Success story - CNS
"By incorporating I-TMM in the clinical trial, we are assured that the patients come closer to protocol-specified dosing regimen"
One of our clients has incorporated I-TMM in the ongoing phase II clinical trial of a compound to treat a CNS disorder. The clinical trial is conducted with about 700 patients at about 50 clinical sites. Past experience showed that patients treated with this type of compound discontinued their treatment earlier than planned. They also found out that a substantial fraction of patients who were judged ‘treatment-resistant’ were clinically unrecognized non-adherers to the prescribed drug dosing regimen. The main challenge in this study is to optimize patient exposure to the test drug and especially to avoid early discontinuation of the treatment.
By incorporating I-TMM in the program, our client has managed to maintain a low rate of early discontinuation. Both the investigators and the patients at each site have been empowered by having access to each patient’s dosing history. Patients’ dosing histories have become the basis of the dialogue between investigators and patients on medication-taking. The regular updates for the study manager have been useful to assess clinical sites that need more support. She has detected which sites are slowest to recruit, which sites with patients who are slow to start dosing, and which sites have gotten the dosing regimen wrong. The study manager stated that by having these updates, she felt assured that the patients have indeed come closer to the protocol-specified dosing regimen.
