Samuel Volchenboum, MD: Quality of life as the new metric for evaluating clinical trials скачать в хорошем качестве

Samuel Volchenboum, MD: Quality of life as the new metric for evaluating clinical trials

Big pharma has a problem. They have no way to reliably track their patients on clinical trials. They receive most of their data long after it has been collected and often too late to make intelligent business decisions. As a result, one in eight drugs never makes it to market despite the billions poured into clinical trials. Interestingly, quality of life is becoming an increasingly important metric by which clinical trials are evaluated. In recent years, the FDA has placed more weight on QoL considerations when deciding whether or not to approve or reject a drug. In fact, they are now requiring QoL as a key endpoint for many drug trials. It is evident that the FDA is taking the view that the treatments we develop should help us live longer and better. Despite the increased focus on how a drug impacts the way a patient continues to live their life, there are no objective ways to measure QoL. Most QoL data are patient-reported, and it’s nearly always collected late in the trial process, at which point the costs of the trial make it literally “too expensive to fail.” The potential of being able to measure and score quality-of-life variables like lifestyle, activity, diet, and environment is tremendous, especially if we can do it early on in a clinical trial’s lifecycle. For pharma, it means the ability to be more agile in the way they do business. It means the difference between failing fast vs. pouring millions more into a drug that is defined to fail. There is also an impact on the end users of these drugs. Being able to move more quickly in the trials phase results in the development costs of these drugs decreasing and can result in higher-quality treatment and meaningfully improved outcomes. In this talk, Dr. Sam Volchenboum with discuss how researchers can employ a continuous multi-stream flow of remote patient data to help steward new insights about whether a given trial is promising (or not) as a business by focusing on QoL endpoints in the early phases of the trial. The result, he will argue, is better business decisions in pharma, which the industry desperately needs, as well as more affordable and more impactful drugs that make patients truly better.