Overview of Medical Device Clinical Trials

2017 ◽  
pp. 17-32 ◽  
Author(s):  
B.A. Fiedler ◽  
M. Ferguson
Keyword(s):  
Clinical Trials ◽  
Medical Device

scholarly journals Web Based Data Capture for Clinical Research

10.28945/3201 ◽  
2008 ◽  
Author(s):  
Stephen Smith ◽  
Samuel Sambasivam
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Device ◽  
Rapid Development ◽  
Research Data ◽  
Data Capture ◽  
Electronic Data Capture ◽  
Proof Of Concept ◽  
Web Based ◽  
Tools And Techniques

Electronic Data Capture (EDC) is increasingly being used in the pharmaceutical, biotech and medical device industries to gather research data worldwide from doctors, hospitals and universities participating in clinical trials. In this highly regulated environment, all systems and software must be thoroughly tested and validated, a task that is burdensome in terms of time and cost. Starting with database structures that are designed to be copied easily, this paper proposes a simple framework that allows for rapid development and minimal testing. The framework includes tools for building modules, for copying modules from one trial to the next, and tools to validate that the modules are the same as modules that have been fully tested previously. A proof-of-concept prototype has been built to demonstrate certain tools and techniques that can be used when designing and building a simplified EDC interface.

Clinical Trials for Medical Device Innovators

2018 ◽  
pp. 101-107
Author(s):  
William D. Voorhees ◽  
Theodore W. Heise
Keyword(s):  
Clinical Trials ◽  
Medical Device

scholarly journals An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials

2017 ◽  
Vol 376 (14) ◽  
pp. 1350-1357 ◽  
Author(s):  
Owen Faris ◽  
Jeffrey Shuren
Keyword(s):  
Clinical Trials ◽  
Medical Device

Bayesian Approaches in Medical Device Clinical Trials: A Discussion with Examples in the Regulatory Setting

2011 ◽  
Vol 21 (5) ◽  
pp. 938-953 ◽  
Author(s):  
Pablo Bonangelino ◽  
Telba Irony ◽  
Shengde Liang ◽  
Xuefeng Li ◽  
Vandana Mukhi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Bayesian Approaches

scholarly journals Design and analysis of high-risk medical device clinical trials for diabetes monitoring and treatment

2019 ◽  
Vol 2 (4) ◽  
pp. 123-130
Author(s):  
Bo Zhang ◽  
Sravya B. Shankara ◽  
Shangyuan Ye ◽  
Hui Zhang
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Medical Device ◽  
Diabetes Monitoring

Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update

2020 ◽  
Vol 13 (2) ◽  
pp. 94-109
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
A.C. Rana ◽  
Monu Yadav ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Studies ◽  
Healthcare Sector ◽  
Regulatory Body ◽  
Class Iii ◽  
General Control ◽  
Dental Floss ◽  
The Usa

Background: Need for Medical devices is very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In the USA, a regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which looks the manufacture, packaging and use of medical devices in the USA. Objective: In USA, Medical devices are classified into 3 classes: class I which look for the medical devices used for the general control as dental floss and bandages, etc., class II which regulate the medical devices used for the general control as well as special control as powered wheelchairs and pregnancy kits. Class III medical devices look the general control. PMA (Premarket Approval) and Premarket Notification application has been filed to FDA for seeking the market authorization of medical devices. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. These trials are performed on various age groups such as on paediatrics, adult and old age group commonly called phase 1,2,3,4. Regulatory approval of high-risk medical device is based on clinical studies submitted with pre-market approval. The main objective of this article is to make the researcher aware of the regulation and clinical trials of medical devices in the USA. Conclusion: Every medical device should comply with FDA, QMS and QSR for marketing in the USA. The present article has focused on the regulation of medical devices, clinical trial phases and clinical studies on medical devices.

An Account of how Attention to Usability and Lifestyle Issues may Contribute to Protocols for Clinical Trials of Medical Devices (Preprint)

2017 ◽  
Author(s):  
Lars Rune Christensen ◽  
Lene Nielsen ◽  
Anne Sabers
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Randomized Clinical Trials ◽  
Case Report Form ◽  
Data Generation ◽  
Pragmatic Approach ◽  
Double Blind ◽  
Sham Procedure

UNSTRUCTURED Objectives: Within the field of medicine attempts have been made to establish the efficacy of new treatments with medical devises by double blind randomized clinical trials. Very precise protocols have been developed for this purpose. However, experience has shown that conducting clinical trials on medical devices may be fraught with trouble often because of the difficulty of establishing a valid sham procedure. This paper makes a contribution by showing how one may formulate protocols for clinical trials of medical devices that rely on a pragmatic approach, which includes an interest in usability and lifestyle issues, rather than a sham procedure. Our case in point is a protocol for a clinical trial, conducted by the authors, of a new kind of treatment of epilepsy with a medical device. Methods: This paper makes a methodological contribution relevant for the formulation of protocols for clinical trials of medical devises in cases where a sham devise is not practical. Results: In the paper, we make three major points: (1) abandoning basing a clinical trial of a medical device on a sham procedure, involves making choices as to the formulation of a pragmatic alternative, (2) shifting to a pragmatic evaluation based on data on for example continued use, may involve generating data on usability and lifestyle issues. Understanding to what degree noncompliance is due to usability or lifestyle issues requires attention to the design of suitable instruments for data generation, and (3) the successful formulation of a protocol for a clinical trial of a medical device (where sham is not an option) relies on a case report form (CRF) that facilitates the separation of data on the (somatic) efficacy of the treatment from data on usability and lifestyle issues. Conclusion: Digital devices play an important role in medicine today and in the future. This paper makes a contribution by showing how one may formulate protocols for clinical trials of medical devices that do not rely on a sham procedure. The approach is based on a pragmatic approach, the generating data on usability and lifestyle issues connected to the use of the devise, and the separation of these issues from the evaluation of the efficacy of the active component of the treatment.

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