Journal of Lung Diseases & Treatment

Finding the Patients for Respiratory Clinical Trials; Successful Recruitment by Adapting Trial Design

Abstract

Delsing L, Jauhiainen A, Brailsford W, Buxtfeldt C, Sethi T and Betts J

There is increasing need to develop new therapeutics for respiratory diseases such as asthma and COPD, driven by the rising global prevalence, association with significant morbidity and mortality and limited current treatment options. However, recruitment of patients into respiratory trials remains challenging, time-consuming and often very costly. As a consequence, recruitment times frequently have to be extended during the trial to reach the recruitment goal. To identify key changes in trial design which could lead to improved recruitment in respiratory trials, trial recruitment between 1999 and 2012 was analyzed using data from Citeline Trialtrove. The manner by which trials met their recruitment goal was analyzed together with a more in-depth study of trials terminated due to poor recruitment. The percentage of respiratory trials found not to be recruiting to target was substantial (average 26.3%). Whilst no significant changes in recruitment to target were observed during the time period, there appeared to be a trend towards shorter recruitment times. Common features of poorly recruiting trials were very few centers and strict eligibility criteria. Recruitment is central to clinical trials and more complex trials enrolling more specific patient populations will prove increasingly challenging. Therefore, it is important to both consider by what means recruitment will be affected when making trial design decisions and to ensure that every eligibility criteria is as inclusive as possible while still maintaining selection of the right patient population.