TableĀ 3

Lessons learned by the TDN and changes implemented to address them

Lessons learnedActions to address challenges
In an expanding network, different sites have variable experience and knowledge base regarding conduct of clinical researchDefined education programmes including self-education modules, published standard operating procedures, etc
Variable performance in study start-up time and enrolment rate across TDN sitesEstablished 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 resultsEstablished 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 throughputSteady expansion of clinical network through competitive renewal programme that emphasises performance metrics and quality study conduct
Variable experience and understanding of CF by industry sponsorsDeveloped 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.