ATRI EDC: a novel cloud-native remote data capture system for large multicenter Alzheimer’s disease and Alzheimer’s disease-related dementias clinical trials

Jimenez‐Maggiora, Gustavo; Bruschi, Stefania; Qiu, Hongmei; So, Jia-Shing; Aisen, Paul S.

doi:10.1093/jamiaopen/ooab119

Cited by 5 publications

(8 citation statements)

References 19 publications

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“…To this day, further clinical research remains necessary to address queries concerning the patterns of cervical LNM, neck management strategies for OSCC patients, the scope and timing of neck dissection surgery, and multidisciplinary treatment approaches for patients with LNM. Electronic data capture (EDC) systems, based on internet cloud platforms, have the potential to greatly simplify the complexity of multi‐center, large‐scale clinical research 94 . Despite the era of big data, significant untapped potential exists within the clinical data generated during diagnosis and treatment.…”

Section: Dilemmas and Prospectsmentioning

confidence: 99%

“…Electronic data capture (EDC) systems, based on internet cloud platforms, have the potential to greatly simplify the complexity of multi-center, large-scale clinical research. 94 Despite the era of big data, significant untapped potential exists within the clinical data generated during diagnosis and treatment. Yet, currently, there is considerable heterogeneity in the documentation of medical records and clinical data across global institutions.…”

Section: Neck Dissection Under the Concept Of Precision Medicinementioning

confidence: 99%

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Lymph node metastasis in oral squamous cell carcinoma: Where we are and where we are going

Cao

Zhong

et al. 2023

Clinical and Translational Dis

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BackgroundOral cancer is a common malignant tumour in the head and neck region, with over 90% of cases being oral squamous cell carcinoma (OSCC). Lymph node metastasis (LNM) is a significant adverse prognostic factor in OSCC; however, the mechanism of LNM in OSCC remains unclear, while the strategies for managing cervical lymph nodes (CLNs) in OSCC continue to evolve. At present, neck dissection is necessary for the vast majority of OSCC patients, but complications of surgery can significantly impair patients’ postoperative quality of life. A recent clinical trial discovery indicates that immunotherapy can activate anti‐tumour T cells in nearby lymph nodes, leading to vibrant discussions among clinicians about the importance of preserving lymph nodes during surgical treatment.AimThis review aims to provide an overview of where we are: the current knowledge of OSCC LNM patterns and management strategies, and where we are going: prospects for clinical and basic research on the issue of OSCC LNM in the era of cancer immunotherapy.ResultWe summarize the general patterns and management strategies of OSCC LNM. The process of LNM in OSCC encompasses four stages: Preparation, Unleash, Migration, and Planting (‘PUMP’ principle). We propose adopting the ‘PRECISE’ model, an overall workflow that includes seven elements—prevention, radiology, preoperative evaluation, chemotherapy, immunotherapy, surgery, and postoperative evaluation—for neck management in OSCC, promoting personalized precision medicine augmented by neoadjuvant therapy. We further discussed recent advances in clinical and basic research on OSCC LNM and provided an outlook on future research directions.ConclusionOver the past two centuries, our understanding and management strategies of LNM in OSCC have evolved, seeking more precise and personalized approaches to reduce patient burden and enhance survival and quality of life. Further research should explore lymph nodes’ role in cancer immunotherapy and OSCC interactions, leading to better, less invasive treatments and improved outcomes.

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Section: Dilemmas and Prospectsmentioning

confidence: 99%

Section: Neck Dissection Under the Concept Of Precision Medicinementioning

confidence: 99%

Lymph node metastasis in oral squamous cell carcinoma: Where we are and where we are going

Cao

Zhong

et al. 2023

Clinical and Translational Dis

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“…Logistically, the ultimate aim of connecting trial-ready cohorts with trial enrolment is best facilitated by systems that comply with applicable regulatory requirements and provide seamless data connections to clinical trial data capture systems 74 . In the USA, these systems must comply with the Code of Federal Regulations Title 21, Part 11 (21 CFR part 11) 75 , which establishes the controls and conditions required by the FDA to assure the integrity and validity of electronic records and electronic signatures included in clinical trials submission packages.…”

Section: Building Future Trial-ready Cohortsmentioning

confidence: 99%

Early-stage Alzheimer disease: getting trial-ready

et al. 2022

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Slowing the progression of Alzheimer disease (AD) might be the greatest unmet medical need of our time. Although one AD therapeutic has received a controversial accelerated approval from the FDA, more effective and accessible therapies are urgently needed. Consensus is growing that for meaningful disease modification in AD, therapeutic intervention must be initiated at very early (preclinical or prodromal) stages of the disease. Although the methods for such early-stage clinical trials have been developed, identification and recruitment of the required asymptomatic or minimally symptomatic study participants takes many years and requires substantial funds. As an example, in the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease Trial (the first phase III trial to be performed in preclinical AD), 3.5 years and more than 5,900 screens were required to recruit and randomize 1,169 participants. A new clinical trials infrastructure is required to increase the efficiency of recruitment and accelerate therapeutic progress. Collaborations in North America, Europe and Asia are now addressing this need by establishing trial-ready cohorts of individuals with preclinical and prodromal AD. These collaborations are employing innovative methods to engage the target population, assess risk of brain amyloid accumulation, select participants for biomarker studies and determine eligibility for trials. In the future, these programmes could provide effective tools for pursuing the primary prevention of AD. Here, we review the lessons learned from the AD trial-ready cohorts that have been established to date, with the aim of informing ongoing and future efforts towards efficient, cost-effective trial recruitment.

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“…The definition of processes and an understanding of the DevOps approach help to identify compliance issues [1]. Gaps in timely communication and collaboration are considered critical in introducing compliance issues [63]. Practitioners that are knowledgeable of security compliance issues in DevOps projects [61] are considered a valuable source for receiving more insights on such issues.…”

Section: Initiationmentioning

confidence: 99%

“…In addition to internal frameworks, an organization can partner with third parties to address compliance requirements. The Alzheimer's Therapeutic Research Institute (ATRI) is an example of a collaboration with a third party to establish a compliant IT infrastructure for their system [63]. Since ATRI must deal with health data, ATRI partnered with Amazon Web Services Professional Services for a HIPPA-compliant infrastructure.…”

Section: Initiationmentioning

confidence: 99%

Holding on to Compliance While Adopting DevSecOps: An SLR

et al. 2022

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The software industry has witnessed a growing interest in DevSecOps due to the premises of integrating security in the software development lifecycle. However, security compliance cannot be disregarded, given the importance of adherence to regulations, laws, industry standards, and frameworks. This study aims to provide an overview of compliance aspects in the context of DevSecOps and explore how compliance is ensured. Furthermore, this study reveals the trends of compliance according to the extant literature and identifies potential directions for further research in this context. Therefore, we carried out a systematic literature review on the integration of compliance aspects in DevSecOps, which rigorously followed the guidelines proposed by Kitchenham and Charters. We found 934 articles related to the topic by searching five bibliographic databases (163) and Google Scholar (771). Through a rigorous selection process, we selected 15 papers as primary studies. Then, we identified the compliance aspects of DevSecOps and grouped them into three main categories: compliance initiation, compliance management, and compliance technicalities. We observed a low number of studies; therefore, we encourage further efforts into the exploration of compliance aspects, their automated integration, and the development of metrics to evaluate such a process in the context of DevSecOps.

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ATRI EDC: a novel cloud-native remote data capture system for large multicenter Alzheimer’s disease and Alzheimer’s disease-related dementias clinical trials

Cited by 5 publications

References 19 publications

Lymph node metastasis in oral squamous cell carcinoma: Where we are and where we are going

Lymph node metastasis in oral squamous cell carcinoma: Where we are and where we are going

Early-stage Alzheimer disease: getting trial-ready

Holding on to Compliance While Adopting DevSecOps: An SLR

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