The evidence generation process is divided into four phases based an approximate timeline of when the steps should be taken. The phases are as follows: Phase 1 - basics (establishing general elements related to study design, measurements of outcome, financing and budgeting, regulatory requirements, setting up contact and requirements for clinical collaboration), Phase 2 - Detailed Research Study (e.g., effect size, study design accounting for HTA grading, expected recruitment), Phase 3 - Final Preparatory Steps (finalising study plan and regulatory requirements), Phase 4: Ethics.
Phase 1:
Basics
Indication, Patient Group, Involvement and Treatment Area
Here is presented several weblinks with relevant information on defining the intended use, patient group, treatment area and patient/user involvement. An important need that was highlighted by experts during the development of this tool was the lack of early patient and/or user involvement, as well as the need for inclusive innovation and user design in medical device development
Identifying the right gold-standard control, or comparable technology and its use, is an important enabler for inclusion of data in later evaluation of evidence. More information on this is available through the weblinks below.
Establish Contact with Clinical Stakeholders and Centres
Establishing contact with clinical stakeholders and identifying relevant centres for trials is a common hurdle to evidence generation for medical devices. Clinical Studies Sweden hosts a service for submitting direct requests to healthcare organisations.
The Swedish Medical Products Agency provides resources and guides for meeting the regulatory requirements, according to the Medical Devices Regulations. See link.
Here is presented several weblinks with relevant information on defining the intended use, patient group, treatment area and patient/user involvement.
An important need that was highlighted by experts during the development of this tool was the lack of early patient and/or user involvement, as well as the need for inclusive innovation and user design in medical device development.
Validate Measurement Techniques or Choose other Techniques.
Here is presented several weblinks with relevant information on defining the intended use, patient group, treatment area and patient/user involvement.
An important need that was highlighted by experts during the development of this tool was the lack of early patient and/or user involvement, as well as the need for inclusive innovation and user design in medical device development.
Expected Effect Size(s) and Estimated Number of Study Participants.
Design the Study According to Evidence Grade and Feasability
Clinical study design is challenging for medical devices. This section introduces some of the common challenges and solutions to overcome these. We link to additional resources on evidence grading and clinical study design.
This section can be used as a starting point to explore and plan clinical studies for medical devices.
Evidence Grading
According to SBU's Method Book, evidence is graded according to the Cochrane pyramid, among others (1). The most common included study designs are systematic reviews, randomised controlled trials, non-randomised controlled studies, cohort studies and case series. Healthcare registry data has also been used. In many cases the minimum number of study participants is also stated. This varies between five and 5 000 subjects, or a median of approximately 20 study participants per study or study arm depending on the type of study.
The material below presents some of the medical device-specific challenges to clinical trial design and strategies for overcoming these.
Figure. Left: The Cochrane pyramid for evidence grading. Right: Frequencies of included study designs during health technology assessment.
The figure below presents the IDEAL framework. The model was developed by a consortium of experts to provide guidelines on what type of studies to carry out when in the development cycle of surgical techniques and medical devices to meet the regulatory requirements. The proposed framework provides several learnings for medical devices and evidence generation. To learn more, please review the original research publications and resources cited below.
Figure. IDEAL framework (adapted from Mulloch et al., 2013).
Key Challenges to Clinical Trial Design
The Figure below highlights and explain some of the key challenges to clinical trial design for medical devices.
Figure. Medical-device specific challenges in clinical trial design (adapted from Bernard, et al., 2014 and Neugebauer et al., 2017).
Suggested Solutions
Strategies for overcoming the above challenges are given in the figure below.
Figure. Medical device-specific challenges and strategies to overcome these in clinical trial design (adapted from Bernard, et al., 2014 and Neugebauer et al., 2017).
The number of study participants is an important factor in the evaluation of reliability of clinical data. See this link (Clinical Studies Sweden) for resources on coordinated clinical study requests and clinic requests.
Title
Description.
more info
Phase 3:
Final Preparatory Steps
Create Plan for Data Documentation Tools and Analysis
Here is given information on data collection and statistical analysis strategy. Relevant to this is also to establish a publication strategy for dissemination of clinical research findings. See Clinical Studies Sweden. Planning, Analysis and Publication.
