Guest post written by Sue Bhalla
As the latest industry statistics show, an estimated 90% of drugs that reach the testing phase of clinical trials never end up marking the finish line and attaining FDA approval. This leaves potentially useful drug therapies far from entering the market and benefiting patients.
So how does this play in with sarcoidosis? Sarcoidosis is a rare disease, which unfortunately means research within this realm is sparse. Subsequently, with little research comes very few drugs for sarcoidosis patients. The few times drugs relating to sarcoidosis do make it to the testing phase, it is often the failure of clinical trials that keeps these drugs from ever reaching their potential.
Conducting clinical trials poses numerous challenges for pharmaceutical companies. To begin with, pharma cannot be involved in the process of recruiting patients for trials. Instead, they must solely rely on outside sources and third-party recruitment companies to identify and contact patients who are good candidates for a trial. This process can cost up to several thousands of dollars. Even then, an average of 30% of recruited patients drop out of clinical trials. As a result, over two-thirds of trial sites fail to meet the minimum enrollment for the study, ultimately forcing them to withdraw completely. If this happens, it can jeopardize the results of the entire study.
Clinical trials face other various issues like experimental design flaws and administrative setbacks, all of which cause delays that can be extremely costly and eventually result in the premature ending of the trial for a promising drug. With so many obstacles between initial promising results and the final stages of testing for these drugs, it is no surprise how few drugs exist today in the frustrating world of sarcoidosis.
To better ensure that promising, new therapies have a chance at attaining FDA approval, FSR will introduce a new initiative to pave the way for increased success in clinical trials. Using tools like Facebook, Inspire, and the FSR patient registry, we plan to bridge the gap between interested patients and industry leaders. Currently, for example, Reata Pharmaceuticals is sponsoring a study focusing on Bardoxolone methyl, which is a drug thought to increase cellular energy production in cells. Researchers estimate that this could reduce sensations of fatigue and muscle weakness that many sarcoidosis patients experience. In order to accelerate this promising study, FSR is working to identify and reach out to the specific patients who may qualify to participate in this trial. In a way, FSR is investing in research that we find promising by offering our unique tools and resources to accelerate the research process and find new sarc-specific treatments that can help patients. Ultimately, we aim to connect FSR’s network of clinical sites, investigators, physicians, and patients with new advancements in technology, medications, and research with in order to expand, grow, and ultimately better the lives of sarcoidosis patients.
For more information on how drug trials work and cures are discovered, go to: