Researcher Much? A Brief Review of TCT’s Clinical Trial Design and Interpretation Sessions

TCT’s Clinical Trial Design and Interpretation Sessions were perfectly formulated to serve a broad audience – from novice to the experts in the field. The methodical approach of starting from the basics and progressively building was particularly important, and very effective, in engaging and educating healthcare providers at all levels. Each session was led by 8-10 expert panelists.

Part 1 (Oct 11, 2015) consisted of the information on the tools necessary to build a successful clinical research enterprise at your own institution and how to maintain quality and accurate data. It further dived into different study designs and their pros/cons—one of my personal favorite parts. A specific emphasis was placed on better understanding the concept of meta-analyses and sub-group analyses—both of which are not immune to flaws. In fact, a meta-analysis is only as good as its component studies. Therefore, instead of putting all the emphasis on summary estimates, it is crucial to assess the quality of component studies.

After establishing the above-mentioned fundamentals of data interpretation, designs of trials such as ISCHEMIA, EXCEL, COMPLETE, and TWILIGHT were then dissected and critiqued.

Part 2 (Oct 12, 2015) was intended to provide different perspectives on some of the more intricate, complex and vital issues surrounding clinical data today. One of the issues that often causes dilemma is what to do when technology moves faster than the data. Some of the current clinical practice guidelines are still based on the data from some of the major, but now outdated, trials. Examples of trials such as COURAGE (only ~ 5% DES used), FREEDOM (first-generation DES), and SYNTAX (first-generation DES) were highlighted to show how the technology used in these major trials is no longer mainstream. Since these trials, technology has evolved rather quickly with better stents, better pharmacotherapy, better judgment of ischemia and use of PCI with hemodynamic evaluation (FFR, iFR), and optimization of PCI with intravascular imaging.

Important concerns were brought up regarding how to reduce this time lag between trial results and guideline updates, how much data is actually necessary to update a guideline, and how to streamline the peer-review process. Perspectives were also presented on whether small RCTs can be practice-changing, looking at endpoints properly and integration of quality-of-life assessment.

FYI: 21st Century Cures Act was passed by the U.S. House of Representatives in July 2015. This bill promotes the development and speeds the approval of new drugs/devices. There was talk of the FDA considering nontraditional study designs and using shorter/smaller clinical trials and evidence from clinical experience, observational studies, registries, and therapeutic use. Having 2 sides to every coin, there are groups advocating for and against it for various reasons. This act also calls for increased NIH funding – (https://www.congress.gov/bill/114th-congress/house-bill/6/text).

In summary, although the sessions may have seemed to be geared towards the academic/research sector, only after attending the sessions I was able to realize their importance and value for any clinician to interpret and integrate clinical research into clinical practice effectively.