Clinical Research: Phase 1 - Phase 4

Designing Trials for Patients

Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions. Listening to patients living with a condition, we can proactively address potential flaws in clinical trial design.

But how do patient concerns translate into operational strategy?

In research, our goal is to gather and analyze information. Measurable endpoints drive action. With a hyper-focus on what’s happening inside the clinic, it may be easy to overlook what’s happening outside. How much time will a daily online questionnaire really take? What does it cost a patient to park at the doctor’s office? There may be simple ways to alleviate these burdens at the outset of a trial by gathering patient feedback.

Beyond the practical aspects of study participation, patient input can impact how we define clinical outcome assessments. When we understand what matters most to patients, we can assess if and how it can be measured.

Consider women experiencing bacterial vaginosis (BV). Many women report feeling unwell, despite being “clinically cured.” In clinical studies, a cure is defined as a resolution of the disease via laboratory measures, rather than considering specific symptoms that women may be experiencing. Without exploring this insight, a secondary endpoint that would enable a better assessment of disease and/or treatment impact may go unassessed. Understanding how women perceive resolution of BV will allow for the development of treatments that address a more robust clinical cure.

Thankfully, there are several avenues for collecting patient insights, many of which are highlighted by the U.S. Food and Drug Administration guidance documents addressing considerations for gathering patient experience data. Advocacy groups are valuable resources, offering access to patient information through survey data, focus groups, and even one-one conversations. Through our regular work in women’s health, we have developed relationships with physicians and site staff that are able to quickly gather and share patient insights. Their daily interactions with patients and our regular monitoring visits at women’s health clinics contribute greatly to how we approach protocol design. Successful research requires identifying partners early in the development process that can offer strategic direction based on real-world experience. Premier Research has completed more than 100 women’s health trials over the past five years. To learn more about our women’s health expertise, click here.