Direct-to-patient research: Opportunity brings challenges

Abstract

Direct-to-patient (DTP) research offers promising alternatives to traditional models, potentially improving population-level data collection to understand disease initiation, progression, and response to treatment. Recent reports and commentaries on DTP research, particularly in cancer, suggest major strides forward for both common and rare cancer research and for addressing better data access and representation that can limit the utility of clinical trials. The Multiple Myeloma Research Foundation's (MMRF) CureCloud® Research Initiative built a DTP model for clinical study including genomics, with the goal of creating a platform to provide myeloma patients with their own genomic profile while building a database that combines genomic insights with clinical data to identify trends and support further developments. Patients quickly joined CureCloud, yet several unanticipated outcomes led the MMRF to halt enrollment earlier than projected. This manuscript highlights the generalizable opportunities and challenges experienced during the CureCloud study and suggests that DTP research including genomics or medical records remains extremely complex.

Keywords: Clinical trial design; Clinical trial enrollment; Direct-to-patient research; Multiple myeloma.