Translating Results from Clinical Trials Into Practice

Clinically significant results from trials, and even safety and efficacy approvals based on findings from clinical trials, does not necessarily mean a product or device will be successful in clinical practice or in the marketplace. Too often the sponsor’s marketing team is eager to promote a study’s meaningfully significant efficacy results and its low adverse event profile, but they may overlook that only 50% of treated subjects reach the primary efficacy endpoint, or that there may be pain or downtime that, while low in quantity or transient in nature, are still significant enough to dissuade subjects from wanting or recommending the treatment. Each year, highly anticipated products come to market with grand enthusiasm, but fail to commercially deliver because the issues that will make it successful in practice are either not measured in the study or have not been gleaned from busy, discerning clinicians and investigators.

Clinical studies are often designed for approvals or for claims, but not for success. For the sponsors, your impressive outcomes in a pivotal study are fantastic and a reason to get excited, but I recommend speaking with principal investigators or hold advisory boards with experienced clinicians to gain insights into best practices.

If half my study patients are not satisfied with the outcome, or 30% think it is too painful regardless of how good the results may be, they will likely opt for another treatment once the product gets launched. My suggestion to industry leaders is to think commercially when designing studies and communicate candidly with clinical advisors when designing the trials, as well as the period after the trial is completed. Be diligent and open to feedback. Adverse events that are deemphasized or glossed over may sink the product after launch. It is often the case that morbidities and risks can be mitigated and/or cured by simple solutions that the investigators discovered during the trial. Additionally, other markets, such as those in Europe or Asia, may already have worked through the issues and figured out best practices.

For providers being courted by sales teams or dancing reels, express cautious optimism and a healthy dose of skepticism when evaluating new aesthetic product and or devices. Ask colleagues who were in the clinical trials or friends overseas about their experiences. Poke holes in the papers, presentations, and reports. Attend conferences both in the U.S. and abroad. Seek out advisory boards. Don’t rely on social media posts and anecdotal stories for all your information.

A bit of patience and prudence sometimes goes a long way in serving patients when considering the latest and greatest shiny new thing.