A “Measure What Matters” Reality Check


of adverse events can go undetected.1

1. Wahab I, et al. Current Drug Safety. 2023;8(2):104-113.


of FDA-approved, non-expedited drugs provide no health gains versus older comparators.2

2. Darrow J, et al. Health Affairs Forefront. doi: 10.1377/forefront.20171021.268271


of clinical trial participants worldwide are Asian, yet 60% of the global population is Asian.3

3. Sharma A, et al. Nat Rev Dis Primers. 2021;7(74). doi: 10.1038/s41572-021-00316-8


of clinical trials are designed with patient involvement.4

4. Benizri N, et al. JAMA Netw Open. 2022;5(9):e2230858. doi: 10.1001/jamanetworkopen.2022.30858

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.  

5 Reasons to Measure What Matters in Your Clinical Trial

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.

1. Higher compliance and retention

Participants are more willing to complete tasks when they understand their relevance and believe that what’s being measured is important.

2. More accurate data

When outcomes are measured in the real world, the result is more complete and accurate data.

3. Stronger evidence

More accurate data, combined with higher adherence and completion rates, results in studies that are powered to deliver stronger efficacy and safety evidence.

4. Regulatory approval

When the therapeutic evidence is strong, regulatory approval is more probable.

5. Market success

Payors are enticed to cover the therapeutic, and physicians are more likely to prescribe it, when the safety and efficacy evidence is indisputable.

Principles to Help You Measure What Matters

Design with, not just for, patients.

Patients are the experts on living with their conditions. This makes them uniquely qualified to help design clinical trials to measure what matters.

Measure in the real world.

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.

Safety is always critical.

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.

Reduce burden when you can.

The more complex your study design is, the harder it is to capture truly meaningful data. Keep it simple for your participants.

Recruit a representative population.

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.

Don’t be afraid to innovate.

Exploring novel secondary endpoints can help you to measure what’s truly important to your patients and can set your product apart.

Plan Your Next Clinical Trial for Success  

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.