艾昆玮-在以患者为中心的时代赋予临床研究机构和赞助商权力（英）

White PaperEmpowering Clinical Research Sites and Sponsors in the Patient-centric Era KERRY GORMAN, Senior Director, Strategic Site SolutionsCOLLEEN GOSA, RNPS Solutions Director, Decentralized TrialsKYLIE SCHEIDELER,Head of Optimization Strategies, AvacareKATY PRECIADO, Director of DCT StrategyREBECCA SAYERS, Head of Site SupportTable of contentsIntroduction 2Patient-centric must first be site-centric 2Solving site decentralized challenges 3Solving site staffing and retention 5Case study: Clinical trial complexity 7Decentralization and more data 7Retaining talent and staffing 7Technology and training 7Patient recruitment & enrollment 8Attracting patients & improving diversity 9Conclusion: sites matter 10About IQVIA 11References 12 iqvia.com | 2In its transformative role, strategic site collaboration can foster patient-centricity by recognizing challenges faced by clinical trial sites and redefining the site as the hub of patient-centric trials. With collaboration instead of delegation, sponsors can decrease site challenges and maintain patient engagement as the industry continues to shift toward a more patient-centric model.Clinical trials are needed, but do biopharmaceutical sponsors, research sites and patients all want the same thing? Yes, to deliver better human health by bringing new medicines to market — but that’s the short answer. Sometimes, clinical trial sites say “no” to participating in a study for reasons beyond enrollment or recruitment.For sites, technology and training can be burdensome. Trial administration is complicated. Staffing levels aren’t adequate. Timelines don’t align. Endpoints are complex. Diseases are rare. Patients are geographically isolated. There are so many challenges it isn’t easy to decide which to focus on. The rapid adoption of Decentralized Clinical Trial approaches (DCTs) has helped to widen patient access, increase participant diversity and reduce overall patient burden. Yet, most clinical trial staff are now given multiple new activities in addition to their standard practices — along with every sponsor’s new technology, new training and new processes. Thus, site personnel feel burdened to keep up and DCT approaches may only be complicating things.As both patients and site staff report a preference for hybrid-designed clinical trials1, the role of the site becomes even more critical. Today’s clinical trial realities dictate that research sites must find the right number and right mix of patients at the right time, continue to support them throughout — and do so on time, on budget and in a way that enhances the patient experience and produces high-quality data. It’s a complex process and many sites are concerned it will become even more burdensome without a seat at the table. The key takeaway is that trial sites don’t want to perform poorly because it impacts their bottom line. Nevertheless, sites, sponsors, and patients can overcome obstacles to successful performance by making trial sites the corne