Tuesday, March 2, 2010

Phase 1 Clinical Trial Trends - Staffing by Position

Overall, because a Phase 1 clinical trial typically requires such a small number of patients compared to Phase 2 and 3, fewer FTEs are required to manage clinical study conduct and performance. In my experience and because of smaller patient numbers, simple resource trends surface relating to how to staff by position, a Phase 1 clinical trial.

In the last years, and on average, pharma typically outsourced 41% of staffing by position related to Phase 1 clinical trial activities, SOPS and tasks in 2006. This number, in the first quarter of 2010, increased to 59%. Clinical staffing by position, whether it be FTEs or outsourced, typically trends and follows a distribution profile - In-house FTEs/Outsourced, unless otherwise specified:
  • Clinical directors, VP - 100% FTEs
  • Clinical trial managers - 100% FTEs
  • Data management - 50%/50%
  • Medical writing - 100% FTEs
  • Biostatisticians/bioanalysis - 30%/70%
  • Regulatory - 100% FTEs
  • Clinical quality control - 100% FTEs
  • Clinical quality assurance - 100% FTEs
  • Clinical trials supplies - 100% FTEs
  • CMC - 100% FTEs
  • Contract management - 25%/75%
  • Drug safety - 50%/50%
  • Pharmacovigilance - 45%/55%.

A Phase 1 clinical trial can be simply and concisely budgeted with early planning development with respect to the clinical protocol and statistical analysis plan. Due to Phase 1 clinical trial simplicity in design, easily measured endpoints, most commonly, patient safety and tolerance, new chemical entity proof of concept design and small numbers of patients involved - the budget can be exact, the ROI easily achieved, results quickly analyzed. A Phase 1 clinical trial resource distribution profile, staffing by position, as seen above, demonstrates that pharma, at this clinical level of drug development maintains staffing by position in-house. Why? During the Phase 1 clinical trial period of drug development - this is the time for pharma take a go/no go decision with respect to the future development of the drug. The decision must come from pharma and only after careful consideration and review of Phase 1 clinical trial data. I strongly advise that go/no go decisions pertaining to Phase 1 clinical trial continuance or not, remain the responsibility and accountability of pharma. Guidance from FDA recommends the same good clinical practice. Plan early, resource and staff by position accurately and appropriately, follow good clinical practice, design concise clinical protocols and SAPs. The Phase 1 clinical trial is the least expensive trial (or should be) in the clinical drug development process and path to regulatory clinical submission.

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