Therapeutic drug monitoring (TDM) as intervention: A cross-sectional analysis of characteristics of 173 registered clinical trials.

BACKGROUND

To examine fundamental characteristics of clinical trials with therapeutic drug monitoring (TDM) as intervention on world major clinical trials registry platform.

METHODS

Cross-sectional analysis of clinical trials with TDM as intervention that were registered on WHO International Clinical Trials Registry Platform (ICTRP) or ClinicalTrials.gov. Relevant trial entries registered before and on March 2nd, 2022 were downloaded, deduplicated, and reviewed. Recruit country, monetary source, start years, study design, medical conditions, involved drugs, outcome measure, and subject information were extracted and analyzed.

RESULTS

Overall, 173 clinical trials were included in this study. Majority of the trials were conducted in several economically prosperous countries. The earliest initiated trials dates back to 2002. Most of the trials were funded by hospitals (36.4%). A higher proportion of trials were conducted within one country (86.1%), as phase Ⅳ (34.1%) interventional study (82.7%), randomized (52.6%), parallel assignment (53.8%) and open label (67.0%). The most concerned medical condition were infectious or parasitic disease and neoplasms, with the most monitored drugs were immunosuppressants and β-lactam antibacterials. Most of the trials enroll no more than 50 subjects (30.6%), with both gender (95.4%), and adults (67.0%).

CONCLUSION

The trials were mainly conducted in several economically prosperous countries. The number of registered trials had gradually increased during the past years. Novel biological drugs have increasingly become the research hotspot. We expect that with abundant financial support, more high-quality large-scale, multicenter randomized clinical trials (RCTs) are designed and implemented to promote the development of TDM in the future.