Heart Valve Studies: 6 key players required for success

As market demand for AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) has exploded, companies face increasing pressure to rapidly deliver actionable clinical trial data. The key to success lies in the team. And the foundation of an effective team begins by understanding each role—and, where applicable, how to best select each team member.

  • Business Management Team: These core team members are responsible for organizing the study—from selecting sites and partners to hiring vendors, setting a budget, establishing communications and managing ongoing operations. Regardless of the study design or explicit indication, the success of this team is key to the success of your device study execution. They lay the foundation for the study, then guide the rest of the team through each phase.
  • Regulators: At every point in your development cycle, regulators are critical members of the team. They have been through the trenches, are very knowledgeable, and will provide diligent feedback. Above all, they appreciate a well-defined plan.
    • Regulatory Requirements: Since regulations will vary depending on whether you are running a regional or global trial, consider your general study requirements and how they relate to country-specific requirements.
    • Timelines: Determine how regulatory requirements will affect your submission flow, and ensure your approval timelines match your regulatory and corporate plans.
  • Patients: These are, perhaps, the most important members of your research team, because without patients there is no trial. As patients globally have become more educated—and patient advocacy groups more powerful—patients’ expectations have increased; it is in your best interest to meet those expectations. You must earn your patient’s trust, understanding how they gain information, how they vet that information, and how they digest that information. You must also consider their lifestyles, constraints and circumstances; your study design fails to take these into account, the study itself may well fail.
  • Sites: Your front-line team members—investigators, OR staff, pharmacy, booking assistants, triage team, ER departments—are clearly vital for your overall success. This relationship is both critical and long-lived—especially in studies with long-term follow up. You need to carefully consider your choices, assessing each site’s feasibility based on the following metrics:
    • Regional and local requirements: What are the regional and local regulatory requirements? How will the site handle them? In some countries, only a site template needs to be submitted, whereas in others, a fully executed document is required as part of the submission packet. Some sites may have their own templates, others may not even have a legal department and will need extra time to go to an outside lawyer.
    • Local standard of care: What is the patient pathway through the site? What is the expected standard of care (which can vary not only regionally, but from site to site), and does it mesh with the contractual obligations you expect from your partners? Does the site understand the obligations they are taking on and how they affect your future plans?
    • Patient pool: Where does the site recruit for studies? Is it through hospital charts or do they collaborate with other practices? How will you have access to your patients?
    • Experience with a similar device: Has the staff worked with a similar device? Do they understand how to utilize it, which patients will be most suitable, how to overcome any complications that may arise?
    • Staff availability: Does the site have the manpower needed to run your study effectively?
    • Expected roles and responsibilities: Throughout your study, you want to ensure that your site staff are knowledgeable about the study specifics and their part in it. By knowing their expected roles, you can arrange appropriate training for those roles, keeping them motivated and ensuring that any issues are handled promptly and effectively.
    • Monitoring access/access to supporting vendors: Will you have clear, ready access to the site, in order to monitor all aspects of your study? Will you have direct access to third party vendors the site uses, who may affect your study in some way?
    • Interest: Why is the site interested in participating in your study? Is their motivation financial, scientific, or the desire to find an alternative treatment option? Understanding their incentives can help you gauge whether the site will ultimately be a good fit.
  • Sponsor/CRO: A host of individual team members fall under this rubric—from the project manager to the lead clinical research associate (LCRA) and their colleagues, medics and medical writers, data managers and biostatisticians. You may have some of these capabilities in-house; you may want to access others from a CRO. Some things to consider when selecting a CRO include:
    • Proposal: What is their understanding of your expectations, your requirements, your needs?
    • Proposed Budget: Have they correctly understood your scope? Have they budgeted appropriately for the geography of your study? Is it sufficiently transparent that you can judge?
    • Staff availability and experience: Do they have existing staff in the region where you are planning to run your study? Do they have not only cardiovascular experience, but experience in heart valves? Have members of the team worked together successfully before?
  • Vendors: Your study may require other team members, such as core labs or translational agencies. Careful and accurate selection is critical to your study’s success. Some relevant considerations include:
    • Which services are required: Be very clear about these.
    • Is a preferred provider status in place: Is this a relationship that worked in past?
    • Past system reviews: What was their performance and satisfaction score?

    Remember to clarify whether regional requirements or your study design potentially trigger the need for additional local vendors.

By carefully constructing your team, you will be laying a strong foundation for heart valve trial to progress swiftly.