Lessons learned by the TDN and changes implemented to address them
| Lessons learned | Actions to address challenges |
|---|---|
| In an expanding network, different sites have variable experience and knowledge base regarding conduct of clinical research | Defined education programmes including self-education modules, published standard operating procedures, etc |
| Variable performance in study start-up time and enrolment rate across TDN sites | Established a central database to track performance, provide sites real-time feedback, annual peer comparisons of metrics and a web-based quality improvement programme |
| Variability in important clinical endpoints and biomarkers can adversely impact interpretation of results | Established National Resource Centres to provide expertise in particular endpoints and provide quality assurance to individual TDCs. Established and published standard operating procedures for outcomes |
| Increase in number of interested sponsors and therapeutics to be tested creates stress on recruitment capabilities and study throughput | Steady expansion of clinical network through competitive renewal programme that emphasises performance metrics and quality study conduct |
| Variable experience and understanding of CF by industry sponsors | Developed TDN sponsored consulting programme to provide consistent advice to sponsors and to enable rapid development of clinical protocols |
CF, cystic fibrosis; TDC, Therapeutic Development Centre; TDN, Therapeutics Development Network.