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International Clinical Trials

Dodging Delays

Thanks, in part, to earlier disease detection and effective treatments, patients are living longer. As a result, the follow-up period for patients in clinical trials is also being extended. Late recurrence, side effects, and treatmentrelated safety concerns are increasingly important for monitoring. However, patient retention becomes more difficult to achieve as the follow-up period gets longer, with an upsurge in patient drop-outs from 7.3% after 12 months of follow-up to 27% after 48 months (1,2). In fact, 81% of studies in a recent systematic review reported patients lost to follow-up (LTFU), accounting for 2-15% of patients (3).

Why are missing patients a concern? Patients who are LTFU result in missing data and a potential need to recruit additional patients to reach study power. These factors compromise the study budget, timeline, and data quality. Unfortunately, sites often lack the time and resources to track down missing patients, and, although specialist services are available to help find patients, not all provide the same level of service and expertise.

Compromising a Clinical Trial

Missing patients mean missing data. This is problematic when that data would be meaningful for analysis if those patients were available (4). This also introduces bias and could lead to questions regarding the validity of the entire study (3). Dropout rates are rarely the same between treatment groups, and determining if the patients with missing data differ from the patients with complete data is difficult. It has been suggested that 20% of missing patient data could represent a serious threat to validity, while less than 5% of missing data leads to little bias (5,6). However, even small numbers of patients who are LTFU can cause significant bias (7,8).

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Martin Collyer is a Senior Healthcare and Life Sciences Executive with more than 20 years of experience and a focus on multi-site global operations management. He enables organisations to expedite patient enrolment leveraging therapeutically aligned global patient engagement platforms and digital methodologies. Martin is a qualified Chartered Certified Accountant, with a degree in strategic financial planning and management. Prior to joining Bioclinica in 2016, he was Chief Operating Officer of MediciGroup, acquired by Bioclinica.
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