Clinical Trials in Support of Medical Devices

1996 ◽  
Vol 2 (1) ◽  
pp. 45-48
Author(s):  
Richard Kotz
Keyword(s):  
Clinical Trials ◽  
Medical Devices

scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals An Outline for Public Registration of Clinical Trials Evaluating Medical Devices

2006 ◽  
Vol 47 (8) ◽  
pp. 1518-1521 ◽  
Author(s):  
Richard L. Popp ◽  
Beverly H. Lorell ◽  
Gregg W. Stone ◽  
Warren Laskey ◽  
John J. Smith ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Devices

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review

2017 ◽  
Vol 91 ◽  
pp. 111-120 ◽  
Author(s):  
Anne-France Motte ◽  
Stéphanie Diallo ◽  
Hélène van den Brink ◽  
Constance Châteauvieux ◽  
Carole Serrano ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Devices ◽  
Reporting Guidelines ◽  
Implantable Medical Devices

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.

Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan

2021 ◽  
Vol 30 (8) ◽  
pp. 666-676
Author(s):  
Tatsuya Matsuda ◽  
Norihiko Ohura ◽  
Koji Mineta ◽  
Mami Ho ◽  
I Kaku ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Primary Endpoint ◽  
Medical Devices ◽  
Simple Procedure ◽  
Standards Of Care ◽  
Wound Area ◽  
Clinical Endpoints ◽  
Secondary Intention ◽  
Area Reduction ◽  
Definition Of

In consultation with academia and the Pharmaceuticals and Medical Devices Agency (PMDA), we have developed guidance for drafting protocols for clinical trials concerning medical devices for the healing of hard-to-heal wounds without ischaemia. The guidance summarises the validity of single-arm trials for hard-to-heal wounds, the definition of hard-to-heal wounds without ischaemia, methods of patient enrolment and clinical endpoints. This review focuses on the logical thinking process that was used when establishing the guidance for improving the efficiency of clinical trials concerning medical devices for hard-to-heal wounds. We particularly focused on the feasibility of conducting single-arm trials and also tried to clarify the definition of hard-to-heal wounds. If the feasibility of randomised control trials is low, conducting single-arm trials should be considered for the benefit of patients. In addition, hard-to-heal wounds were defined as meeting the following two conditions: wounds with a wound area reduction <50% at four weeks despite appropriate standards of care; and wounds which cannot be closed by a relatively simple procedure (for example, suture, skin graft and small flaps). Medical devices for hard-to-heal wound healing are classified into two types: (1) devices for promoting re-epithelialisation; and (2) devices for improving the wound bed. For medical devices for promoting re-epithelialisation, we suggest setting complete wound closure, percent wound area reduction or distance moved by the wound edge as the primary endpoint in single-arm trials for hard-to-heal wounds. For medical devices for improving the wound bed, we suggest setting the period in which wounds can be closed by secondary intention or a simple procedure, such as the primary endpoint.

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