How Patient-Centered Trials Can Improve Biotech ROI

During a panel at the 2025 Patient Centricity & Engagement Conference, a woman shared that clinical trials aimed at “symptom reduction” weren’t as meaningful as a real-life goal: would a trial treatment help her to braid her daughter’s hair again.

That story, recounted in a newsletter by Avalere Health, captures a growing disconnect in healthcare innovation: trials designed to impress investors or regulators often fail to reflect what patients actually value.

While drug developers often tout ‘patient-centricity’ in their mission statements, their decision-making still leaves out or involves the patients they seek to help too late in the process.

“To achieve the best outcomes for patients, a mindset shift is needed,” according to Avalere’s Imogen Brakspear, Senior Strategist, Global Marketing, and Sophie Muzika, Business Unit Director, Global Marketing, in the newsletter. “While being patient-focused shows the good intentions of pharmaceutical companies, it is important to reframe the patient impact as a starting point, not an end goal.”

The gap between what biopharma companies measure and what patients value has been the subject of several industry reports and surveys. The 2025 Edelman Trust Barometer found that only 47 percent of U.S. respondents trust the healthcare system to do what is right.

Most Patient Groups Feel Excluded from R&D

A separate report from PatientView, which surveyed more than 2,500 patient advocacy organizations globally, found that most groups, even those that actively work in partnership with biopharma companies, feel excluded from meaningful roles in helping to guide research and development of new medicines.

In the U.S., only 25 percent of patient groups said they were involved in drug development decisions. That number was similarly low among cancer patient groups, even though many said sponsors formally engaged them.

Patient groups cited the same concerns repeatedly: limited transparency around trial design and pricing, inadequate educational resources, and communication that didn’t reflect their needs.

“True patient centricity means listening, acting on feedback, and making healthcare solutions that are affordable, accessible, and driven by real patient needs—not just corporate priorities,” said one unnamed U.S. advocacy group cited in the PatientView report.

Despite these frustrations, nearly all surveyed U.S. patient groups reported working relationships with at least one pharma company. But the most common form of support, financial grants, rarely translated into influence over trial design or access strategy.

The perception among respondents was that the patient voice is often included late in the process, if at all.

Advocacy Partnerships Outweigh Risks to Fielding Trials

PatientView found that cancer patient groups rated the industry lowest on transparency in clinical trials and on providing accessible, patient-friendly materials. One group said the current system “does not understand patients’ daily reality” and called for deeper involvement outside of clinical studies.

Only 25 percent of U.S. patient groups reported any involvement in trial design. Among the most common requests across groups: clearer communication, earlier engagement, and measurable roles in shaping how success is defined.

Rare disease advocate Tom Larmondra, writing on LinkedIn, described how embedding patient advocates early in the development process can benefit both the companies running the trials as well as patients. He cited a rare disease candidate whose trial protocol was altered after input from advocacy groups, helping secure NIH support and accelerating internal timelines.

“Early industry-advocacy partnerships outweigh risks like trial delays or funding hurdles,” Larmondra wrote. “Beyond informing endpoints, it boosts enrollment - think a 30% uptick by tailoring trials to community barriers - and improves retention with accessible designs.”

Patient Preferences Provide a Clearer Path to Launch

More than half of biotech drug launches underperform commercially, often due to trial designs that fail to demonstrate meaningful value to patients or payers, according to Bennett Smith, SVP of Commercial at a California-based biotech startup in stealth mode.

Smith, who has helped design and implement programs for market access, patient services and sales and marketing at several biopharma companies during the past 20 years ,wrote in Life Science Leader that companies should integrate commercial strategy and patient insight earlier in development.

Smith recommended designing trials to include quality-of-life gains, functional improvements, and caregiver burden reduction – all measures that matter to both patients and reimbursement decision-makers – to improve the odds of having a successful commercial launch of new therapies.

“Translating scientific innovation into commercial success is not just about having the best molecule,” he wrote, “it’s about understanding and adapting to the realities of the market.”