Considering the different phases in a clinical trial, there is a need for subjects to be enrolled according to the eligibility criteria defined in the study protocol. Holding the involvement of the right patients is a critical barrier for investigators and sponsors. During the conduct phase of clinical trials, sites usually spend most of their time working on patient recruitment, and yet, statistics show that despite this effort, reaching enrollment goals according to the timeline is frustratingly elusive in many studies.
The industry perspective reflects that it is the unabridged responsibility of the investigator to recruit and retain patients in clinical trials. The methodology adopted is very generic in nature and the same sets of patients from internal databases are referred for different trials. Trends suggest that most of the prescreened eligible subjects are lost before they are enrolled.
There is a need to leverage contemporary technology methods and databases like using Social Media for broadcasting of trials, using healthcare industry databases (HCUP, APCD, etc.) covering Electronic Medical Records, Hospital Discharge Summaries, Claims Data, Patient Registries, Sponsors Internal Databases, and more, to identify the right sites and the right patients. Patient recruitment efforts can be further amplified by mapping and matching patients’ profiles on Blue Button, shared by them to solution providers. The effective use of this information will direct them to precisely register in the right study.
Once enrolled, they need to be supported with the right information and care through the right channels for retention and adherence, as per the study protocol. Solution frameworks supporting the above requirements, depend on: 1) An Information layer to identify the right datasets; 2) An Intelligence layer to apply the inclusion/exclusion criteria; and 3) An Interaction layer to retain the enrolled patients.