Case study
Overview
TFS was selected to provide full CRO services including site identification/initiation/training; patient enrollment; project management/monitoring; data management; biostatistics & programming; medical writing, safety, medical monitoring and regulatory consulting. This open study required close follow up on safety and disease.
- Part One: (Dose Escalation): 3 sites
- Part Two: (Dose Expansion): 6 sites
- Study Phase: First in Man, I/IIb
- Indication: Solid Tumors
- Sites: 6
- Services: Full Service
Challenges
Part One:
- Quick patient enrollment required per cohort. Significant competition with similar oncology treatment trials
- Close follow-up needed on safety and progressive disease.
- Complex process to get AIOM/SIAPEC certification for local labs for solid biopsies.
- Close PK/PD sample management required.
- Rapid safety data delivery required for the DSMB for each cohort
Part Two:
Slow recruitment was caused by the following factors:
- The disease indications allowed had been reduced to four cohorts, with more incidence of target receptor expression versus all epithelial cancer in part one
- Mandatory paired biopsies were required for 60% of the patients. In some of the indications the biopsies were not easy do obtain due the location of the lesions
- Previous chemotherapy lines were restricted to 3 treatments in part two.
