Clinical Trials phases of Medical Devices | Contribution of Electronic Data Capture (EDC) software
Clinical validations are often associated with the pharma and biotech industries. However, this also applies to the MedTech sector. The development of a medical devices consists of several phases. These phases include design validation, but clinical validation also plays an essential role in order to obtain a CE mark. For this reason, there is an increasing need for valuable tools during various research phases by contract research organizations (CROs) and MedTech companies. A valuable tool is the Electronic Data Capture (EDC) software. With the use of such a Electronic Data Capture (EDC) system, clinical data can be collected, stored, and enriched in a safe and fast manner. An Electronic Data Capture (EDC) minimizes making mistakes, due to automated input fields, set validations, and set conditions. But it also ensures saving physical storage space, easy data sharing, and flexibility.
In this blog, the classification of Medical Devices and Clinical Trials Phases are explained. We also explain how Electronic Data Capture (EDC) software can be used in a valuable way during the clinical trials of medical devices.
Medical Device Clinical Trials Phases
Clinical research starts after the preclinical research phase has been completed. Clinical research involves testing the medical device with humans. This process is different from Clinical Trial Phases within the pharma and biotech industry:
I | Pilot or exploratory studies
During this clinical research phase, a small study will validate provisional safety and usability. The number of subjects is often still limited to <50 subjects. Despite being a small study, clinical data collection is very crucial. A lot of time and money can be saved, if at an early stage the safety or usability is adequate or not.
Pilot or exploratory studies | Electronic Data Capture (EDC)
By using Electronic Data Capture (EDC) software, building and executing pilot studies can be improved in terms of effectivity and efficiency. Questionnaires can be easily drawn up by the use of study templates and a built-in library. Chapters in the questionnaires can be made recurring for each subject. This is easy for multiple measurement moments. The data can be collected and managed electronically in the Electronic Case Report Form (eCRF). Since there are strict rules for such an EDC system, we recommend paying attention to which strict regulations a specific Electronic Data Capture (EDC) complies with. Complies with the EDC with Good Clinical Practice (GCP) compliance? What kind of certifications contain the supplier (e.g. ISO27001 information security, the NEN7510 standard, and 21 CFR Part 11). Another important question is where the data is stored and whether the data centers also comply with such certifications.
II | Pivotal studies
Pivotal studies are being conducted to get more validation of safety and usability. Multicenter studies are often relevant during this phase. This means that multiple centers (such as hospitals) join a clinical study. The number of patient inclusions is often hundreds, sometimes thousands of them. Clinical validation is close to the design of a medical device. In practice, it happens that adjustments have to be made to the device before market access takes place. This can be in the functional area as well as in the area of safety.
Pivotal studies | Electronic Data Capture (EDC)
In addition to the benefits from pilot clinical trials, an Electronic Data Capture (EDC) can contribute to multicenter trials. Because the environment is web-based, it is possible to have multiple centers participate in a study; anywhere in the world.
Besides, Role-Based Access Management can be used to assign different roles per site. The environment of Electronic Data Capture (EDC) automatically adapts to the rights per role and participating site. This ensures high efficiency, but also a very safe environment where anonymous patient data can be collected.
It is also useful to pay attention to the presence of the functionality built-in notifications. Suspected Unexpected Serious Adverse Reaction (SUSAR) and Serious Adverse Event (SAE) can be created with this functionality. This is essential in the event of an adverse medical event in a patient or subject. When a notification is created for a specific patient, all involved roles (e.g. researchers, data managers) are automatically informed by e-mail.
III | Post-Marketing Surveillance (PMS) studies
When the medical device is launched on the market, a Post-Market Surveillance (PMS) system will ensure that data is systematically collected on quality, performance, and safety. The Post Market Clinical Follow-up (PMCF) is an important part of the Post-Market Surveillance (PMS) system. It is an active collection of data aimed at the clinical validation of the medical device. The activities within a PMCF can range from an analysis of data to conduct a new clinical trial. The PMCF is relevant as it often has a short time horizon during the pre-market phase. As a result, rare events or incidents cannot yet be identified. The unknown risks of the medical device are therefore often only discovered when it is used during normal use.
Post-Marketing Surveillance (PMS) studies | Electronic Data Capture (EDC)
Post Market studies often have many inclusions and multiple centers. Because of the high number of inclusions and multiple measurement moments, sending out questionnaires is seen as a very convenient tool. We recommend choosing an Electronic Data Capture (EDC) that provides such functionality. With such a tool, questionnaires are sent automatically, based on the set schedule. The responsive environment allows patients or test subjects to complete the questionnaires on any device (smartphone, tablet, laptop, computer). The results are automatically sent to the corresponding anonymized patient in the eCRF.
In addition to the benefits during both pilot and pivotal clinical trial phases, collected clinical data in an eCRF should be enriched quickly and easily on the patient level. We recommend checking whether the graphic elements are included in the Electronic Data Capture (EDC) environment.
It is also relevant for data analysts to be able to easily import or export data to common file formats. Think of CSV, Excel, or SPSS.
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