T-12: Risk-Adapted Monitoring Approach in Academic Medical Center: What we Learned From Multi-Center Investigator Sponsored Trials
Young Lan Hong
ASAN Medical Center Korea, Republic of
To investigate the experience on risk-adapted monitoring approach in oncology multi-center clinical trial to Investigator Sponsored Trials(ISTs).
ORAL PRESENTATION: 1:00PM
This is a retrospective descriptive study to look over advantage and disadvantage of on-site and remote monitoring in ISTs. We selected 3 oncology clinical trials monitored by Asan Medical Center ARO which studies were conducted different monitoring method from 2014 to 2017.
The PENELOPEB trial was primary breast cancer and classified K1 (risk high) according to ADAMON method and the monitoring plan was designed mainly performing on-site monitoring. EGPG studied in patients with metastatic breast cancer. Mixed method, on-site and remote monitoring, was planned and classified K2 (Intermediate) before the start of the trial. The AXEPT trial was a metastatic colorectal cancer trial classified as K3 (low risk), and the monitoring was conducted mostly via remote monitoring.
During the observation period, the PENELOPEB trial conducted 42 on-site monitoring with 1093 monitoring findings in South Korea. The EGPG trial conducted 19 on-site monitoring and 60 remote monitoring, which resulted in 750 on-site findings and 658 remote findings. The AXEPT trial conducted 8 on-site monitoring and 189 remote monitoring, which resulted in 38 on-site findings and 3056 remote findings.
For primary endpoint data, the percentages of queries with data points changed following monitoring activity in PENELOPEB, EGPG and AXEPT trials were 0.7%, 2.3%, and 1.7%, respectively. There is no big difference between each trials monitoring method. On the other hand, queries related to patient rights (informed consent form, inclusion criteria) accounted for 16.7% of the total query in the PENELOPEB trial and 4.2% in the AXEPT trial.
Cost-per-findings were lower by 18.9% with on-site monitoring compared with on-site monitoring.
This data suggests that remote monitoring is feasible in multicenter ISTs. Remoting monitoring could capture primary endpoint data by similar degree, but has disadvantage to detect queries related to patient rights compared with on-site monitoring. Based on risk and budgets, optimal monitoring plan should be designed. Further prospective validation is needed to offer best monitoring method.