Background Recruitment for clinical trials continues to be a challenge, as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies. Objective This study aimed to conduct a systematic review and meta-analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic/offline recruitment methods. Methods Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial), as well as study characteristics and patient demographics were collected from the included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, a nonparametric paired Wilcoxon test was used for additional analysis on the cost-effectiveness of online patient recruitment. All data analyses were conducted in R language, and P<.05 was considered significant. Results In total, 3861 articles were screened for inclusion. Of these, 61 studies were included in the review, and 23 of these were further included in the meta-analysis. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared with offline recruitment (incidence rate ratio [IRR] 4.17, P=.04). When examining the entire recruitment period in months we found that 52% (12/23) of the studies had a better online recruitment rate compared with the offline recruitment rate (IRR 1.11, P=.71). For cost-effectiveness, we found that online recruitment had a significantly lower cost per enrollee compared with offline recruitment (US $72 vs US $199, P=.04). Finally, we found that 69% (9/13) of studies had significantly better offline conversion rates compared with online conversion rates (risk ratio 0.8, P=.02). Conclusions Targeting potential participants using online remedies is an effective approach for patient recruitment for clinical research. Online recruitment was both superior in regard to time efficiency and cost-effectiveness compared with offline recruitment. In contrast, offline recruitment outperformed online recruitment with respect to conversion rate.
Background Increasing costs and complexity in clinical trials requires recruitment of more narrowly defined patient populations. However, recruitment for clinical trials remains a considerable challenge. Aim Our overall aim was to quantify recruitment performance in industry-sponsored phase III clinical trials conducted globally during 2008–2019 with primary aim to examine development of overall clinical trial measures (number of trials completed, number of participants enrolled, trial duration in months) and key recruitment metrics (recruitment rate, number of sites, number of patients enrolled per site). Methods The publicly available AACT database containing data on all trials registered at ClinicalTrials.gov since 2008 was used. The analysis was completed during three time periods from 2008–2019 of 4 years each. Results and conclusion Recruitment duration for industry-sponsored phase III clinical trials have increased significantly during the last 12 years from an average recruitment period of 13 months (IQR 7–23) in 2008–2011 to 18 months (IQR 11–28) in 2016–2019 (p = 0.0068). Further, phase III clinical trials have increased the number of registered sites per clinical trial by more than 30% during the last 12 years from a median number 43 sites (IQR 17–84) in 2012–2015 to 64 sites (IQR 30–118) in 2016–2019 (p = 0.025), and concurrently, the number of participants enrolled in clinical research has decreased significantly from 2012–2015 and 2016–2019 (p = 0.046). We believe that these findings indicate that recruitment for phase III clinical trials is less effective today compared to 12 years ago.
BACKGROUND Recruitment for clinical trials continues to be a challenge as patient recruitment is the single biggest cause of trial delays. Around 80% of trials fail to meet initial enrollment target and timeline, and these delays can result in up to as much as $8 million per day in lost revenue for drug developing companies. OBJECTIVE To conduct a systematic review and meta analysis examining the effectiveness of online recruitment of participants for clinical trials compared with traditional in-clinic / offline recruitment methods. METHODS Data on recruitment rates (the average number of patients enrolled in the study per month and per day of active recruitment) and conversion rates (the percentage of participants screened who proceed to enroll into the clinical trial) as well as study characteristics and patient demographics were collected from included studies. Differences in online and offline recruitment rates and conversion rates were examined using random effects models. Further, non-parametric paired Wilcoxon test was used for additional analysis on cost-effectiveness of online patient recruitment. All data analysis was conducted in R-Language, and P<.05 was considered significant. RESULTS : In total 3,861 articles were screened for inclusion. Of these, 61 studies were included in the review and 23 of these were further included in the meta analyses. We found online recruitment to be significantly more effective with respect to the recruitment rate for active days of recruitment, where 100% (7/7) of the studies included had a better online recruitment rate compared to offline (IRR 4.17, P = .038). When examining the entire recruitment period in months, however, we found that 52% (12/23) of the studies had a better online compared to offline recruitment rate (IRR 1.11, P = 0.71). For cost-effectiveness we found that online recruitment had a significantly lower cost per enrollee compared to offline recruitment (72 USD vs. 199 USD, P = .04). Finally, we found that 69% of studies had significantly better offline compared to online conversion rates (RR 0.8, P = .02). CONCLUSIONS Targeting potential participants using online remedies, is an effective tool for patient recruitment for clinical research. Online recruitment was both superior in regards to time-efficiency and cost-effectiveness compared to offline recruitment strategies. Offline recruitment still outperforms online strategies with respect to conversion rate. CLINICALTRIAL Not registered.
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