Design, Execution, and Management of Medical Device Clinical Trials

Abdel‐Aleem, Salah

doi:10.1002/9780470475911

Cited by 9 publications

(4 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The original per protocol analysis was unaffected by the renewed analysis; as could be expected, the difference in the rate of metabolic acidosis was largest when the study protocol was followed ( p =0.009; Table 3). An ITT analysis is considered less suitable than per protocol analysis in studies evaluating efficiency of medical devices (11). This is due to the complexity of medical technologies used and to the dependence on compliance of the user rather than on the patient compliance, which is of paramount importance in pharmacological studies.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited: analysis of data according to standard versus modified intention‐to‐treat principle

Amer‐Wåhlin

Kjellmer

Maršál

et al. 2011

Acta Obstet Gynecol Scand

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

“…There might be discordance between the two types of analysis (10). Abdel‐Aleem (11) recommended per protocol analysis for assessment of the effectiveness of medical devices and considered ITT more suited for safety evaluation.…”

Section: Introductionmentioning

confidence: 99%

Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited: analysis of data according to standard versus modified intention‐to‐treat principle

Amer‐Wåhlin

Kjellmer

Maršál

et al. 2011

Acta Obstet Gynecol Scand

View full text Add to dashboard Cite

show abstract

“…The approval process of medical devices is relatively new, compared with the process for the drugs (Yin, 2012). In every market the respective regulatory agency defines precise rules of approval for the medical devices (Abdel-Aleem, 2009). They are divided in several classes, depending on the possible risk to the patient.…”

Section: Formal Approval and Reimbursementmentioning

confidence: 99%

Research and Engineering Roadmap for Development and Deployment of Smart Medical Devices

Sliwa

Benoist

2015

Proceedings of the International Conference on Biomedical Electronics and Devices

View full text Add to dashboard Cite

The actual clinical use of smart wireless, software-based, mobile medical devices does not meet the recently raised expectations. First, current low level of interoperability calls for setting and enforcing open standards from the device level to the national/global collaboration structure. Second, heterogeneous and frequently changing devices, operating in various natural, technical and human environments, do not match the classical approval model. In addition to a time-limited set of clinical trials, they need a system of continuous quality monitoring. Third, ad-hoc deployment, without dedicated staff with well defined, novel skill sets is not scalable. A proper organizational structure is necessary. In this paper we present a modular software structure and a framework of a system supporting both the direct health care and the continuous quality evaluation. We expose the location of interfaces crucial for assuring multivendor interoperability. We then define a roadmap giving structure to the necessary development effort. The structure we propose should permit to coordinate the actions of independent teams tackling the immense number of multifaceted and interrelated tasks.

show abstract

“…Therapies may be absent during high-risk conditions (false-negative), and therapies may be delivered during normal or low-risk conditions (false-positive). Device manufacturers and regulators need clinical evidence that MCPSs can reduce the number of false-positives and false-negatives as low as possible [1].…”

Section: Introductionmentioning

confidence: 99%

Model-based Pre-clinical Trials for Medical Devices Using Statistical Model Checking

Yang¹,

Gu²,

Jiang³

2021

Preprint

View full text Add to dashboard Cite

Clinical trials are considered as the golden standard for medical device validation. However, many sacrifices have to be made during the design and conduction of the trials due to cost considerations and partial information, which may compromise the significance of the trial results. In this paper, we proposed a model-based pre-clinical trial framework using statistical model checking. Physiological models represent disease mechanism, which enable automated adjudication of simulation results. Sampling of the patient parameters and hypothesis testing are performed by statistical model checker. The framework enables a broader range of hypothesis to be tested with guaranteed statistical significance, which are useful complements to the clinical trials. We demonstrated our framework with a pre-clinical trial on implantable cardioverter defibrillators.

show abstract

Design, Execution, and Management of Medical Device Clinical Trials

Cited by 9 publications

References 0 publications

Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited: analysis of data according to standard versus modified intention‐to‐treat principle

Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited: analysis of data according to standard versus modified intention‐to‐treat principle

Research and Engineering Roadmap for Development and Deployment of Smart Medical Devices

Model-based Pre-clinical Trials for Medical Devices Using Statistical Model Checking

Contact Info

Product

Resources

About