The Transcatheter and Cardiovascular Therapeutics conference (TCT) has been at the forefront of interventional cardiology research and innovation for more than 25 years – and so it remained, emerging ever more inclusive and innovative, despite – or perhaps because of – the new online format. Aptly named “TCT Connect,” the conference was a celebration of human endeavor and endurance during the pandemic, but also one of outreach to wider audiences than have ever registered in a subspecialty meeting before. As such, even more than the outstanding research and education programs, the highlights of TCT Connect were the enthusiastic audience participation and the profound collaborative spirit between academia, industry, payers, and regulatory agencies. To that end, this brief report will focus on two underreported but exceedingly important conference segments, namely the FDA Town Hall and Medtech Innovation.
The FDA Town Hall included short lectures and spirited discussions that examined the impact of the COVID-19 pandemic on the clinical trial ecosystem and regulatory environment, with particular attention on the complexity of clinical trial management and operations during complete or partial lockdowns, issues with protocol deviations and statistical data interpretation, and consequently unprecedented regulatory concerns and limitations. Nevertheless, most panelists identified the silver linings, such as the rapid adaptation of all key stakeholders in cardiovascular research to the changing landscape. Throughout deliberations, several common elements were readily identifiable and potentially impactful in the long term. Among those, most prominent was the swift implementation of remote patient monitoring and follow up; in parallel, the FDA and payers, including CMS, adjusted policies, and procedures to accommodate the changing patient management environment. Accordingly, digital health and remote monitoring through innovative platforms were at the forefront both in MedTech and FDA Townhall sessions; further, operational aspects for use of digital health in current and future studies were highlighted, with an obvious intent and anticipation that such will continue to evolve and shall require a new operational and regulatory framework in the future. Big data collection and Artificial Intelligence (AI) were discussed within this envisioned framework, though the acronym “AI” was wittingly – and purposefully – referred to as “Augmented Intelligence” to indicate the largely supportive role of AI within a well-informed health care community. Implementation of structured guidelines for virtual patient visits, electronic data collection, and use of adjunct tools for completion of patient monitoring remotely were noted to be a priority. Furthermore, an aggressive push for universal core clinical research data collection compliant with FDA definitions, electronic IRBs, adaptive trial designs and reimagined universal clinical datasets allowing for living, pragmatic clinical trials was made by all stakeholders. Details on novel and impactful nationwide initiatives, including the Heart Valve Collaboratory and Heart Failure Collaboratory, were used as gold-standard references for unified data collection as a method of continuous evaluation of approved or investigational interventions. Such refined datasets will also allow for outcomes analyses of patient populations largely underrepresented in clinical trials, such as women and minorities.
The sessions included several important statements on current practice and policy updates; of those, the following are worth noting, as they apply to the entire field of medicine. First, the FDA reported a significant expansion of early feasibility programs and IDEs as part of a three-step initiative addressing health technology, regulatory flexibility and total product life cycle review, that will allow both rapid and safe patient access to novel therapies. The FDA shifting paradigm towards pragmatic trials, especially in the post-market approval phase, is bound to favorably viewed by all stakeholders. In strong support of a more organic research and regulatory as well as clinical practice ecosystem, the CMS reported that all devices assigned breakthrough designation by the FDA will be covered for four years, during which safety data can be accrued and analyzed, though the accepted methods for data collection were not clarified. Further, alignment of CMS with commercial insurance carriers on coverage for FDA-approved breakthrough therapies was an added indication that the health care sector is unifying against a mutual enemy – that of time – and for a common cause – that of excellence in patient care. Last, in support of clinicians and researchers, CMS has proceeded with implementation of the nationwide coverage determination according to pre-pandemic volume, thus allowing for research sites to continue operating and providing early access to potentially life-saving therapies to as many patients as possible across the country. The latter initiative may enhance access of a more diverse patient population – such as women and minorities – to clinical studies and novel therapeutics.
Dr Martin Leon noted in his opening remarks at the FDA Town Hall: “Never let a pandemic go to waste.” TCT Connect proved that entrepreneurship, novelty, adaptability, and collaboration remain at the core of health care professionals across the entire spectrum of cardiovascular medicine.
Dr Kosmidou is a faculty member at the Cardiovascular Research Foundation, the non-for-profit academic research organization operating TCT.
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