Resource utilization for pre‐screening study patients with cognitive disorders.

Abstract

AbstractBackgroundDrug development is a complex, expensive, lengthy, and multifaceted process. Patient recruitment tends to be a considerable and underestimated variable when it comes to planning and implementing a study. More information about evaluating patient sources and resource allocation will allow sites and sponsors to use their resources more effectively and to complete clinical projects earlier.MethodThis paper reviews the sourcing of patients and resource utilisation in hours for 6 pivotal Cognitive Disorder studies by gathering all patients contacted in various phases of a project: pre‐screening, screening, and randomization.ResultSourcing of patients was tracked for pre‐screening, screening and randomisation and are compared in number of calls, resource utilisation (hours), and number of randomized patientsA total of 1 726 patients were pre‐screened, which represents 575 hours of resources, the largest proportion of pre‐screened calls, 43%, was generated from internal database of patients resulting in 46% of randomized patients.The second largest proportion of pre‐screened patients originated from newspapers with 18% of contacts that required 13% of resources and resulted in 14% of randomized patients.Additional sources of pre‐screened calls were conferences (8%), canvassing (7%), friends (4%), medical references (3%), memory day (9%), radio (2%) and web site (2%).ConclusionWe report a pre‐screened/screened/randomized ratio of 23:5:1 indicating that pre‐screening is important to secure patient enrolment though largely underestimated and rarely if ever accounted for in budget assessments. Given the current decline in the use of paper media, alternate solutions must be developed to replace this otherwise successful communication tool. More information is required to better characterize each recruitment method and to determine to which extent the randomization ratio is favorable with each initial source of patients.