A recent Forbes article details the unseen world of individuals who pose as appropriate participants for multiple clinical studies to reap the rewards that stipends provide. Networking via social media has refined the process to include a ‘scout’ participant who relays study inclusion/exclusion criteria to the group to ensure that all who follow know just how to answer each of the many questions about symptoms, medications, co-morbidities, etc. This practice has obvious implications for the quality and interpretability of all aspects of study results.
How can such a scheme bypass the careful review of the medical records and relevant medical history of these patients as they are considered for study participation? What does this indicate about the process of patient consenting in these situations? Will lie detectors become standard equipment in the settings where informed consent is obtained?
These gaps in capturing a prospective study subject’s health history and status are an outcome of the ‘patient mill’ system that may develop when enrollment for a study is opened to the services of a vendor outside the clinical site who then advertises the study to all patients who may be interested. In doing so, the enrollment pool is increased to the benefit of the study, but the resulting parade of interested patients may arrive with unknown medical history and no direct means to verify the information provided by the individuals consented. In this setting, patient-provided information may not be verified. As the article describes, modern social connections can support the use of this gap in verified patient information to provide opportunists a chance to gain an income stream from the study and potentially destroy the integrity of the results in the process.
This unfortunate and wasteful situation adds another powerful call for addition of SSRO services to the professional support involved with study management. As a complementary addition to the services of a traditional CRO, the SSRO model works only with known patients seen regularly at each business associate clinical site. Through a thorough and continued review of patient medical records at the site, the capture of confirmed health status, history and use of medications is a part of the pre-screening process and ensures that each study subject enrolled is 100% aligned with the study inclusion/exclusion criteria. This site aligned approach also tracks ongoing medical events for enrolled subjects to address any changes to medications and diagnoses that may be updated during the course of a study. This key information is outside the allowed access of the traditional CRO, who is a contracted agent of the study sponsor.
Since an SSRO has the ability to utilize patient information from electronic medical records as a business associate of the site, the number of correctly enrolled patients (meet I/E criteria) is increased by 5-30 times the average number. Therefore, outsourcing and advertising to enroll patients is unnecessary.
Addition of this SSRO services approach for capture of all study participants results in only truly relevant patients being enrolled and ensures return on investment for pharma whose greatest need in getting support for approval of their product for marketing is high quality investigative sites and readily interpretable study data.