Case Study: Phase lllB/lV#2
The primary objective is to descriptively assess the efficacy and safety of a new antidepressant in patients previously treated with a specific Selective Serotonin Reuptake Inhibitor.
The client aim for this program was to have a core protocol which allowed collation of primary and secondary objectives, but at the same time was flexible enough that it could allow local protocols to be adapted to local office marketing needs and regulatory requirements. This meant that corporate was able to be provided data on a large global program, while local office needs were met as well.
2720 patients in 575 sites in France, Canada, Sweden and Finland, addressing PM, DM, clinical, statistics, medical writing.
To ensure a consistent central approach to maintain the core protocol and central corporate needs, but at the same time, allowing the flexibility to allow each program to be managed locally by the affiliate.
• Each study was resourced using local CRAs and clinical trial coordinators. Therefore language was never an issue and did enable CRF and other study documentation / meetings to be in local language. This helped with recruitment and retention of investigators.
• In each country a clinical trial coordinator (CTC) was appointed to act as local representative and communication point for the client affiliate. Local decisions were made at this level, i.e. number of sites, local adaptation of the core protocol to fit marketing and regulatory needs. Centrally the PM co-ordinated the communication across affiliates and with client corporate. In addition the PM ensured common approach and processes to the studies to ensure consistency.
This required flexibility to adapt to local needs, but maintaining a central core approach which enabled same process, database set up etc to be used for each study. This approach did require clear communication and decision making channels; this was managed through weekly teleconferences with CTCs and the client at local and corporate level.