Objectives
The primary objectives of this study were to assess:
- A Comparative study looking at the impact and potential efficacy of an intra-operative washing solution with a 1 litre post-operative instillate in the reduction of post-operative de novo adhesion formation within the abdominal cavity following ‘virgin’ laparoscopic surgery for fibroids or endometriotic cysts.
- The potential impact of --- in reducing the extent and severity of de novo adhesion formation within the abdominal cavity following ‘virgin’ laparoscopic surgery for fibroids or endometriotic cysts, compared with lactated Ringer’s solution (LRS) .
The secondary objectives of this study were to assess the potential impact in reducing reformation of any pre-existing and lysed adhesions (around the ovarian fossa) following ‘virgin’ laparoscopic gynaecological surgery on patients with endometriotic cysts.
Scope
Allow the investigator sites (key prescribers) to have hands-on experience in 330 patients in 29 sites in
Challenges
Capturing the video images was the big challenge (technical and logistical).
Client’s request to work with a third party vendor to select sites.
Solutions
The video technology initially proved difficult for the investigators to use but was quickly addressed by provision of additional training to achieve data gathering targets.
Clear allocation of roles and responsibilities with a client specified third party vendor who selected the sites and were involved in the CRO selection process.
Outcome
Resourcing well managed by allocation of appropriately experienced key team members at start up. Start up of projects crucial to overall success so even though study looks simple and straightforward, assigning higher level key team members was justified in building credibility with this new client.
Objectives
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.
Scope
2720 patients in 575 sites in France, Canada, Sweden and Finland, addressing PM, DM, clinical, statistics, medical writing
Challenges
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.
Solutions
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.
Outcome
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.