When studies are designed to truly measure what matters, the result is stronger clinical evidence. Start planning your next study for success by downloading our Measure What Matters Checklist.
of adverse events can go undetected.1
of FDA-approved non-expedited drugs provide no health gains versus older comparators.2
of clinical trial participants worldwide are Asian, despite the fact that 60% of the global population is Asian.3
of clinical trials are designed with patient involvement.4
Too often, clinical trial protocols adopt suboptimal study designs. They rely on traditional methods that don’t optimally serve patients, and this is increasingly becoming a bone of contention for regulators. That is because the endpoints and outcomes measures that define study success are not always meaningful to patients or relevant to their day-to-day lives.
To generate stronger evidence, clinical trial sponsors and study teams need to think outside the box—to interrogate the value and suitability of traditional versus more digital methods and ask themselves, “How do we measure the efficacy of a therapeutic in ways that will better translate into meaningful, real-world impact?” The answer to that question should influence protocol design.
When a clinical trial measures what’s important to patients, those patients are more motivated to engage. This results in stronger evidence for your trial and a higher likelihood of market success.
Patients are the experts on living with their conditions. This makes them uniquely qualified to help design clinical trials to measure what matters.
What happens within the 4 walls of a clinic doesn’t always translate to the real world. Incorporating data capture into the daily lives of patients can translate to more accurate, robust data.
Measuring safety is key to a successful clinical trial—yet adverse events are sometimes missed. Remote patient monitoring allows for AE detection in near real time.
The more complex your study design is, the harder it is to capture truly meaningful data. Keep it simple for your participants.
A clinical trial population should look like the real-world population affected by the disease. Racial and ethnic inclusion is important, but also including socioeconomic, geographic, and age diversity can mean your outcomes are more reflective of the real world.
Exploring novel secondary endpoints can help you to measure what’s truly important to your patients and can set your product apart.
Starting to plan your next clinical trial? Plan for success with our downloadable Measure What Matters Checklist. This list covers all the bases to help ensure you get the robust outcomes you need.