Common Challenges for Successful Clinical Monitoring of Medical Device 

In brief 

Clinical trial monitoring services are critical for medical progress. Medical technology advancements in recent decades have resulted in earlier and more accurate diagnoses, more successful treatments, and the opportunity for people to live longer healthier lives. However, because new technology is the primary source of rapidly growing healthcare costs, these advancements are not without expense. As a result, a comprehensive examination of medications, supplies, equipment, and even discharge criteria is becoming increasingly important in clinical practice. 

Introduction 

Clinical monitoring is critical to ensuring that accurate clinical data, or clinical evidence, is obtained during medical device clinical trials to back up claims of safety and efficacy. All research-related activities must be carried out in compliance with applicable regulations and clinical trial guidelines, according to the clinical trial sponsor, who assumes primary responsibility for the study. This is achieved through clinical monitoring. The sponsor’s representative, the Clinical Research Associate (CRA), visits the investigational site during clinical monitoring, which may be a hospital or a private practice. The CRA ensures that the clinical trial is carried out according to the Clinical Investigation Plan and that the systematic review writing data submitted to the sponsor is complete and reliable during this visit. Furthermore, the CRA records any findings made during these visits to the sponsor, who may interfere if necessary.  

Medical Device Market Overview   

The Food and Drug Administration (FDA) uses a class system to rank individual devices as low (Class I), intermediate (Class II), or high risk- (Class III). Higher-risk devices must go through a more stringent Premarket Approval (PMA) process, while lower-risk devices may go through a 510(k) process or be excluded. Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), Postmarket Device Reporting, and Postmarket Surveillance (522PMS) are some of the other regulatory paths accessible.   

Medical Device Clinical Trials  

Clinical trials are expected for Class III (high risk) and some Class II (intermediate risk) devices. In comparison to their pharmaceutical counterparts, conducting a systematic review of Medical Device studies face particular challenges, including potential malfunctions of device mechanisms, device trial design and selection of endpoints, operator variability, “learning curve” effect for practitioners using new devices and inability to the blind patient and practitioner. By offering a source of impartial knowledge to review Medical Device research data consistently, an Endpoint Adjudication Committee may help solve the challenges mentioned above. The adjudication of events of interest will help maintain overall research credibility and provide regulators and the scientific community with accurate definitions.  

The basis for successful monitoring  

Open and respectful contact is essential to achieve a successful relationship between the investigational site and the CRA and, ultimately, promote proper clinical supervision. The sponsor, for example, may request additional activities to promote appropriate trial conduct and documentation, which are often not carried out at the investigational site in question. Investigators and site personnel may consider some of these trial activities superfluous or off-point. It is critical that the CRA addresses these issues with the investigational site and describes the intent of the planned activities, particularly in these cases. If the site’s problems are well-founded or cannot be explained, the CRA must express those concerns to clinical trial systematic review services management, who must decide what to do next. Furthermore, the CRA should always allow the site to request more information on unclear processes. The more everyone involved in the clinical trial process understands the activities and difficulties, the better their cooperation will be. 

Challenges for the CRA role  

The CRA must tackle many obstacles to conduct successful clinical surveillance at the investigational site.  

• The amount of clinical data collected and checked within individual clinical trials, as well as the source data given, have a significant effect on the CRA’s workload at the investigational site, with minimal time to conduct all necessary monitoring activities;  
• It’s not unusual for the CRA to operate in cramped spaces, making it difficult to assess all of the necessary documentation;  

• When a CRA arrives on site, they can discover that required documentation is missing, incomplete, or stored in multiple locations;  
• Since investigator and site staff schedules are usually complete, it may be challenging to arrange an appointment with the investigational site;  
• Finally, investigators and site staff have little time to respond to open questions. 

Conclusion  

Clinical trials provide several problems to pharmaceutical businesses across all three research stages, both pre-and post-market studies. However, regardless of phase or research type, our findings consistently demonstrate that embracing digital technology is an essential solution for solving these challenges. Moreover, everything points to our healthcare business becoming unsustainable without decentralized research solutions in an increasingly digitalized society. 

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References  

Anne Tompkins. (2007). Data Management in Clinical Trials. In Principles and Practice of Clinical Research (pp. 67–76). Elsevier. https://doi.org/10.1016/B978-012369440-9/50009-8  

Clausen, I., & Glott, T. (2014). Development of Clinically Relevant Implantable Pressure Sensors: Perspectives and Challenges. Sensors, 14(9), 17686–17702. https://doi.org/10.3390/s140917686