A bridging trial of an FDA-approved therapeutic drug for Dupuytren’s Contracture
To assure the success of our client’s business strategy, DOT investigated the medical situation and market requirement of Dupuytren’s Contracture in Japan. We gathered related information and discussed it with our client.
After our client realized therapeutic situations in Japan, we started to design the protocol.
At the same time, we summed up the necessary points of a bridging study and negotiated the detailed
criteria with the Pharmaceuticals and Medical Devices Agency(PMDA).
Due to the clear and articulate communication with the PMDA, we finished the modified protocol and PMDA negotiation in two weeks, whereas several months had been planned for this milestone by the study sponsor.
To assure the success of the trial, we held a kick-off meeting, inviting the medical experts from our client to meet with renowned medical experts in Japan. Participants exchanged the latest information and communicated very well with each other, which unified the trial team members.
Due to the low prevalence of Dupuytren’s Contracture, DOT finally selected 30 sites for more than 100 subjects. Even with the great number of trial sites, thanks to our well-prepared investigation and deep communication with related medical sites, we advanced the enrollment plan by 2 months to 10 months.
During execution of the study, we succeeded in shortening the enrollment period two more months to 8 months.
During the trial, we supported the drug delivery process, IRB application, CRF development, monitoring operations, contracts and accounts.
To make the drug available for the market as soon as possible, DOT began the preparation of the product release requirements during the trial.
We are now preparing the required documents for a New Drug Application (NDA). All of the new drugs we supported before were approved within 1 year.
After the drug is approved in Japan, DOT will continue to support the drug with post-marketing pharmacovigilance and business consulting services.
