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GlobalCare Clinical Trails, USA
Title: Innovative Patient-Centric Service Model Helps Speed Patient Recruitment and Increase Retention in Virtual and Traditional Study Designs
Abstract

Patient recruitment and retention are key factors, and generally the most challenging, in meeting the objectives and success of clinical trials. Clinical trial costs, complexity and development timelines have continued to increase over the past several years as well as the burden to participating patients and caregivers. We are approaching a critical juncture where traditional trial designs can no longer be justified or sustained. More patient-centric trial models and novel trial designs incorporating mobile technologies are available to make studies more patient-friendly as well as more cost efficient. A patient-centric service model has evolved over the past two decades allowing study visits to be conducted at the patient’s home where it is more convenient and comfortable than at the investigator site. By conducting selected protocol visits at home, the workplace or other alternate location, ambulant healthcare providers offer a way for patients to participate in trials regardless of typical barriers of study duration, visit frequency, disease state, distance to site, site office hours, or family, school or work obligations. By making trials more convenient for patients, this service model has demonstrated that more patients are willing and able to participate and remain in studies. Virtual study (central-site) designs have been introduced to also address real world challenges to gain access to hard to reach patients residing in rural areas and those who may have mobility issues and to utilize available technologies to remotely consent and monitor patients. There still remains the need for local clinical support to obtain safety labs or train patients on utilizing the mobile devices. The use of ambulant healthcare providers to conduct at-home study visits can result in significantly more cost-effective, efficient and patient-friendly clinical trial programs conducted globally than traditional studies. This session will: • Explore the use of an innovative, patient-centric approach to conducting selected study visits via an ambulant healthcare network to reduce patient burden and other barriers to study participation • Show how conducting selected protocol visits at the patient’s home or alternate location rather than at the investigator site can make study participation more convenient and comfortable for patients resulting in faster recruitment and better compliance and retention • Present case studies using ambulant care services • Demonstrate win-win benefits for all stakeholders

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