PRA Health Sciences announced the launch of its Patient-Centric Trial Development Toolkit, available now to clinical development sponsors focusing on rare diseases. Developed by PRA’s Center for Rare Diseases in collaboration with PRA’s Rare Disease Advisory Committee and other patient stakeholders, the toolkit includes four digital resources designed to mitigate risks that frequently occur in rare disease clinical trials. The toolkit also introduces and affirms new patient-centric practices that promote trial participation. PRA’s rare disease experts and RDAC members recognized a gap in the availability of structured tools for operationalizing patient-centricity in rare disease clinical development. Patients, advocates, and industry leaders in rare diseases collaborated and consulted with PRA to develop four parts of the Patient-Centric Trial Development Toolkit: Patient-Centric Protocol Risk Assessment Tool: Interactive, spreadsheet-based tool that enables sponsors to rapidly identify potential risks, track evolution of risk assessment through stages of the development process and identify potential mitigation strategies. Rapid Participation Burden Survey Tool: An easy-to-use questionnaire development guide that helps sponsors and patient advocates develop a rapid survey for patients and caregivers tailored to their clinical trial’s specific context. The aim of this tool is to help sponsors quantify risk to the clinical program through direct patient engagement. Patient Involvement Value Dossier: This tool outlines the evidence of ROI/benefit involvement in the trial development process from extant literature and provides illustrative case studies from PRA’s Center for Rare Diseases. “What to ask when you’re interested in a clinical trial: A Guide for Rare Disease Patients and Caregivers”: Helps prospective participants identify the barriers to participation they may encounter and request the support they need to enroll and stay in the trial. While the Patient-Centric Trial Development Toolkit does focus on lessening the burden on patients to participate in clinical research, there are also several key benefits for sponsors such as avoiding significant costs related to inefficiency, high trial dropout rates, protocol amendments, and not being able to complete a trial on time.