Joe Martinez
Center Point Clinical Services, USA
Title: Important considerations for successful direct-to-patient study implementation
Biography
Biography: Joe Martinez
Abstract
Currently, ‘patient-centricity’ has gathered visibility and momentum in the media, in the clinical industry and with regulatory authorities as a way to improve trial enrollment, patient retention and study outcomes. Many clinical trials must plan to over-enroll because according to a Tufts Study, 37% of sites under enroll, while 11% do not enroll even one patient. Patient-centricity has become known as “Direct-to-Patient” (DtP) when being discussed as part of a clinical trial protocol. While DtP places the patient at the center of the research process, it engages the patient more directly and can also address geographical challenges in trial operations and logistics. Important items to consider when successfully incorporating DtP into your next clinical trial include: Regulatory Considerations – Policies and acceptable processes vary by country and it’s advisable to begin a dialogue with the appropriate regulatory authority early in the trial planning process. Good Clinical Practices – Clear investigation plan to address the specifics of DtP, and considering a hybrid approach with an option to ‘opt out’. Privacy Laws – Understanding and appropriate guidance to comply with local and global data protection laws. Good Distribution Practices – Well-documented supply chain and processes to ensure chain of custody. Future trials will include a DtP component to address ongoing challenges of patient enrollment, retention, compliance and outcomes. In addition, a decreased number of study sites may provide added benefits of decreased trial costs, increased operational efficiency and enhanced data collection.