volume":"35","author":"EL Johnson","year":"2022","unstructured":"Johnson, E. L. & Miller, E. Remote patient monitoring in diabetes: how to acquire, manage, and use all of the data. Diab. Spectr. 35, 43\u201356 https:\/\/doi.org\/10.2337\/dsi21-0015 (2022).","journal-title":"Diab. Spectr."},{"key":"161_CR10","doi-asserted-by":"publisher","first-page":"e70422","DOI":"10.2196\/70422","volume":"27","author":"MM Paul","year":"2025","unstructured":"Paul, M. M. et al. The state of remote patient monitoring for chronic disease management in the United States. J. Med. Internet Res. 27, e70422 https:\/\/doi.org\/10.2196\/70422 (2025).","journal-title":"J. Med. Internet Res."},{"key":"161_CR11","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1089\/tmj.2016.0051","volume":"23","author":"A Vegesna","year":"2017","unstructured":"Vegesna, A., Tran, M., Angelaccio, M. & Arcona, S. Remote patient monitoring via non-invasive digital technologies: a systematic review. Telemed. e-Health 23, 3\u201317 https:\/\/doi.org\/10.1089\/tmj.2016.0051 (2017).","journal-title":"Telemed. e-Health"},{"key":"161_CR12","doi-asserted-by":"publisher","first-page":"674","DOI":"10.1016\/j.ijmedinf.2012.06.003","volume":"81","author":"JP Chau","year":"2012","unstructured":"Chau, J. P. et al. A feasibility study to investigate the acceptability and potential effectiveness of a telecare service for older people with chronic obstructive pulmonary disease. Int. J. Med. Inform. 81, 674\u2013682 https:\/\/doi.org\/10.1016\/j.ijmedinf.2012.06.003 (2012).","journal-title":"Int. J. Med. Inform."},{"key":"161_CR13","doi-asserted-by":"publisher","first-page":"1179","DOI":"10.1089\/tmj.2022.0299","volume":"29","author":"JA Thompson","year":"2023","unstructured":"Thompson, J. A., Hersch, D., Miner, M. H., Melnik, T. E. & Adam, P. Remote patient monitoring for COVID-19: a retrospective study on health care utilization. Telemed. e-Health 29, 1179\u20131185 https:\/\/doi.org\/10.1089\/tmj.2022.0299 (2023).","journal-title":"Telemed. e-Health"},{"key":"161_CR14","doi-asserted-by":"publisher","first-page":"221","DOI":"10.2147\/PPA.S28889","volume":"6","author":"J Wang","year":"2012","unstructured":"Wang, J. et al. Effect of adherence to self-monitoring of diet and physical activity on weight loss in a technology-supported behavioral intervention. Patient Prefer. Adherence 6, 221\u2013226 https:\/\/doi.org\/10.2147\/PPA.S28889 (2012).","journal-title":"Patient Prefer. Adherence"},{"key":"161_CR15","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1186\/s12872-023-03486-3","volume":"23","author":"A Creber","year":"2023","unstructured":"Creber, A. et al. Use of telemonitoring in patient self-management of chronic disease: a qualitative meta-synthesis. BMC Cardiovasc. Disord. 23, 469 https:\/\/doi.org\/10.1186\/s12872-023-03486-3 (2023).","journal-title":"BMC Cardiovasc. Disord."},{"key":"161_CR16","doi-asserted-by":"publisher","DOI":"10.3389\/fdgth.2022.1052408","volume":"4","author":"JD Coffey","year":"2022","unstructured":"Coffey, J. D. et al. Development and implementation of a nurse-based remote patient monitoring program for ambulatory disease management. Front. Digit. Health 4, 1052408 https:\/\/doi.org\/10.3389\/fdgth.2022.1052408 (2022).","journal-title":"Front. Digit. Health"},{"key":"161_CR17","doi-asserted-by":"publisher","first-page":"e040232","DOI":"10.1136\/bmjopen-2020-040232","volume":"11","author":"ML Taylor","year":"2021","unstructured":"Taylor, M. L., Thomas, E. E., Snoswell, C. L., Smith, A. C. & Caffery, L. J. Does remote patient monitoring reduce acute care use? A systematic review. BMJ Open 11, e040232 https:\/\/doi.org\/10.1136\/bmjopen-2020-040232 (2021).","journal-title":"BMJ Open"},{"key":"161_CR18","doi-asserted-by":"publisher","first-page":"557","DOI":"10.1200\/JCO.2015.63.0830","volume":"34","author":"E Basch","year":"2016","unstructured":"Basch, E. et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J. Clin. Oncol. 34, 557\u2013565 https:\/\/doi.org\/10.1200\/JCO.2015.63.0830 (2016).","journal-title":"J. Clin. Oncol."},{"key":"161_CR19","doi-asserted-by":"publisher","first-page":"197","DOI":"10.1001\/jama.2017.7156","volume":"318","author":"E Basch","year":"2017","unstructured":"Basch, E. et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 318, 197\u2013198 https:\/\/doi.org\/10.1001\/jama.2017.7156 (2017).","journal-title":"JAMA"},{"key":"161_CR20","doi-asserted-by":"publisher","first-page":"2413","DOI":"10.1001\/jama.2022.9265","volume":"327","author":"E Basch","year":"2022","unstructured":"Basch, E. et al. Effect of electronic symptom monitoring on patient-reported outcomes among patients with metastatic cancer: a randomized clinical trial. JAMA 327, 2413\u20132422 https:\/\/doi.org\/10.1001\/jama.2022.9265 (2022).","journal-title":"JAMA"},{"key":"161_CR21","doi-asserted-by":"publisher","first-page":"2693","DOI":"10.1038\/s41591-023-02489-z","volume":"29","author":"CO Duran","year":"2023","unstructured":"Duran, C. O. et al. Implementation of digital health technology in clinical trials: the 6R framework. Nat. Med. 29, 2693\u20132697 https:\/\/doi.org\/10.1038\/s41591-023-02489-z (2023).","journal-title":"Nat. Med."},{"key":"161_CR22","doi-asserted-by":"publisher","first-page":"356","DOI":"10.1093\/oncolo\/oyad237","volume":"29","author":"MRL Lichtenstein","year":"2024","unstructured":"Lichtenstein, M. R. L. et al. Researcher experience and comfort with telemedicine and remote patient monitoring in cancer treatment trials. Oncologist 29, 356\u2013363 https:\/\/doi.org\/10.1093\/oncolo\/oyad237 (2024).","journal-title":"Oncologist"},{"key":"161_CR23","unstructured":"US Food and Drug Administration. Digital health technologies for remote data acquisition in clinical investigations, guidance for industry, investigators, and other stakeholders, 1\u201332. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/digital-health-technologies-remote-data-acquisition-clinical-investigations (2025)."},{"key":"161_CR24","unstructured":"US Food and Drug Administration. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff, 1\u20139. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring (2023)."},{"key":"161_CR25","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1007\/s40273-022-01130-0","volume":"40","author":"M Gomes","year":"2022","unstructured":"Gomes, M., Murray, E. & Raftery, J. Economic evaluation of digital health interventions: methodological issues and recommendations for practice. Pharmacoeconomics 40, 367\u2013378 https:\/\/doi.org\/10.1007\/s40273-022-01130-0 (2022).","journal-title":"Pharmacoeconomics"},{"key":"161_CR26","doi-asserted-by":"publisher","unstructured":"Baumann, S., Stone, R. T. & Abdelall, E. Introducing a remote patient monitoring usability impact model to overcome challenges. Sensors 24, 3977 https:\/\/doi.org\/10.3390\/s24123977 (2024).","DOI":"10.3390\/s24123977"},{"key":"161_CR27","doi-asserted-by":"publisher","first-page":"1043","DOI":"10.1001\/jamaoncol.2016.6749","volume":"3","author":"E Basch","year":"2017","unstructured":"Basch, E. et al. Feasibility assessment of patient reporting of symptomatic adverse events in multicenter cancer clinical trials. JAMA Oncol. 3, 1043\u20131050 https:\/\/doi.org\/10.1001\/jamaoncol.2016.6749 (2017).","journal-title":"JAMA Oncol."},{"key":"161_CR28","doi-asserted-by":"publisher","first-page":"441","DOI":"10.1177\/1740774511410331","volume":"10","author":"SR Warren","year":"2013","unstructured":"Warren, S. R. et al. Medication adherence assessment in a clinical trial with centralized follow-up and direct-to-patient drug shipments. Clin. Trials 10, 441\u2013448 https:\/\/doi.org\/10.1177\/1740774511410331 (2013).","journal-title":"Clin. Trials"},{"key":"161_CR29","doi-asserted-by":"publisher","DOI":"10.1007\/s10916-024-02135-2","volume":"49","author":"SK Kim","year":"2025","unstructured":"Kim, S. K., Park, S. Y., Hwang, H. R., Moon, S. H. & Park, J. W. Effectiveness of mobile health intervention in medication adherence: a systematic review and meta-analysis. J. Med. Syst. 49, 13 https:\/\/doi.org\/10.1007\/s10916-024-02135-2 (2025).","journal-title":"J. Med. Syst."},{"key":"161_CR30","doi-asserted-by":"publisher","first-page":"209","DOI":"10.1007\/s43441-022-00454-5","volume":"57","author":"JA DiMasi","year":"2023","unstructured":"DiMasi, J. A. et al. Assessing the financial value of decentralized clinical trials. Ther. Innov. Regul. Sci. 57, 209\u2013219 https:\/\/doi.org\/10.1007\/s43441-022-00454-5 (2023).","journal-title":"Ther. Innov. Regul. Sci."},{"key":"161_CR31","doi-asserted-by":"publisher","first-page":"3663","DOI":"10.1158\/1538-7445.AM2025-3663","volume":"85","author":"R Palacholla","year":"2025","unstructured":"Palacholla, R. et al. Abstract 3663: a digital health solution for monitoring skin toxicities in cancer treatment. Cancer Res. 85, 3663 (2025).","journal-title":"Cancer Res."},{"key":"161_CR32","doi-asserted-by":"publisher","first-page":"LB143","DOI":"10.1158\/1538-7445.AM2023-LB143","volume":"83","author":"RH Wray","year":"2023","unstructured":"Wray, R. H. et al. Abstract LB143 Improving treatment outcomes: a digital solution for remote patient monitoring of stomatitis for patients receiving Dato-DXd. Cancer Res. 83, LB143 (2023).","journal-title":"Cancer Res."},{"key":"161_CR33","unstructured":"European Medicines Agency. Recommendation paper on decentralised elements in clinical trials, 1\u201339. https:\/\/health.ec.europa.eu\/latest-updates\/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en (2025)."},{"key":"161_CR34","doi-asserted-by":"publisher","first-page":"592","DOI":"10.1177\/1460458219839613","volume":"26","author":"A Kuek","year":"2020","unstructured":"Kuek, A. & Hakkennes, S. Healthcare staff digital literacy levels and their attitudes towards information systems. Health Inform. J. 26, 592\u2013612 https:\/\/doi.org\/10.1177\/1460458219839613 (2020).","journal-title":"Health Inform. J."},{"key":"161_CR35","doi-asserted-by":"publisher","first-page":"801","DOI":"10.1089\/tmj.2013.0329","volume":"20","author":"DK McInnes","year":"2014","unstructured":"McInnes, D. K. et al. The potential for health-related uses of mobile phones and internet with homeless veterans: results from a multisite survey. Telemed. e-Health 20, 801\u2013809 https:\/\/doi.org\/10.1089\/tmj.2013.0329 (2014).","journal-title":"Telemed. e-Health"},{"key":"161_CR36","doi-asserted-by":"publisher","first-page":"e9","DOI":"10.2196\/jmir.2673","volume":"16","author":"SJ Mitchell","year":"2014","unstructured":"Mitchell, S. J., Godoy, L., Shabazz, K. & Horn, I. B. Internet and mobile technology use among urban African American parents: survey study of a clinical population. J. Med. Internet Res. 16, e9 https:\/\/doi.org\/10.2196\/jmir.2673 (2014).","journal-title":"J. Med. Internet Res."},{"key":"161_CR37","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1186\/s41687-022-00492-5","volume":"6","author":"L Newton","year":"2022","unstructured":"Newton, L. et al. Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findings. J. Patient Rep. Outcomes 6, 86 https:\/\/doi.org\/10.1186\/s41687-022-00492-5 (2022).","journal-title":"J. Patient Rep. Outcomes"},{"key":"161_CR38","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1038\/s41746-020-0221-y","volume":"3","author":"RT Sutton","year":"2020","unstructured":"Sutton, R. T. et al. An overview of clinical decision support systems: benefits, risks, and strategies for success. npj Digit. Med. 3, 17 https:\/\/doi.org\/10.1038\/s41746-020-0221-y (2020).","journal-title":"npj Digit. Med."}],"container-title":["npj Health Systems"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s44401-026-00161-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s44401-026-00161-5","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s44401-026-00161-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T21:10:59Z","timestamp":1792012259000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s44401-026-00161-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,14]]},"references-count":38,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["161"],"URL":"https:\/\/doi.org\/10.1038\/s44401-026-00161-5","relation":{},"ISSN":["3005-1959"],"issn-type":[{"value":"3005-1959","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,14]]},"assertion":[{"value":"17 April 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 September 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 October 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"E.P., R.P., and J.B. are employees of Evinova. E.A.S. and S.S. are employees of AstraZeneca. S.P.-J. was an employee of Evinova at the time of the study and is currently affiliated with Emergence Now.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"97"}}