Family genetic studies
It is acknowledged that even in common diseases such as viral bronchiolitis, investigators may struggle to enrol the appropriate numbers of patients, and the recruitment process was time consuming and needed careful planning.
Abstract
Recruitment issues The success of any clinical study is dependent on the investigators’ abilities to recruit sufficient patients to participate. Consideration of recruitment is important when designing study protocols because by developing complex, detailed inclusion and exclusion criteria, the pool of patients available to include in the study becomes smaller. Having been involved in developing studies from within the pharmaceutical industry, one of us (WL) has worked with over optimistic clinicians convinced they will be able to recruit the required number of patients for a particular study. It is relatively common, however, that studies fail as a result of incomplete recruitment. Information on these failures is impossible to obtain as such studies are never published. Twenty years ago studies were published without appropriate power calculations and with small numbers of patients. Not so today. Recruitment is therefore an important issue as it is acknowledged that even in common diseases such as viral bronchiolitis, investigators may struggle to enrol the appropriate numbers of patients.1 Given the trend towards studies with larger numbers of patients, a recent Medline search into recruitment policies related to clinical trials was disappointing. Of 703 articles of possible interest, 93 were studies in children, but many of these addressed issues such as ethics, consent, patient participation attitudes, and recommendations as to how to maintain patients’ interest once they had been recruited into the study.2–4 Others reported issues which were specific to diseases such as cancer.5 A paediatric growth hormone study in renal failure6 expressed concern that the bond between families and professionals may have coerced families into agreeing to the study. The paper also confirmed that the recruitment process was time consuming and needed careful planning. A recent family study into the genetics of asthma in Stoke caused us considerable recruitment problems; …