Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

2021 ◽  
Vol 10 (1) ◽  
pp. 33-36
Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practices ◽  
Situational Awareness ◽  
Implantable Devices ◽  
Wearable Device ◽  
Sleep Habits ◽  
Privacy Issues ◽  
Trial Participants ◽  
Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy

2002 ◽  
Vol 28 (4) ◽  
pp. 361-408
Author(s):  
Lars Noah
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Autonomy ◽  
College Campuses ◽  
Human Experimentation ◽  
Experimental Therapy ◽  
Academic Literature ◽  
Medical Experimentation ◽  
Disclosure Rules ◽  
Near Unanimity

A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

scholarly journals International teleproctoring in neurointerventional surgery and its potential impact on clinical trials in the era of COVID-19: legal and technical considerations

2020 ◽  
pp. neurintsurg-2020-017053
Author(s):  
Emanuele Orru' ◽  
Miklos Marosfoi ◽  
Neil V Patel ◽  
Alexander L Coon ◽  
Christoph Wald ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
High Resolution ◽  
Situational Awareness ◽  
Flow Diverter ◽  
Multiple Sources ◽  
Remote Supervision ◽  
Angiography Suite ◽  
The Us ◽  
Travel Restrictions

BackgroundExisting travel restrictions limit the mobility of proctors, significantly delaying clinical trials and the introduction of new neurointerventional devices. We aim to describe in detail technical and legal considerations regarding international teleproctoring, a tool that could waive the need for in-person supervision during procedures.MethodsInternational teleproctoring was chosen to provide remote supervision during the first three intracranial aneurysm treatments with a new flow diverter (currently subject of a clinical trial) in the US. Real-time, high-resolution transmission software streamed audiovisual data to a proctor located in Canada. The software allowed the transmission of images in a de-identified, HIPAA-compliant manner.ResultsAll three flow diverters were implanted as desired by operator and proctor and without complication. The proctor could swap between images from multiple sources and reported complete spatial and situational awareness, without any significant lag or delay in communication. Procedural times and radiologic dose were similar to those of uncomplicated, routine flow diversion cases at our institution.ConclusionsInternational teleproctoring was successfully implemented in our clinical practice. Its first use provided important insights for establishing this tool in our field. With no clear horizon for lifting the current travel restrictions, teleproctoring has the potential to remove the need for proctor presence in the angiography suite, thereby allowing the field to advance through the continuation of trials and the introduction of new devices in clinical practice. In order for this tool to be used safely and effectively, highly reliable connection and high-resolution equipment is necessary, and multiple legal nuances have to be considered.

scholarly journals Redundant trials can be prevented, if the EU clinical trial regulation is applied duly

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daria Kim ◽  
Joerg Hasford
Keyword(s):  
Clinical Trials ◽  
Health Risks ◽  
Ethics Committees ◽  
Medical Community ◽  
Significant Extent ◽  
Regulatory Requirements ◽  
Trial Participants ◽  
Clinical Trials Regulation ◽  
Clinical Trial Regulation ◽  
The Eu

Abstract The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

scholarly journals Public Approval of Exception From Informed Consent in Emergency Clinical Trials

2019 ◽  
Vol 2 (7) ◽  
pp. e197591 ◽  
Author(s):  
William B. Feldman ◽  
Spencer P. Hey ◽  
Jessica M. Franklin ◽  
Aaron S. Kesselheim
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Public Approval

scholarly journals Defining the Threshold of Permissible Risk for Non-therapeutic Clinical Trials with Children in Europe

2017 ◽  
Vol 24 (4) ◽  
pp. 414-431
Author(s):  
Katherine Wade*
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Medicinal Products ◽  
Council Of Europe ◽  
Therapeutic Trials ◽  
Research With Children ◽  
Individual Trial ◽  
The One ◽  
Definition Of ◽  
Trial Participants

Abstract It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.

Abstract 3769: Barriers to Obtaining Informed Consent in Acute Stroke Clinical Trials

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Sacha R Masuca ◽  
Devsmita S Das ◽  
Deji Delano ◽  
Malcom Irani ◽  
Renga Pandurengan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Acute Stroke ◽  
Single Center ◽  
Severe Stroke ◽  
Single Center Study ◽  
Investigational Therapies ◽  
Clinical Trial Enrollment ◽  
Barriers To Enrollment ◽  
Clinical Research Trials

Background Identification of barriers to enrollment in acute stroke clinical trials may identify ways to improve enrollment and expedite completion of clinical research trials. In this exploratory analysis we sought to evaluate the differences in presenting characteristics between patients who are able to provide informed consent (IC) compared with those who were enrolled by the legal authorized representative (LAR). Methods From our single center, prospectively collected registry, we identified consecutive patients with acute ischemic stroke (AIS) who presented to our emergency department and were enrolled into acute (<8hrs from symptom onset) prospective clinical treatment trials. Data collected included arrival time, thrombolysis time, IC time, source of IC (LAR or patient), aphasia or neglect and method of arrival. For analysis, the patients who were consented by a LAR were compared with patients who provided their own IC. Results From 2003 - 2011, we identified 124 patients who met inclusion criteria. There were no differences in age, sex, presentation or door to needle times (Table 1). Patients who were able to provide IC presented with less severe stroke (p<0.0001). Aphasia and neglect were significantly more common when a LAR provided IC (p<0.0001). LAR consent required a significantly longer amount of time (90 vs. 71 min., p=0.04). Conclusions In our single center study, we found that patients with milder stroke are able to provide IC and the presence of aphasia or neglect can hinder enrollment in the absence of a LAR. In addition, when patients are able to provide IC, they do so almost on average 20 minutes faster than the LAR. Additional evaluation is necessary to determine the reasons for delay. Since good outcomes with investigational therapies for AIS treatment are likely to be time dependent, further efforts should target improvement of the IC process to minimize delay in clinical trial enrollment.

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