How Patient Input can Improve Clinical Trials

I’ve worked in clinical research for almost a decade and I’d never heard this acronym until this week.... ICE = Ideas. Concerns. Expectations. Turns out, it’s one of the most powerful tools in patient care, and almost no one’s talking about it in clinical research. ICE is a framework clinicians use to understand what truly matters to patients, not just what’s medically required. And once I learned it, I couldn’t unsee it. In research, we talk a lot about: 🔹 Eligibility 🔹 Timelines 🔹 Compliance But how often do we stop to ask: 🧠 What does the participant think is happening? 😟 What are they worried about? 🎯 What outcome are they hoping for? Participants don’t enroll just for science. They enroll for: → Hope → Access → Understanding If we don’t ask about their ICE… we miss the very reasons they showed up. So next time you’re reviewing a protocol or prepping for a visit, ask: ✅ What hopes are they bringing into this trial? ✅ Are there unspoken fears we haven’t addressed? ✅ Does the process match the expectations we’ve set? Because ethical research doesn’t start with “eligible.” It starts with empathy. 💬 Ever used ICE in your work? How do you keep patient voice at the center? ♻️ Repost if you believe patient perspectives should shape the future of trials. 🔔 Follow Clinical Research Referral Club (CRRC) for more content on the real side of clinical research.

FDA's Draft Guidance on Diversity Action Plans: 5 Key Areas Where Patient Preference Studies Could Enhance Clinical Trial Diversity The FDA recently released a draft guidance on Diversity Action Plans for clinical trials. As someone deeply involved in patient-centered research, I've reviewed the document and want to share some insights that could be valuable for sponsors, researchers, and patient advocates. The guidance emphasizes opportunities for patient input, but there's an opportunity to strengthen it by incorporating quantitative patient preference studies. Here are 5 key areas where such studies could make a significant impact: 1. Reducing Participant Burden: The guidance recommends "reducing participant burden" (p.14, lines 411-415). Structured weighting methods could quantitatively assess which burdens are most significant to patients, helping prioritize reduction efforts. 2. Enrollment and Retention Strategies: While the FDA "encourages sponsors to consult patients" (p.13, lines 396-398), stated preference methods like conjoint analysis could evaluate patient preferences for different strategies, enhancing effectiveness. 3. Consumer-Friendly Communication: The guidance suggests using "consumer-friendly language" (p.21, lines 706-707). Health state utility methods could quantify how well patients understand different communication approaches, ensuring clarity. 4. Community Engagement: For "implementing sustained community engagement" (p.13, lines 400-403), revealed preference methods could assess the effectiveness of different strategies in real-world settings. 5. Improving Study Awareness: To enhance "study participant awareness and knowledge" (p.14, lines 409-410), best-worst scaling exercises could rank the effectiveness of different strategies from the patient perspective. By integrating these quantitative preference assessment methods, sponsors can create more effective, patient-centered Diversity Action Plans. This could lead to improved enrollment of underrepresented populations and more generalizable clinical trial results. What are your thoughts on the draft guidance? How do you see patient preference studies fitting into the future of clinical trial diversity? #ClinicalTrialDesign #PatientPreferences #FDA #RegulatoryScience #PatientVoice

Patient engagement in the design and conduct of clinical effectiveness trials is increasingly common, and helps to emphasize outcomes that are important to patients. A patient advisory board, which may be involved in all research stages, is one method of formalizing patient engagement. The Patient Centered Outcomes Research Institute (PCORI) has stimulated patient engagement in clinical trials by requiring grantees to detail how their research engages stakeholders, especially patients, and to regularly report engagement strategies and tactics. The Pulmonary Embolism Prevention after Hip and Knee Replacement (PEPPER) Trial: Balancing Safety and Effectiveness, is an ongoing comparative effectiveness trial that was initiated in 2016 and has operated with aPAB since its inception. • Little has been published from the perspective of patient researchers on how they value their involvement as co-investigators in clinical trials. • The PEPPER Clinical Coordinating Team conducted an evaluation of the impact of the PAB on the design and conduct of the Trial and sought to compare and contrast patient and researcher perspectives on their most important contributions to the trial. • PAB members hoped that the results of the trial would lead to better patient–surgeon relationships and shared decision-making while researchers were more focused on trial outcomes, highlighting differences in perspectives that bring value to the design and conduct of the trial. • The contributions of the PAB led to two protocol changes that were very influential on study conduct and eventual outcomes, and will likely aid in encouraging treatment preference discussions between patient and surgeon, thereby supporting the ultimate goal of improved patient outcomes. • Central to having a functional and engaged patient advisory board was the serious consideration of every substantive PAB suggestion in an open minded moderated discussion that produced an outcome that was arrived at by consensus #patientadvisoryboard #patientoutcomes #patientengagement #comparativeeffectiveness #outcomesresearch #patientcenteredoutcomes #realworldoutcomes #healthoutcomes #rwe #realworldevidence #patientcentricity #patientpreferences #clinicalresearch #clinicaltrials #researchmethodology ISPOR—The Professional Society for Health Economics and Outcomes Research International Society for Pharmacoepidemiology Becaris Publishing Limited

A recent meta-analysis of 45 randomized clinical trials has shed light on the critical importance of integrating patient voices into cancer care delivery. The study from Dr. Gordon Guyatt and team spanning from 1996 to 2022 and including over 13,000 participants, reveals that using Patient-Reported Outcome Measures (PROMs) in cancer treatment can lead to significant improvements in patient outcomes. Key findings: -16% reduction in overall mortality risk -Improved health-related quality of life at 12 weeks -Potential for reduced emergency department visits and hospital admissions These results underscore asking patients about their symptoms and treatment tolerability can improve the patient experience and enhance the quality of care. By systematically incorporating PROMs into cancer care delivery clinicians can: -Detect and address issues early (tolerability) -Tailor treatments more effectively -Empower patients in their care journey #PatientCenteredCare #QofL #HealthcareInnovation #PatientVoice #AskPatients #PROMs #PROs https://lnkd.in/gfCgtUhe

💡 I am excited to share the Global Genes new report, developed with the Global Genes Corporate Alliance. This is a comprehensive overview highlighting how patient engagement improves clinical trial feasibility, reduces costs, and accelerates timelines.➔ https://lnkd.in/eZ5X9Vv9 Key Insights from the Report: Elevating Feasibility: Engaging patient communities early provides critical insights that reduce enrollment delays and the need for costly protocol amendments, help identify key trial sites, and more. Qualitative Insights Matter: Understanding the patient experience uncovers barriers, helping drug developers design trials that truly work for rare disease populations. Accelerating Therapies: Engaging patients early reduces costly delays by improving enrollment and retention, allowing drug developers to get their products to market faster. Breaking Down Barriers: By understanding the demands on patients and caregivers, trials can address logistical and procedural challenges that deter participation. Building Trust: Transparent collaboration between industry and patient communities fosters trust, ensuring trials align with patient needs and priorities. This report underscores a powerful message: The patient community is a source of under-utilized expertise that can better inform discovery and development of rare disease therapies. Thank you Gianluca Pirozzi contributing your insights! Charlene Son Rigby Nicole Boice Daniel Levine #EarlyAndOften #GlobalGenes #ClinicalTrialFeasibility #CareAboutRare