Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain.

ABSTRACT: Clinical trials are slow and costly, built around the research centers that study local participants. Building clinical trials around patients in their homes and community through remote visits and monitoring could enhance recruitment and increase convenience for participants. This study evaluated different trial settings, a decentralized arm via telemedicine center (virtual study conduct), a conventional arm via health clinic (onsite study conduct) and a mixed model arm. Acute low-back pain patients (20-65 years) were recruited to this non-interventional trial in Switzerland. The study consisted of a screening period and a 2-week data collection period using direct data capture (eSource), electronic informed consent form (eICF), electronic diary (eDiary) and wearable actigraphy sensor. A

SUBMITTER: Sommer C 

PROVIDER: S-EPMC6072894 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature