Clinical Registries to Evaluate Focused Ultrasound Therapies: A Detailed Examination

Written by Rick Hamilton

The Focused Ultrasound Foundation has long championed the importance of clinical data registries in today’s rapidly evolving therapeutic landscape. The value that clinical registries offer is multifaceted and critical to advancing patient care and medical understanding. Below I have outlined the four main advantages gained from registries and described the three main ways the Foundation works to facilitate their use.  

1. Evaluating Longitudinal Outcomes  
Monitoring patients over extended (longitudinal) periods of time is crucial. Long-term follow-ups shed light on how patients respond to a treatment over time, and these results can be instrumental in assessing the longer term efficacy and safety of treatments. By tracking patient outcomes over the long run, clinical registries offer clinicians a nuanced understanding that can guide future treatment decisions. 

2. Defining and Evaluating Best Practices  
Consistency in healthcare is paramount, and clinical registries play a pivotal role in defining and evaluating best practices. By analyzing vast amounts of data from various sources, registries can identify patterns and correlations that lead to optimal patient outcomes. These findings then set the benchmark for healthcare professionals, ensuring that patients receive care rooted in evidence and proven methodologies. 

3. Developing Treatment Guidelines  
Based on the aggregated data and insights gleaned, clinical data registries can assist in the formulation of standardized treatment guidelines. These guidelines, in turn, act as reference points for clinicians, ensuring that they have a roadmap to provide the most effective care possible. 

4. Furthering Research and Therapeutic Development  
Clinical registries act as rich repositories of data, facilitating further research. For instance, by analyzing trends, anomalies, or correlations in these databases, researchers can identify potential areas for therapeutic development or areas needing more rigorous investigation. 

As the healthcare field continues to evolve, so does the regulatory framework surrounding it. Increasingly, clinical data registries are not just supplementing but in certain cases replacing or complementing traditional sources of evidence, such as randomized clinical trials. The data they offer may provide swifter paths to reimbursement, catering to insurers’ demands for concrete health economics and outcomes data. This includes insights into treatment durability and how various therapies influence quality of life. 

Given these pivotal roles, the Foundation doesn’t just advocate for the clinical data registries but actively encourages their usage growth. This involves several strategic moves: 

Convening stakeholders: The Foundation creates opportunities to gather relevant parties to decide on data requirements and standards, ensuring the collected data are of the highest quality and relevance. 

Creating an ecosystem inventory/landscape analysis: The Foundation documented the current focused ultrasound registry landscape to identify gaps, opportunities, and areas for collaboration. 

Facilitating connections: The Foundation seeks to be a nexus for connecting diverse parties based on business interests. This may involve linking manufacturers with registry vendors or aligning vendors with cloud computing providers to streamline and optimize data storage and analysis processes. 

The Foundation’s call extends to all members of the clinical data registry ecosystem. Collaboration is vital for all medical equipment manufacturers, clinical investigators, data analytics providers, and any other stakeholders. 

In conclusion and as a call to action, the Foundation is eager to engage in dialogue on this seminal topic. Through collective efforts, we can ensure that a vast treasure trove of patient data is utilized to its utmost potential to advance care and understanding for all those involved in the global focused ultrasound community. 

Be a Part of the Conversation 

We encourage the community’s thoughts or questions on this topic. If you are in a position to influence the creation or use of focused ultrasound registries, we would love to hear from you at

Rick Hamilton is the Foundation’s managing director and chief technology officer. He is currently recognized as the 15th most prolific inventor in world history, with over 1,040 issued US patents.