Remote decentralized clinical trials: a new opportunity for laboratory medicine

被引:4
|
作者
Pennestri, Federico [1 ]
Banfi, Giuseppe [1 ,2 ]
Tomaiuolo, Rossella [2 ]
机构
[1] IRCCS Ist Ortoped Galeazzi, Via Cristina Belgioioso 173, I-20157 Milan, Italy
[2] Univ Vita Salute San Raffaele, Milan, Italy
关键词
decentralized clinical trials; digital medicine; patient-reported outcomes; remote clinical trials; telemedicine; value-based care;
D O I
10.1515/cclm-2022-1184
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
The traditional venue of clinical trials has been hospitals or specialized research units, usually requiring participants to come on-site. Although their contribution to biomedical progress is beyond dispute, they are characterised by two crucial logistical and ultimately scientifical limitations: poor retention and poor generalizability of results, as patients often have problems in concluding the investigation on-site. Remote Decentralised Clinical Trials (RDCTs) take advantage of digital technologies to design trial activities closer to the home of participants, with the aims of minimizing travel to health facilities and the risk of infections, improving the quality of life of participants and caregivers, reducing work absenteeism, including broader cohorts of patients and possibly reducing costs. RDCTs represent a minority of current global research, but the Covid-19 pandemic brought them to the fore. The authors of this paper promote the spread of RDCTs, building on early recommendations from international institutions, and provide some examples of their use and potential benefits in laboratory medicine.
引用
收藏
页码:1388 / 1394
页数:7
相关论文
共 50 条
  • [1] Remote Monitoring and Data Collection for Decentralized Clinical Trials
    Daly, Bobby
    Brawley, Otis W.
    Gospodarowicz, Mary K.
    Olopade, Olufunmilayo I.
    Fashoyin-Aje, Lola
    Smart, Victoria Wolodzko
    Chang, I-Fen
    Tendler, Craig L.
    Kim, Geoffrey
    Fuchs, Charles S.
    Beg, Muhammad Shaalan
    Zhang, Lianshan
    Legos, Jeffrey J.
    Duran, Cristina Ortega
    Kalidas, Chitkala
    Qian, Jing
    Finnegan, Justin
    Pilarski, Piotr
    Keane, Harriet
    Shen, Johanna
    Silverstein, Amy
    Wu, Yi-Long
    Pazdur, Richard
    Li, Bob T.
    JAMA NETWORK OPEN, 2024, 7 (04) : E246228
  • [2] The New Normal in Clinical Trials: Decentralized Studies
    Dorsey, E. Ray
    Kluger, Benzi
    Lipset, Craig H.
    ANNALS OF NEUROLOGY, 2020, 88 (05) : 863 - 866
  • [3] An opportunity to emphasize the relevance of laboratory medicine
    Santamaria Gonzalez, Maria
    Ruiz Minguez, Maria Angels
    Arrebola Ramirez, Maria Monsalud
    Filella Pla, Xavier
    Torrejon Martinez, Maria Jose
    Morell Garcia, Daniel
    Castano Lopez, Miguel Angel
    Allue Palacin, Juan Antonio
    Albaladejo Oton, Maria Dolores
    Gimenez Gomez, Nuria
    ADVANCES IN LABORATORY MEDICINE-AVANCES EN MEDICINA DE LABORATORIO, 2021, 2 (03): : 432 - 440
  • [4] Review of remote ischemic preconditioning: from laboratory studies to clinical trials
    Anttila, Vesa
    Haapanen, Henri
    Yannopoulos, Fredrik
    Herajarvi, Johanna
    Anttila, Tuomas
    Juvonen, Tatu
    SCANDINAVIAN CARDIOVASCULAR JOURNAL, 2016, 50 (5-6) : 355 - 361
  • [5] Nanodiagnostics: A new frontier for clinical laboratory medicine
    Azzazy, Hassan M. E.
    Mansour, Mai M. H.
    Kazmierczak, Steven C.
    CLINICAL CHEMISTRY, 2006, 52 (07) : 1238 - 1246
  • [6] New legal regulations for clinical trials: An opportunity for the future of Clinical Nutrition research
    Deutz, Nicoaas E. P.
    Koletzko, Berthold
    Pichard, Claude
    CLINICAL NUTRITION, 2007, 26 (05) : 510 - 513
  • [7] Cancer epigenetics: from laboratory studies and clinical trials to precision medicine
    Xinyang Yu
    Hao Zhao
    Ruiqi Wang
    Yingyin Chen
    Xumei Ouyang
    Wenting Li
    Yihao Sun
    Anghui Peng
    Cell Death Discovery, 10
  • [8] Cancer epigenetics: from laboratory studies and clinical trials to precision medicine
    Yu, Xinyang
    Zhao, Hao
    Wang, Ruiqi
    Chen, Yingyin
    Ouyang, Xumei
    Li, Wenting
    Sun, Yihao
    Peng, Anghui
    CELL DEATH DISCOVERY, 2024, 10 (01)
  • [9] CLINICAL LABORATORY TEST STANDARDS IN NEW DRUG TRIALS
    HOLDEN, JMC
    ITIL, T
    SIMEON, J
    FINK, M
    JOURNAL OF CLINICAL PHARMACOLOGY AND NEW DRUGS, 1967, 7 (01): : 1 - &
  • [10] Ethical Considerations in Decentralized Clinical Trials
    Bierer, Barbara E.
    White, Sarah A.
    JOURNAL OF BIOETHICAL INQUIRY, 2023, 20 (04) : 711 - 718