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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×

References

Adams, B. 2017. Sanofi launches new virtual trials offering with Science 37. https://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-trials-offering-science-37 (accessed November 18, 2018).

Adams, B. 2018. Novartis becomes deeper Science 37 partner, as pair aim for 10-trial launch. https://www.fiercebiotech.com/biotech/novartis-becomes-deeper-science-37-partner-as-pair-aim-for-10-trial-launch (accessed November 18, 2018).

Adams, J. L., K. Dinesh, M. Xiong, C. G. Tarolli, S. Sharma, N. Sheth, A. J. Aranyosi, W. Zhu, S. Goldenthal, K. M. Biglan, E. R. Dorsey, and G. Sharma. 2017. Multiple wearable sensors in Parkinson’s and Huntington disease individuals: A pilot study in clinic and at home. Digital Biomarkers 1(1):52–63.

ALSUntangled Group. 2014. ALSUntangled no. 26: Lunasin. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 15(7–8):622–626.

ALSUntangled Group. 2015. ALSUntangled: Introducing the table of evidence. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 16(1–2):142–145.

Anderson, D. 2018. Digital R&D: Four ways to maximize patient engagement in clinical trials. https://blogs.deloitte.com/centerforhealthsolutions/digital-rd-four-ways-to-maximize-patient-engagement-in-clinical-trials (accessed April 4, 2019).

Apple. 2019. HealthKit. https://developer.apple.com/healthkit (accessed April 25, 2019).

Barrow Neurological Institute. 2017. “ALS at home” study allows people to participate remotely. https://www.barrowneuro.org/researcher-profiles/als-at-home-study (accessed November 15, 2018).

Bedlack, R. 2018. ALSUntangled 44: Curcumin. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 19(7–8):623–629.

Bedlack, R. S., P. Wicks, T. Vaughan, A. Opie, R. Blum, A. Dios, and G. Sadri-Vakili. 2019. Lunasin does not slow ALS progression: Results of an open-label, single-center, hybrid-virtual 12-month trial. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 20(3–4):285–293.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×

Bent, S., R. L. Hendren, T. Zandi, K. Law, J.-E. Choi, F. Widjaja, L. Kalb, J. Nestle, and P. Law. 2014. Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism. Journal of the American Academy of Child and Adolescent Psychiatry 53(6):658–666.

Blumenthal, D. M., K. Yu-Isenberg, J. Yee, and A. B. Jena. 2017. Real-world evidence complements randomized controlled trials in clinical decision making. https://www.healthaffairs.org/do/10.1377/hblog20170927.062176/full (accessed May 30, 2019).

Bohme, M. A., C. Beis, S. Reddy-Alla, E. Reynolds, M. M. Mampell, A. T. Grasskamp, J. Lutzkendorf, D. D. Bergeron, J. H. Driller, H. Babikir, F. Gottfert, I. M. Robinson, C. J. O’Kane, S. W. Hell, M. C. Wahl, U. Stelzl, B. Loll, A. M. Walter, and S. J. Sigrist. 2016. Active zone scaffolds differentially accumulate Unc13 isoforms to tune Ca(2+) channel-vesicle coupling. Nature Neuroscience 19(10):1311–1320.

Business Wire. 2016. eClinicalHealth announces successful results for an entirely remote online clinical trial. https://www.businesswire.com/news/home/20160621005604/en/eClinicalHealth-Announces-Successful-Results-Remote-Online-Clinical (accessed November 18, 2018).

CDC (Centers for Disease Control and Prevention). 2018. All about your A1C. https://www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fdiabetes%2Flibrary%2Ffeatures%2Fa1c.html (accessed April 11, 2019).

CenterWatch. 2017. Sanofi bets on virtual clinical trials. https://www.centerwatch.com/newsonline/2017/03/13/sanofi-bets-virtual-clinical-trials (accessed November 18, 2018).

ClinicalTrials.gov. 2013. Identifier: NCT01302938, web-based methodology trial to evaluate the efficacy and safety of tolterodine ER in subjects with overactive bladder (REMOTE). https://clinicaltrials.gov/ct2/show/NCT01302938?term=REMOTE&cond=Overactive+Bladder&rank=1 (accessed April 4, 2019).

ClinicalTrials.gov. 2016a. Identifier: NCT02709330, ALS reversals—Lunasin regimen. https://clinicaltrials.gov/ct2/show/NCT02709330 (accessed April 25, 2019).

ClinicalTrials.gov. 2016b. Identifier: NCT02833935, enhancing quality of life through exercise: A tele-rehabilitation approach. https://clinicaltrials.gov/ct2/show/NCT02833935?term=virtual+trial&draw=7 (accessed November 22, 2018).

ClinicalTrials.gov. 2017a. Identifier: NCT02655588, a computerized intervention for depression. https://clinicaltrials.gov/ct2/show/NCT02655588?term=virtual+trial&draw=7 (accessed November 15, 2019).

ClinicalTrials.gov. 2017b. Identifier: NCT03172026, maraviroc to augment rehabilitation outcomes after stroke (MAROS). https://clinicaltrials.gov/ct2/show/NCT03172026 (accessed November 18, 2018).

ClinicalTrials.gov. 2017c. Identifier: NCT03266614, “Recovery 4 US”—a photovoice-based social media program (R4US). https://clinicaltrials.gov/ct2/show/NCT03266614?term=virtual+trial&draw=7 (accessed April 20, 2018).

ClinicalTrials.gov. 2017d. Identifier: NCT03291600, virtual psychiatric care for perinatal depression (Virtual-PND). https://clinicaltrials.gov/ct2/show/NCT03291600?term=virtual+trial&draw=3 (accessed April 18, 2018).

ClinicalTrials.gov. 2018a. Identifier: NCT01694667, omega-3 fatty acids for hyperactivity treatment in autism spectrum disorder. https://clinicaltrials.gov/ct2/show/NCT01694667 (accessed April 10, 2019).

ClinicalTrials.gov. 2018b. Identifier: NCT02642393, study of urate elevation in Parkinson’s disease, phase 3 (SURE-PD3). https://clinicaltrials.gov/ct2/show/NCT02642393 (accessed March 18, 2019).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×

ClinicalTrials.gov. 2018c. Identifier: NCT03016897, ALS testing through home-based outcome measures (ALS AT HOME). https://clinicaltrials.gov/ct2/show/NCT03016897 (accessed April 15, 2019).

ClinicalTrials.gov. 2018d. Identifier: NCT03428763, elector treat-to-target via home-based disease activity monitoring of patients with rheumatoid arthritis. https://clinicaltrials.gov/ct2/show/NCT03428763?term=virtual+trial&draw=7 (accessed November 20, 2018).

ClinicalTrials.gov. 2018e. Identifier: NCT03443817, feasibility and effect of a follow up tele-rehabilitation program for chronic obstructive lung disease vs. standard follow up (2-TELEKOL). https://clinicaltrials.gov/ct2/show/NCT03443817?term=virtual+trial&draw=7 (accessed November 20, 2018).

ClinicalTrials.gov. 2019a. Identifier: NCT02168842, efficacy of isradipine in early Parkinson disease (STEADY-PD III). https://clinicaltrials.gov/ct2/show/NCT02168842?term=Steady+PD+III&rank=1 (accessed March 20, 2019).

ClinicalTrials.gov. 2019b. Identifier: NCT02697916, aspirin dosing: A patient-centric trial assessing benefits and long-term (ADAPTABLE). https://clinicaltrials.gov/ct2/show/NCT02697916?term=ADAPTABLE&rank=1 (accessed March 20, 2019).

ClinicalTrials.gov. 2019c. Identifier: NCT03538262, assessing tele-health outcomes in multiyear extensions of PD trials (AT-HOME PD). https://clinicaltrials.gov/ct2/show/NCT03538262?term=AT+HOME+PD&rank=1 (accessed April 24, 2019).

ClinicalTrials.gov. 2019d. Identifier: NCT035924414, trial of Parkinson’s and zoledronic acid (TOPAZ). https://clinicaltrials.gov/ct2/show/NCT03924414 (accessed May 30, 2019).

Cohen, J. C., E. Boerwinkle, T. H. Mosley, and H. H. Hobbs. 2006. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. New England Journal of Medicine 354(12):1264–1272.

Collins, T. R. 2017. Neurologic diseases found to be the largest cause of disability worldwide. Neurology Today 17(22):1–32.

Coravos, A. 2018. Decentralized clinical trials. https://blog.andreacoravos.com/decentralized-clinical-trials-e9dbde90ea95 (accessed January 20, 2019).

CTTI (Clinical Trials Transformation Initiative). 2019a. Decentralized clinical trials. https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials (accessed April 25, 2019).

CTTI. 2019b. Engaging patients and sites. https://www.ctti-clinicaltrials.org/projects/engaging-patients-and-sites (accessed April 25, 2019).

CTTI. 2019c. Mobile technologies. https://www.ctti-clinicaltrials.org/projects/mobile-technologies (accessed April 25, 2019).

CTTI. 2019d. Novel endpoints. https://www.ctti-clinicaltrials.org/projects/novel-endpoints (accessed April 25, 2019).

Cummings, J. L., T. Morstorf, and K. Zhong. 2014. Alzheimer’s disease drug-development pipeline: Few candidates, frequent failures. Alzheimer’s Research & Therapy 6(4):37.

Delaney, J. T., A. H. Ramirez, E. Bowton, J. M. Pulley, M. A. Basford, J. S. Schildcrout, Y. Shi, R. Zink, M. Oetjens, H. Xu, J. H. Cleator, E. Jahangir, M. D. Ritchie, D. R. Masys, D. M. Roden, D. C. Crawford, and J. C. Denny. 2012. Predicting clopidogrel response using DNA samples linked to an electronic health record. Clinical Pharmacology & Therapeutics 91(2):257–263.

Design Kit. n.d. What is human-centered design? http://www.designkit.org/human-centered-design (accessed May 8, 2019).

DiMasi, J. A., H. G. Grabowski, and R. W. Hansen. 2016. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47:20–33.

Dorsey, E. R., J. D. Wagner, M. T. Bull, A. Rizzieri, J. Grischkan, M. A. Achey, T. Sherer, S. Chowdhury, C. Meunier, L. Cappelletti, C. Rocker, I. H. Richard, H. Schwarz, G. Kang, S. H. Ahmad, R. A. Biemiller, and K. M. Biglan. 2015. Feasibility of virtual research visits in Fox Trial Finder. Journal of Parkinson’s Disease 5(3):505–515.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×

El-Toukhy, S., A. Méndez, S. Collins, and E. J. Pérez-Stable. In Review. Beyond the digital divide: Identifying barriers to electronic medical records access and use. Journal of General Internal Medicine.

FDA (U.S. Food and Drug Administration). 2013. Guidance for industry electronic source data in clinical investigations. Silver Spring, MD: FDA.

Fogel, D. B. 2018. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemporary Clinical Trials Communication 11:156–164.

Ford, A., J. Bollyky, J. Schneider, and J. Bridgewater. 2018. Data science approach to monitoring health status for a diabetes population. Paper presented at American Medical Informatics Association Summit, San Francisco, CA, March 15.

Fornai, F., P. Longone, L. Cafaro, O. Kastsiuchenka, M. Ferrucci, M. L. Manca, G. Lazzeri, A. Spalloni, N. Bellio, P. Lenzi, N. Modugno, G. Siciliano, C. Isidoro, L. Murri, S. Ruggieri, and A. Paparelli. 2008. Lithium delays progression of amyotrophic lateral sclerosis. Proceedings of the National Academy of Sciences of the United States of America 105(6):2052–2057.

Geller, S. E., A. R. Koch, P. Roesch, A. Filut, E. Hallgren, and M. Carnes. 2018. The more things change, the more they stay the same: A study to evaluate compliance with inclusion and assessment of women and minorities in randomized controlled trials. Academic Medicine 93(4):630–635.

Gold, M., J. Amatniek, M. C. Carrillo, J. M. Cedarbaum, J. A. Hendrix, B. B. Miller, J. M. Robillard, J. J. Rice, H. Soarres, M. B. Tome, I. Tarnanas, G. Vargas, L. J. Bain, and S. J. Czaja. 2018. Digital technologies as biomarkers, clinical outcomes assessment, and recruitment tools in Alzheimer’s disease clinical trials. Alzheimer’s & Dementia: Translational Research & Clinical Interventions 4:234–242.

Grady, C., S. R. Cummings, M. C. Rowbotham, M. V. McConnel, E. A. Ashley, and G. Gang. 2017. Informed consent. New England Journal of Medicine 376:856–867.

Hale, C. 2018. UCB and Science 37 partner up for virtual, siteless clinical trials. https://www.fiercebiotech.com/cro/ucb-and-science-37-partner-up-for-virtual-siteless-clinical-trials-pediatric-restless-leg (accessed November 15, 2018).

Harrison, D., P. Mehta, M. A. van Es, E. Stommel, V. E. Drory, B. Nefussy, L. H. van den Berg, J. Crayle, and R. Bedlack. 2018. “ALS reversals”: Demographics, disease characteristics, treatments, and co-morbidities. Amytrophic Lateral Sclerosis and Frontotemporal Degeneration 19(7–8):495–499.

Health Measures. 2019. Overview. http://www.healthmeasures.net/explore-measurement-systems/overview (accessed May 8, 2019).

Heneghan, C., B. Goldcare, and K. R. Mahtani. 2017. Why clinical trial outcomes fail to translate into benefits for patients. Trials 18:122.

Hill, N. S., I. R. Preston, and K. E. Roberts. 2008. Patients with pulmonary arterial hypertension in clinical trials. Who are they? Proceedings of the American Thoracic Society 5:603–609.

HiMSS (Healthcare Information and Management Systems Society). 2018. Innovating for infant mortality: HiMSS developer challenge winners announced. https://www.himssinnovationcenter.org/winners-himss-developer-challenge-announced (accessed May 1, 2019).

Holloway, J. 2018. Reaping the benefits of patient-centered clinical research. https://www.science37.com/blog/reaping-the-benefits-of-patient-centered-clinical-research (accessed April 8, 2019).

Hornykiewicz, O. 2010. A brief history of levodopa. Journal of Neurology 257(Suppl 2):S249–S252.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×

IOM (Institute of Medicine). 1994. Women and health research: Ethical and legal issues of including women in clinical studies, Vol. 1. Washington, DC: National Academy Press.

IOM. 2012. Envisioning a transformed clinical trials enterprise in the United States: Establishing an agenda for 2020: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2015. Sharing clinical trial data: Maximizing benefits, minimizing risk. Washington, DC: The National Academies Press.

Jacobs, B. P., S. Bent, J. A. Tice, T. Blackwell, and S. R. Cummings. 2005. An Internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia. Medicine (Baltimore) 84(4):197–207.

Jhadhav, S. 2016. Virtual clinical trials: The future of patient engagement. http://www.appliedclinicaltrialsonline.com/virtual-clinical-trials-future-patient-engagement?pageID=1 (accessed November 15, 2019).

Kamke, K., E. Grenen, C. Robinson, and S. El-Toukhy. In Review. Dropout and abstinence outcomes in a national text-messaging smoking cessation intervention for pregnant women, SmokeFreeMOM: An observational study. JMIR mHealth and uHealth.

Leow, M. K. S. 2016. Glycated hemoglobin (HbA1c): Clinical applications of a mathematical concept. Acta Informatica Medica 24(4):233–238.

Lilly. 2001. e.Lilly venture fund invests in 1747, Inc. https://investor.lilly.com/news-releases/news-release-details/elilly-venture-fund-invests-1747-inc (accessed May 1, 2019).

Madre, L. 2018. A new path forward for using decentralized clinical trials. Presented at Virtual Clinical Trials: Challenges and Opportunities—A Workshop. http://www.nationalacademies.org/hmd/~/media/Files/Agendas/Activity%20Files/HealthServices/Virtual_Trials_WS/Session%204%20%20Leanne%20Madre%20CTTI.pdf (accessed April 20, 2019).

Marlowe, D. B., D. S. Festinger, K. L. Dugosh, K. M. Benasutti, G. Fox, and J. R. Croft. 2012. Adaptive programming improves outcomes in drug court: An experimental trial. Criminal Justice and Behavior 39(4):514–532.

McCambridge, J., J. Witton, and D. R. Elbourne. 2014. Systematic review of the Hawthorne effect: New concepts are needed to study research participation effects. Journal of Clinical Epidemiology 67(3):267–277.

MD Anderson Cancer Center. 2019. The Brief Pain Inventory. https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/brief-pain-inventory.html (accessed May 8, 2019).

Mega, J. L., S. L. Close, S. D. Wiviott, L. Shen, R. D. Hockett, J. T. Brandt, J. R. Walker, E. M. Antman, W. Macias, E. Braunwald, and M. S. Sabatine. 2009. Cytochrome p-450 polymorphisms and response to clopidogrel. New England Journal of Medicine 360(4):354–362.

The Michael J. Fox Foundation. 2019a. About Fox Trial Finder. https://foxtrialfinder.michaeljfox.org (accessed January 9, 2019).

The Michael J. Fox Foundation. 2019b. Fox Insight. https://foxinsight.michaeljfox.org (accessed April 4, 2019).

The Michael J. Fox Foundation. n.d. LRRK2 and Parkinson’s disease. https://www.michaeljfox.org/understanding-parkinsons/living-with-pd/topic.php?lrrk2 (accessed April 4, 2019).

MIYO. n.d. Say hello to make it your own. http://www.miyoworks.org/about (accessed April 18, 2019).

Moore, T. J., H. Zhang, G. Anderson, and G. C. Alexander. 2018. Estimated costs of pivotal trials for novel therapeutic agents approved by the U.S. Food and Drug Administration, 2015–2016. JAMA Internal Medicine 178(11):1451–1457.

NASEM (National Academies of Sciences, Engineering, and Medicine). 2018a. Advancing the science of patient input in medical product R&D: Towards a research agenda: Proceedings of a workshop—in brief. Washington, DC: The National Academies Press.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×

NASEM. 2018b. Returning individual research results to participants: Guidance for a new research paradigm. Washington, DC: The National Academies Press.

NASEM. 2019. Examining the impact of real-world evidence on medical product development: Proceedings of a workshop series. Washington, DC: The National Academies Press.

NIH (National Institutes of Health). 2011. Principles of community engagement, 2nd ed. Bethesda, MD: NIH.

OHDSI (Observational Health Data Sciences and Informatics). 2019. OMOP common data model. https://www.ohdsi.org/data-standardization/the-common-data-model (accessed April 30, 2019).

Okada, Y., D. Wu, G. Trynka, T. Raj, C. Terao, K. Ikari, Y. Kochi, K. Ohmura, A. Suzuki, S. Yoshida, R. R. Graham, A. Manoharan, W. Ortmann, T. Bhangale, J. C. Denny, R. J. Carroll, A. E. Eyler, J. D. Greenberg, J. M. Kremer, D. A. Pappas, L. Jiang, J. Yin, L. Ye, D. F. Su, J. Yang, G. Xie, E. Keystone, H. J. Westra, T. Esko, A. Metspalu, X. Zhou, N. Gupta, D. Mirel, E. A. Stahl, D. Diogo, J. Cui, K. Liao, M. H. Guo, K. Myouzen, T. Kawaguchi, M. J. Coenen, P. L. van Riel, M. A. van de Laar, H. J. Guchelaar, T. W. Huizinga, P. Dieude, X. Mariette, S. L. Bridges, Jr., A. Zhernakova, R. E. Toes, P. P. Tak, C. Miceli-Richard, S. Y. Bang, H. S. Lee, J. Martin, M. A. Gonzalez-Gay, L. Rodriguez-Rodriguez, S. Rantapaa-Dahlqvist, L. Arlestig, H. K. Choi, Y. Kamatani, P. Galan, M. Lathrop, S. Eyre, J. Bowes, A. Barton, N. de Vries, L. W. Moreland, L. A. Criswell, E. W. Karlson, A. Taniguchi, R. Yamada, M. Kubo, J. S. Liu, S. C. Bae, J. Worthington, L. Padyukov, L. Klareskog, P. K. Gregersen, S. Raychaudhuri, B. E. Stranger, P. L. De Jager, L. Franke, P. M. Visscher, M. A. Brown, H. Yamanaka, T. Mimori, A. Takahashi, H. Xu, T. W. Behrens, K. A. Siminovitch, S. Momohara, F. Matsuda, K. Yamamoto, and R. M. Plenge. 2014. Genetics of rheumatoid arthritis contributes to biology and drug discovery. Nature 506(7488):376–381.

Okun, S. 2018. Virtual trials: Access and equity. Presented at Virtual Clinical Trials: Challenges and Opportunities—A Workshop. http://www.nationalacademies.org/hmd/~/media/Files/Agendas/Activity%20Files/HealthServices/Virtual_Trials_WS/Session%203%20%20Sally%20Okun%20PatientsLikeMe.pdf (accessed April 20, 2019).

Orri, M., C. H. Lipset, B. P. Jacobs, A. J. Costello, and S. R. Cummings. 2014. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: Remote trial. Contemporary Clinical Trials 38(2):190–197.

Pew Research Center. 2017. Mobile fact sheet. https://www.pewinternet.org/fact-sheet/mobile (accessed April 18, 2019).

PhRMA. 2012. Drug discovery and development: A long, risky road. A figure found in Overview: new medicines in development for diabetes. http://phrma-docs.phrma.org/sites/default/files/pdf/12-535phrmaoverviewdiabetes1109.pdf (accessed March 10, 2019).

Sabatine, M. S., R. P. Giugliano, A. C. Keech, N. Honarpour, S. D. Wiviott, S. A. Murphy, J. F. Kuder, H. Wang, T. Liu, S. M. Wasserman, P. S. Sever, and T. R. Pedersen. 2017. Evolocumab and clinical outcomes in patients with cardiovascular disease. New England Journal of Medicine 376(18):1713–1722.

Sacristan, J. A., A. Aguaron, C. Avendano-Sola, P. Garrido, J. Carrion, A. Gutierrez, R. Kroes, and A. Flores. 2016. Patient involvement in clinical research: Why, when, and how. Patient Preference and Adherence 10:631–640.

Scannell, J. W., A. Blanckley, H. Boldon, and B. Warrington. 2012. Diagnosing the decline in pharmaceutical R&D efficiency. Nature Reviews Drug Discovery 11:191.

Sharma, N. S. 2015. Patient centric approach for clinical trials: current trends and new opportunities. Perspectives in Clinical Research 6(3):134–138.

SMART. 2017. SMART: Tech stack for health apps. http://docs.smarthealthit.org (accessed May 5, 2019).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×

Taylor, P. 2018. Novartis pushes “virtual” clinical trial concept. http://www.pmlive.com/pharma_news/novartis_pushes_virtual_clinical_trial_concept_1226748 (accessed November 20, 2018).

University of Rochester–Udall Center. n.d. Project 2. https://www.urudallcenter.org/project-2 (accessed May 29, 2019).

VA (U.S. Department of Veterans Affairs). 2018. Blue button. https://www.va.gov/bluebutton (accessed May 5, 2019).

van Eijk, R. P. A., A. R. Jones, W. Sproviero, A. Shatunov, P. J. Shaw, P. N. Leigh, C. A. Young, C. E. Shaw, G. Mora, J. Mandrioli, G. Borghero, P. Volanti, F. P. Diekstra, W. van Rheenen, E. Verstraete, M. J. C. Eijkemans, J. H. Veldink, A. Chio, A. Al-Chalabi, L. H. van den Berg, and M. A. van Es. 2017. Meta-analysis of pharmacogenetic interactions in amyotrophic lateral sclerosis clinical trials. Neurology 89(18):1915–1922.

Wicks, P., T. E. Vaughan, M. P. Massagli, and J. Heywood. 2011. Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm. Nature Biotechnology 29(5):411–414.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice.

On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

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