Study Assessing Practices and Inefficiencies Associated with Site Selection, Study Startup and Site Activation

Tufts CSDD START II Research Report
Based on the previous research on benchmarking clinical trial initiations and the wide variation and inconsistency among organizations, Tufts CSDD conducted a follow up study examining practices and inefficiencies in site selection, study start and site activation. In-depth interviews were conducted with senior level pharmaceutical and CRO executives to better understand the challenges and overall strategies that organizations are using to improve these activities.

Respondents represented 13 biopharmaceutical companies and 8 CROs across 13 large and 8 mid-sized and small organizations. Interviewees were experienced and were primarily senior level executives occupying director level roles or above.

Areas examined in the research include:

  • Key criteria utilized to qualify and identify investigative sites.
  • How practices vary across organizations in regards to the qualification and identification of investigative sites.
  • Use of repeat sites, experience level of sites, and therapeutic expertise were factors investigated.
  • Novel practices adopted by companies and any solutions currently being planned and implemented were identified.
  • Use of performance indicators including; historical site data, and perceived or measured impact on cycle times and cost were identified.