Digitally enabled decentralised research: opportunities to improve the efficiency of clinical trials and observational studies.

Digitally enabled decentralised research: opportunities to improve the efficiency of clinical trials and observational studies.
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以数字化的能力分散研究:提高临床试验和观察性研究效率的机会。

DOI:
10.1136/bmjebm-2023-112253
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发表时间:
2023-10
影响因子:
5.8
通讯作者:
Calvert, Melanie J.
Calvert, Melanie J.
中科院分区:
医学3区
文献类型:
--
作者:
Aiyegbusi, Olalekan Lee;Davies, Elin Haf;Myles, Puja;Williams, Tim;Frost, Chris;Haroon, Shamil;Hughes, Sarah E.;Wilson, Roger;McMullan, Christel;Subramanian, Anuradhaa;Nirantharakumar, Krishnarajah;Calvert, Melanie J.

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背景临床研究通常是以现场为中心的,遵循在很大程度上受传统和操作方便驱动的时间表,而不是疾病的自然病史和目标人群的多样性。1因此,不言而喻,招募到临床试验的患者并不总是反映真实世界的临床表现,这反过来可能会对结果产生偏差,并限制其在真实世界环境中的适用性。然而,在现实中,很少有研究是完全以现场为中心的,治疗通常是在研究现场访问之间在家自我管理的;一些数据捕获也可能发生在现场访问之间--例如,患者报告的结果(PRO)。
BackgroundClinical research is often site-centric, adhering to schedules largely driven by tradition and operational convenience rather than the natural history of diseases, and the diversity of target populations. 1 It stands to reason therefore that the patients recruited to clinical trials do not always reflect real-world clinical presentations, which in turn can bias the findings and limit their applicability to real-world settings. However, in reality, few studies are totally site-centric with treatment often self-administered at home, between study-site visits; some data capture may also occur between site visits—for example, patient-reported outcomes (PROs).
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