Patient Recruitment for Melanoma Immunotherapy Trial

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Situation

An innovative biotech company that specializes in developing DNA-based intratumoral immunotherapies needed help in recruiting patients unresponsive to anti-PD-1 therapy into a stage III/IV melanoma trial.

Analysis

Phesi worked with the CEO and Chief Clinical and Regulatory Officer over a 4-week period to conduct a competitive analysis, reviewing enrollment rates in top recruiting centers across 39 recent, relevant trials:

Phesi recommended extending the current number of trial centres (7) by an additional 10 sites from either Germany or the US, and identified a list of 45 investigators. Phesi also assessed sites in Australia, the US and Canada (nominated by the client and partner CRO). Phesi forecasted the enrollment duration to be 19 months to recruit 63 patients.

Solution

Phesi provided the following information in a client report:

STRATEGIC SERVICES

Feasibility planning

  • Identified opportunities to optimize trial design at the protocol level
  • Detailed the competitive environment (e.g. historical development, competing programs, protocols and amendments)
  • Identified PIs and leading countries

Protocol feasibility

  • Identified operational parameters (e.g., site numbers, countries, inclusion/exclusion criteria, site list)
  • Forecasted operational deliverables (e.g., site activation timelines, enrollment cycle times globally)

OPERATIONAL SERVICES

Site feasibility

  • Identified the best site candidates by country
  • Provided detailed site competition analysis to inform discussion with site candidate
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