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Incomplete reporting of recruitment information in clinical trials of biological agents for the treatment of rheumatoid arthritis: A review
Arthritis Care & Research , 05/08/2012
Simsek I et al. – A substantial majority of RCTs conducted in RA patients with biological agents did not provide sufficient information about the patient recruitment process, which makes assessments of external validity difficult. The rate of reporting of the recruitment process in this study was found to be lower as compared to similar studies conducted in different specialties.
Methods- PubMed was searched for all reports of RCTs involving etanercept, infliximab, adalimumab, golimumab, certolizumab, abatacept, tocilizumab and rituximab in RA patients.
- Data recorded were: eligibility fraction, enrollment fraction, recruitment fraction, and number of patients needed to be screened (NNS) in order to randomize one participant.
- Of the 66 trials included in the analysis, 23 (35%) reported the number of individuals assessed by investigators for eligibility, 18 (27%) reported the number eligible for participation.
- Of the studies that reported quantitative recruitment information, the median eligibility fraction was 80.6% (IQR, 71.8% to 91.1%) and the median enrolment fraction was 100% (IQR, 88.4% to 100%).
- The median NNS was found as 1.28 (IQR, 1.18 to 1.43).