Report from the 2017 Cardiovascular Clinical Trials (CVCT) Conference

By: Debbe McCall 

January 4, 2018

  • Summary:  Report from the 2017 Cardiovascular Clinical Trials Conference November 30-December 2, 2017 in Washington, DC
  • Reading time:  7–9 minutes

This was my first time attending the Cardiovascular Clinical Trials (CVCT) conference. I was an invited speaker along with six other patients! That’s more patients invited to speak than at all the other conferences I have attended this year. Well done! This is mostly a ‘how to do a clinical trial’ conference so it includes researchers, media, funders (NIH, PCORI, etc.), and industry on most panels. Again, it is unusual to have CMS (Medicare), insurance plans, and drug and device companies sitting on the same panels as researchers and patients. These are the presentations that stood out for me.

Integrating Data Science with Evidence Generation

Robert M Califf, MD 

Currently, data science has a narrow definition: someone who programs better than a statistician and analyzes better than a programmer. The preferred definition would be “a member of a team that deals with data in multiple dimensions.“ The next revolution will result from the transformation of information. To apply this fundamental revolution to improve health and quality of life (notice, he didn’t say quantity of life), we must:

  • Learn how to share and create business models that work to improve sharing.
  • Invest heavily in curating information.
  • Work together to develop social and ethical constructs to deal with privacy, confidentiality, and security.
  • Create a workforce that can both create new methods and integrate information into practice.
  • Give the workforce time to invest in knowledge generation as a routine part of practice.
  • Work with the public to gain support and understanding.
  • Develop methods to integrate ubiquitous (everywhere) information about daily life with traditional healthcare information.

 

Utility of Geofencing to Capture Missing Hospitalizations in Clinical Trials

Abhinav Sharma, MD 

Definition: Geofencing is using GPS (in cellphones and other technology) or RFID technology to create a virtual geographic boundary, enabling software to trigger a response when a mobile device enters or leaves a particular area. For example, ‘pizza places near me’, with your web search knowing where you are now because of GPS.

The problem: hospitalizations are often missed as part of clinical trials for many reasons. That also increases the costs of doing clinical trials. There is a significant unmet need for:

  • Accurate and complete evaluation of hospitalizations.
  • Optimizing the capture of safety events.
  • Providing real-time data on patient hospitalizations.
  • Reducing the burden on the study team.

Will geofencing be the answer?

  • Patients do not want to be ‘tracked’.
    • No record of their location unless the patient shows up at the hospital.
    • Depends on the patient having a smartphone.
      • Majority of people are within 3 feet of their phones at all times.
      • Will this increase the work of trial sites?
        • They may spend more time trying to identifya hospitalization versus a vacation or business trip.
        • Will this reduce trial costs?
          • By identifying events quickly and early during the course of a trial, signals for efficacy, safety, or event futility can be identified later.

Geofencing may provide a strategy to capture missed hospitalizations in study participants. Currently, this is being integrated into larger and larger trials. It will NOT replace the fundamental trial structure but will add a layer of security to ensure that hospitalizations are documented. More research is needed to demonstrate the full potential of geofencing in clinical trials.

 

Atrial Fibrillation Trials:

A Deliberately Idiosyncratic Device Industry Perspective

Kenneth Stein, MD

Boston Scientific 

Ok, this presentation was super technical, but he had the BEST cartoon, which sums up how many patients feel about afib treatment.

 

CardioSkin

This was mentioned in one presentation and was part of the poster session. It is a t-shirt with a 12-15 lead 24/7 ECG built in! It also has two-way communication with your EP. So if you’re having palpitations, he’ll see the ECG and contact you to see how you’re feeling. And it’s washable! It was developed from one used to track and document seizures. It’s still in clinical trials. But wouldn’t this be cool? No boxes. No wires. No phone lines. I hope it comes in my size. 

 

Meet the Researcher

Or Speed-Dating Research Ideas

CVCT had another great idea: Meet the Researcher. Experienced researchers signed up to be available for 30–minute blocks. Junior researchers and patients could sign up to meet with them for 10 minutes to pitch a research idea. It also worked in reverse. Several researchers wanted to meet with the patients who were attending the conference to ask about how to include patients, what unanswered questions we had, and how to make trials less burdensome for us. Isn’t that impressive?