Unique aspects of the network include the use of internet applications for study conduct and communication, the development of statistical methodology to enhance the efficiency of clinical trial design, the development of outcome measures specific to Cystic Fibrosis, and the development of infrastructure necessary for expediting protocol development.
Such an approach can enhance the ability of investigators to develop clinically detailed and realistic simulation models for trial design, protocol development, and cost-effectiveness analysis.
Improvements in trial design, including development of consortia for the conduct of national and international multicenter studies and use of standardized classification and outcome measures coupled with the emergence of newer biologic, immunomodulatory, and small molecule agents, hopefully will result in the addition of disease-modifying agents to the armamentarium.
This is a different molecule, a trial design and development path that is mature and sophisticated, and they beefed up their management team".
The consulting involved trial design, protocol development, study initiation, medical and safety monitoring, final data review and Clinical Study Report preparation for this Phase I trial.
She has lectured throughout the world and provided advice and guidance to pharmaceutical companies, medical personnel and academic researchers on the incorporation of outcome measurement into pharmaceutical product development strategies, clinical trial design and questionnaire development, translation, adaptation and validation.
Challenges include the use of adaptive trial designs, the development of standardised, sensitive outcome measures, and the need for interventions that can be implemented in resource-poor settings.
Major themes explored include: (i) scrutiny of best-level evidence outcomes of both MIPR Distal Pancreatectomy (DP) and pancreatoduodenectomy (PD), (ii) Cost/Value/Quality of Life assessment of MIPR, (iii) topics in training, education and credentialing, and (iv) development of best approaches to analyze results of MIPR – including clinical trial design and registry development.
Thus, several issues related to clinical trial design and drug development need to be considered.
