Patient Enrolment and Retention at ICON

Patient recruitment is a complex and intricate process requiring knowledge of human behavior, marketing, management and scientific expertise. ICON has a multi-faceted approach to patient enrolment and retention to ensure successful completion of clinical trials on time and within budget.

Protocol design

The process begins with the protocol design to ensure an appropriate balance between achievement of the scientific objectives (proof of concept, dosing, efficacy, safety) and the practicalities of patient involvement (motivation to participate and stay in the study, ease of participation including number and frequency of visits, acceptability of procedures, impact of being on placebo, etc.). This enables ICON to give sponsors timely feedback and advice if protocol design poses unnecessary
problems or obstacles.

During the protocol design process, ICON’s therapeutic experts, clinical teams, and feasibility and site identification staff, examine the challenges of the study from several critical perspectives, drawing on both their own experience and expertise and that of key investigators to identify successful stategies for enrolment and retention.

Feasibility

ICON uses data from previous feasibility assessments, previous and on-going clinical studies, and feedback from key opinion leaders and investigators to test the practicality of the design to get reliable data on patient accrual and patient and site motivators. The results of the feasibility study may indicate the need for design modification.

Definition of the strategies
Once a study’s target patient population is defined, ICON specialists consider the motivations of both the patient and the site. Involvement in a clinical trial study is not a “once only” decision; retention strategies need to address the on-going motivation to continue.

Every condition and every patient group has unique characteristics and demographics that will respond to different recruitment strategies and messages. ICON’s recruitment strategy produces plans and forecasts of patient recruitment, screening, randomization and drop out rates. It also includes trigger points for implementation of pre-planned contingencies.Article continued >>