Although the device works in theory, a long road lies between conceptualization to actualization. Because this product claims to assist patients with injuries by providing a drug to their system, it will first need to undergo pre-clinical, phase I, and phase II trials before proceeding to potentially several phase III and IV clinical trial on humans to establish the appropriate formula and demonstrate its safety and efficacy. Also, according to the FDA, a drug patch is classified as a combination device, and thus its simpler parts, such as the ice bag and elastic bandage, would qualify as Class I devices, while the actual drug-eluting patch would classify as a Class III device, since theoretically, misuse could threaten life.
In order to get the drug to market, if first has to undergo pre-clinical trials, which utilize studies on animals as well as on the drug purity and production process. These serve to understand “1) the drug’s safety in doses equivalent to ...view middle of the document...
A phase III clinical trial will have a clinical target, a goal, and an endpoint. The purpose of this device is to deliver steroids to an injury site to prevent and contain swelling to promote healing. Thus the target for the device could include practically anyone, but initially would be marketed to sports trainers, who could quickly use them on athletes. Currently the standard for care involves elastic bandages and watery ice packs. Several weeks after the injury, patients can get a steroid shot. The benefit of this new device would be simpler and quicker care, resulting in faster recovery times. The endpoint of the clinical trial will be injury recovery time, compared to the current standard of injury response and recovery (Umscheid).
Finally, once the drug is FDA-approved, the FDA or sponsors may require a phase IV study, which aims to “1) identify less common adverse reactions, and 2) evaluate cost and/or drug effectiveness in diseases, populations, or doses similar to or markedly different from the original study population. Although most drugs pass this phase, there is a slight chance the device will need warning labels, or could be pulled altogether (Umscheid).
Because less than 1% of people have injected steroid allergies (More), the clinical study would have to prescreen for allergies, but otherwise the study group would ideally contain as many people as possible, especially those as injury-prone as athletes, to get the best representation of the target population. Ideally, the trial would be double blind—some of the patches would simply be ice, and some would contain the steroids, but neither patient nor study staff would know the difference. This would yield the most objective results for the patch efficacy.
Only after all of these steps are completed will the drug be allowed to continue to market. This situation is somewhat unique, because it is essentially a combination of combination products—while the Class I components will not be hard to get approval, due to previous models and successes, the drug-eluting patch will be far more difficult. While steroid shots have become a standard, there is a significant lack of steroid-patch data, which pose a challenge to the clinical trials as it is a new and unknown field.