How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline

Yamatani, Yuki; Saeki, Hiroyuki; Tanaka, Risa; Komeda, Takuji; Watabe, Yukiko; Sakai, Hironori

doi:10.1007/s43441-022-00414-z

Cited by 1 publication

(3 citation statements)

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“… 56 , 57 , 58 While this guidance is helpful, assessing uptake of these guidelines is left to secondary studies, such as suggestions for updates to trial protocols or assessing the use of new ICH standards. 57 , 58 …”

Section: Past Steps Toward a Trial Lhsmentioning

confidence: 99%

“…Other initiatives, such as guidance from non-profit trials group TransCelerate (tranceleratebiopharmainc.com) and the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use (ich.org), provide guidelines, data and protocol standards, and models for quality in trials. [56][57][58] While this guidance is helpful, assessing uptake of these guidelines is left to secondary studies, such as suggestions for updates to trial protocols or assessing the use of new ICH standards. 57,58 On an implementation side, the Accrual to Clinical Trials network aims to support trial conduct by identifying potentially trial-eligible patients across multiple sites in the United States.…”

Section: An Initial Step In Building Amentioning

confidence: 99%

“…[56][57][58] While this guidance is helpful, assessing uptake of these guidelines is left to secondary studies, such as suggestions for updates to trial protocols or assessing the use of new ICH standards. 57,58 On an implementation side, the Accrual to Clinical Trials network aims to support trial conduct by identifying potentially trial-eligible patients across multiple sites in the United States. 59 The National Patient-Centered Clinical Research Network (PCORnet) has also piloted electronic health record (EHR) based strategies to improve the conduct of pragmatic trials.…”

Section: An Initial Step In Building Amentioning

confidence: 99%

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Evolving a national clinical trials learning health system

Stensland

Richesson

Vince

et al. 2022

Learning Health Systems

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Clinical trials generate key evidence to inform decision making, and also benefit participants directly. However, clinical trials frequently fail, often struggle to enroll participants, and are expensive. Part of the problem with trial conduct may be the disconnected nature of clinical trials, preventing rapid data sharing, generation of insights and targeted improvement interventions, and identification of knowledge gaps. In other areas of healthcare, a learning health system (LHS) has been proposed as a model to facilitate continuous learning and improvement. We propose that an LHS approach could greatly benefit clinical trials, allowing for continuous improvements to trial conduct and efficiency. A robust trial data sharing system, continuous analysis of trial enrollment and other success metrics, and development of targeted trial improvement interventions are potentially key components of a Trials LHS reflecting the learning cycle and allowing for continuous trial improvement. Through the development and use of a Trials LHS, clinical trials could be treated as a system, producing benefits to patients, advancing care, and decreasing costs for stakeholders.

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