Using a Federated Network of Real-World Data to Optimize Clinical Trials Operations

Topaloğlu, Ümit; Palchuk, Matvey B.

doi:10.1200/cci.17.00067

Cited by 201 publications

(158 citation statements)

References 13 publications

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“…In the area of medical research, especially with regard to cohort identification, several search tools are available. Commercial representatives include, among others, TriNetX [ 18 ], BC Platforms [ 19 ], and Clinerion [ 20 ]. Platforms or projects that make their work available as open source resources are i2b2 [ 21 ], tranSMART [ 22 ], and ConQuery [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

A Federated Online Search Tool for Biospecimens (Sample Locator): Usability Study

Schüttler¹,

Huth²,

Jagwitz-Biegnitz³

et al. 2020

J Med Internet Res

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Background The German Biobank Alliance (GBA) aims to establish a cross-site biobank network. For this endeavor, the so-called Sample Locator, a federated search tool for biospecimens and related data, has been developed, forming the heart of its information technology (IT) infrastructure. Objective To ensure the sustainable use of such a tool, we included researchers as participants in an end user–based usability evaluation. Methods To develop a prototype ready for evaluation, we needed input from GBA IT experts. Thus, we conducted a 2-day workshop with 8 GBA IT team members. The focus was on the respective steps of a user-centered design process. With the acquired knowledge, the participants designed low-fidelity mock-ups. The main ideas of these mock-ups were discussed, extracted, and summarized into a comprehensive prototype using Microsoft PowerPoint. Furthermore, we created a questionnaire concerning the usability of the prototype, including the System Usability Scale (SUS), questions on negative and positive aspects, and typical tasks to be fulfilled with the tool. Subsequently, the prototype was pretested on the basis of this questionnaire with researchers who have a biobank background. Based on this preliminary work, the usability analysis was ultimately carried out with researchers and the results were evaluated. Results Altogether, 27 researchers familiar with sample requests evaluated the prototype. The analysis of the feedback certified a good usability, given that the Sample Locator prototype was seen as intuitive and user-friendly by 74% (20/27) of the participants. The total SUS score by the 25 persons that completed the questionnaire was 80.4, indicating good system usability. Still, the evaluation provided useful advice on optimization potential (eg, offering a help function). Conclusions The findings of this usability analysis indicate that the considerations regarding a user-friendly application that have been made in the development process so far strongly coincide with the perception of the study participants. Nevertheless, it was important to engage prospective end users to ensure that the previous development is going in the desired direction and that the Sample Locator will be used in the future. The user comments and suggestions for improvement will be considered in upcoming iterations for refinement.

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Section: Discussionmentioning

confidence: 99%

A Federated Online Search Tool for Biospecimens (Sample Locator): Usability Study

Schüttler¹,

Huth²,

Jagwitz-Biegnitz³

et al. 2020

J Med Internet Res

View full text Add to dashboard Cite

show abstract

“…Generally, these processes were not designed to and did not work rapidly and in times of peak demand. network (i2b2/ACT) (5), and TriNetX (6). While CDMs enable multi-site, data-driven research, the implementation and maintenance of even one CDM consumes human and other resources.…”

Section: The Pre-pandemic Research Informatics Environment At Ctsasmentioning

confidence: 99%

Research informatics and the COVID-19 pandemic: Challenges, innovations, lessons learned, and recommendations

Bookman

Cimino

Harle

et al. 2021

J. Clin. Trans. Sci.

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The recipients of NIH Clinical and Translational Science Awards (CTSA) have worked for over a decade to build informatics infrastructure in support of clinical and translational research. This infrastructure has proved invaluable for supporting responses to the current COVID-19 pandemic through direct patient care, clinical decision support, training researchers and practitioners, as well as public health surveillance and clinical research to levels that could not have been accomplished without the years of ground-laying work by the CTSAs. In this paper, we provide a perspective on our COVID-19 work and present relevant results of a survey of CTSA sites to broaden our understanding of the key features of their informatics programs, the informatics-related challenges they have experienced under COVID-19, and some of the innovations and solutions they developed in response to the pandemic. Responses demonstrated increased reliance by healthcare providers and researchers on access to electronic health record data, both for local needs and for sharing with other institutions and national consortia. The initial work of the CTSAs on data capture, standards, interchange and sharing policies all contributed to solutions, best illustrated by the creation, in record time, of a national clinical data repository in the National COVID Cohort Collaborative (N3C). The survey data support seven recommendations for areas of informatics and public health investment and further study to support clinical and translational research in the post-COVID-19 era.

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“…Actuellement, la plupart des DPI n'intègre pas de fonctionnalités dédiées aux activités de recherche et n'ont pas la capacité à structurer et standardiser les données pour les rendre exploitables indépendamment du contextesoin ou recherchede manière transparente pour l'utilisateurs [15]. C'est pourquoi, des offres commerciales de services d'optimisation des essais cliniques à destination de promoteurs de recherche clinique se développent [16,17]. Les établissements de santé participant à ces initiatives sont amenés à identifier et standardiser les échantillons de données les plus fréquemment utilisées dans le cadre des essais cliniques ainsi qu'à en améliorer la qualité.…”

Section: Les Données De « Vie Reelle » : Enjeux Avantages Et Limitesunclassified

La recherche clinique à partir d’entrepôts de données. L’expérience de l’Assistance Publique – Hôpitaux de Paris (AP–HP) à l’épreuve de la pandémie de Covid-19

Daniel

2020

La Revue de Médecine Interne

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Using a Federated Network of Real-World Data to Optimize Clinical Trials Operations

Cited by 201 publications

References 13 publications

A Federated Online Search Tool for Biospecimens (Sample Locator): Usability Study

A Federated Online Search Tool for Biospecimens (Sample Locator): Usability Study

Research informatics and the COVID-19 pandemic: Challenges, innovations, lessons learned, and recommendations

La recherche clinique à partir d’entrepôts de données. L’expérience de l’Assistance Publique – Hôpitaux de Paris (AP–HP) à l’épreuve de la pandémie de Covid-19

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