As digital therapeutics are integrated into every aspect of the healthcare landscape, patients, payers, and providers are seeing an increasingly complex set of software-driven therapy options reaching the market. This rapidly expanding field has enormous potential but faces challenges at every stage, from design to patient perception. Focusing on the clinical trial stage, how does the trial of a digital therapeutic compare to that of a pharmaceutical? What are the specific challenges of running a digital therapeutics clinical trial, and how can sponsors adapt their approach for the highest chance of success?
There may be as many as 7,000 rare diseases. The European Union defines a disease as rare when it affects less than one in 2,000 people. According to the Orphan Drug Act, a rare disease affects less than 200,000 people in the United States. Support from FDA, EMA and other regulatory agencies, combined with technological and scientific advances, have made it more feasible for pharmaceutical companies to give dedicated attention to orphan drug development. In doing so, they're developing medications for rare diseases that often have no cure and no available treatment. To ensure novel therapies advance from the lab to regulatory approval, a blockbuster-drug approach won't work. Managing rare disease studies to completion requires innovative thinking in nearly every phase of program development. Those willing to become trailblazers have the highest odds of success.
Biorasi’s Oncology Center of Excellence remains at the forefront of this exciting field. Our team of clinicians, program managers and other experts stay up to date on the latest developments, from Tumor Infiltrating Lymphocyte (TIL) therapy to gene therapy advances. This experience, combined with Biorasi’s worldwide site network and data-driven approach, allows us to guide oncology programs to success—on time and on budget.
A clinical trial's operational efficiency depends on a solid oversight and response mechanism. Without vigilant monitoring, patient safety, data integrity, and the overall health of your trial come into jeopardy.
It's rare for any large project that involves hundreds of individuals and multiple locations to proceed without some sort of hiccup. Budgets get stretched, schedules run [...]
Eczema affects more people in the United States than diabetes (10.1 vs. 9.4 million)1,2. More than 8 million Americans have psoriasis.3 Considering how common some skin [...]
Each year, doctors diagnose about 1,000 Americans with cystic fibrosis, a rare hereditary disease that affects about 30,000 people in the United States. Thanks to advances [...]
The numbers vary but multiple surveys confirm what we all know: patient recruitment is one of the most challenging and important aspects of running a clinical [...]
The success of any clinical trial depends on unbiased data. However, the subjective nature of many dermatology assessments makes unbiased data harder to come by. Inconsistent [...]
Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
The study is behind schedule. Enrollment is lagging. The protocol is too complicated. Approximately 80 percent of all clinical studies need intervention or optimization to be successful, [...]