Outcome measures

The value of outcome measures for a patient-first approach 

In today’s regulatory environment, the success of clinical research hinges on the ability to demonstrate meaningful patient outcomes. While the focus on patient experience and developing measures to assess it is a relatively new concept, it is increasingly important in securing regulatory approval.

By starting with patient priorities and combining multiple measurement approaches, sponsors can design more efficient trials that not only demonstrate treatment efficacy but also provide meaningful patient benefits. This approach ultimately accelerates regulatory approval while improving patient outcomes. 

This whitepaper presents a comprehensive framework for implementing meaningful patient-centred outcomes in clinical trials, offering a holistic view of treatment impact. This framework combines:

• Actively collected Clinical Outcome Assessments (COAs): These include Patient-Repored Outcomes (PROs), Observer-Reported Outcomes (ObsROs), Clinician-Reported Outcomes (ClinROs), and Performance Outcomes (PerfOs).
• Digital Health Technologies (DHTs): These technologies, such as wearable devices and mobile applications, capture digital biomarkers and can also passively collect COA data.

Read the whitepaper to explore: 

• The benefits of adopting a patient-first approach in clinical trials
• How to select the right outcome measures
• Common implementation barriers and pitfalls to avoid
• Key strategies for successfully implementing valid and reliable outcome measures